Pub Date : 2024-03-18DOI: 10.25251/skin.8.supp.388
Michael Migden, M. Kheterpal, Brent Moody, Kunal Patel, Leonard Lionnet, Sakthivel Sivam, Joe Conti, N. Squittieri, Aaron Farberg
Introduction: Sonidegib, a Hedgehog (HH) pathway inhibitor, is approved for the treatment of locally advanced basal cell carcinoma (laBCC) not amenable to curative surgery or radiation. The pivotal 42-month BOLT (NCT01327053) study demonstrated sustained efficacy and manageable safety of sonidegib. Prior analyses at 18 months demonstrated clinical benefit persisting beyond sonidegib discontinuation. Pharmacokinetic modeling suggests HH pathway inhibition can be maintained following discontinuation. This analysis presents the efficacy of sonidegib 200 mg daily in patients with laBCC who discontinued treatment without disease progression (PD) at 42 months (end of study). Methods: BOLT was a randomized, double-blind, placebo-controlled, Phase 2 study. Objective response rates (ORRs; complete response + partial response), duration of response (DOR), and progression-free survival (PFS) were assessed by central and investigator review per modified response evaluation criteria in solid tumors (mRECIST). Adverse events (AEs) were also assessed. Results: Of the 66 patients with laBCC randomized to sonidegib 200 mg daily, 37 discontinued treatment without PD. The ORRs for these patients per central (57% [n = 20]) and investigator (73% [n = 27]) review were similar to the overall patient population (61% [n = 40] and 71% [n = 47] per central and investigator review, respectively). For patients who discontinued treatment, the median (95% confidence interval [CI]) DOR per central and investigator review was not estimable (NE) and 20.2 months (12.0, NE), respectively. The median PFS (95% CI) per central and investigator review was NE and 22.0 months (16.6, NE), respectively. Most AEs were Grades 1/2 in severity. Conclusion: In this 42-month analysis among patients with laBCC who received sonidegib 200 mg daily, clinical benefit was observed beyond treatment discontinuation during this study.
{"title":"Efficacy Following Discontinuation of Sonidegib Treatment in Patients With Locally Advanced Basal Cell Carcinoma: Results From the BOLT 42-Month Analysis","authors":"Michael Migden, M. Kheterpal, Brent Moody, Kunal Patel, Leonard Lionnet, Sakthivel Sivam, Joe Conti, N. Squittieri, Aaron Farberg","doi":"10.25251/skin.8.supp.388","DOIUrl":"https://doi.org/10.25251/skin.8.supp.388","url":null,"abstract":"Introduction: Sonidegib, a Hedgehog (HH) pathway inhibitor, is approved for the treatment of locally advanced basal cell carcinoma (laBCC) not amenable to curative surgery or radiation. The pivotal 42-month BOLT (NCT01327053) study demonstrated sustained efficacy and manageable safety of sonidegib. Prior analyses at 18 months demonstrated clinical benefit persisting beyond sonidegib discontinuation. Pharmacokinetic modeling suggests HH pathway inhibition can be maintained following discontinuation. This analysis presents the efficacy of sonidegib 200 mg daily in patients with laBCC who discontinued treatment without disease progression (PD) at 42 months (end of study). \u0000Methods: BOLT was a randomized, double-blind, placebo-controlled, Phase 2 study. Objective response rates (ORRs; complete response + partial response), duration of response (DOR), and progression-free survival (PFS) were assessed by central and investigator review per modified response evaluation criteria in solid tumors (mRECIST). Adverse events (AEs) were also assessed. \u0000Results: Of the 66 patients with laBCC randomized to sonidegib 200 mg daily, 37 discontinued treatment without PD. The ORRs for these patients per central (57% [n = 20]) and investigator (73% [n = 27]) review were similar to the overall patient population (61% [n = 40] and 71% [n = 47] per central and investigator review, respectively). For patients who discontinued treatment, the median (95% confidence interval [CI]) DOR per central and investigator review was not estimable (NE) and 20.2 months (12.0, NE), respectively. The median PFS (95% CI) per central and investigator review was NE and 22.0 months (16.6, NE), respectively. Most AEs were Grades 1/2 in severity. \u0000Conclusion: In this 42-month analysis among patients with laBCC who received sonidegib 200 mg daily, clinical benefit was observed beyond treatment discontinuation during this study.","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140232940","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-18DOI: 10.25251/skin.8.supp.383
Alice B. Gottlieb, April W. Armstrong, Joseph F. Merola, A. Napoli, M. Nowak, Subhashis Banerjee, Thomas Lehman, Philip Mease
Introduction: Deucravacitinib (DEUC), an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy. DEUC was superior to apremilast and placebo (PBO) in two phase 3 trials in patients with moderate to severe PsO. DEUC was efficacious on multiple measures of arthritis severity vs PBO in a phase 2 trial in patients with active psoriatic arthritis (PsA) who had ≥1 PsO lesion (≥2 cm). In patients with body surface area (BSA) involvement ≥3% at baseline (80% of patients in this trial), a greater proportion achieved PASI 75 with DEUC (6 mg QD: 42.4%, P=0.01; 12 mg QD: 59.6%, P<0.0001) vs PBO (20.4%) at Week 16. This analysis evaluated the impact of DEUC on PsO in patients with PsA in the phase 2 trial (NCT03881059). Methods: The phase 2 double-blind PsA trial randomized patients (N=203) 1:1:1 to PBO, DEUC 6 mg once daily (QD), or DEUC 12 mg QD. After Week 16, patients could enroll in an optional, double-blind period until Week 52. DEUC-treated patients achieving minimal disease activity at Week 16 continued DEUC to Week 52. PsO disease activity measurements were assessed. Results: Baseline PsO characteristics were comparable across groups. At Week 16, significant decreases from baseline in mean PASI were observed with DEUC vs PBO in patients with baseline BSA ≥3%-<10% or PASI ≤12 even with very low baseline PASI scores, and also in those with baseline BSA ≥10% and PASI >12. Significant decreases in PASI from baseline were observed with DEUC vs PBO in patients with background csDMARD use (DEUC 6 mg, -4.0 and 12 mg, -4.9 vs PBO, -2.3; both P<0.05) and those without csDMARD use (-3.7 and -4.0 vs -2.5, respectively; both P<0.001). At Week 16, greater proportions of DEUC vs PBO patients achieved PASI ≤1 with baseline BSA ≥3% (DEUC 6 mg: 32.2%; DEUC 12 mg: 44.2%; PBO: 18.5%) and in patients with baseline BSA ≥10% and PASI >12 (23.1%; 28.6%; 0.0%). In patients with baseline BSA ≥3%, decreases in mean PASI at Week 16 were maintained through Week 52 in patients continuing DEUC 6 mg (absolute PASI score, Week 16: 2.39, Week 52: 1.22) and 12 mg (Week 16: 0.64, Week 52: 0.24). Conclusion: DEUC significantly improved PsO in patients with PsA, regardless of baseline PsO severity and background csDMARD use. Improvement was comparable to that observed in the phase 3 POETYK PSO-1 trial.
{"title":"Impact of Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, Deucravacitinib, on Psoriasis in Patients with Active Psoriatic Arthritis: Results from a Phase 2 Trial","authors":"Alice B. Gottlieb, April W. Armstrong, Joseph F. Merola, A. Napoli, M. Nowak, Subhashis Banerjee, Thomas Lehman, Philip Mease","doi":"10.25251/skin.8.supp.383","DOIUrl":"https://doi.org/10.25251/skin.8.supp.383","url":null,"abstract":"Introduction: Deucravacitinib (DEUC), an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy. DEUC was superior to apremilast and placebo (PBO) in two phase 3 trials in patients with moderate to severe PsO. DEUC was efficacious on multiple measures of arthritis severity vs PBO in a phase 2 trial in patients with active psoriatic arthritis (PsA) who had ≥1 PsO lesion (≥2 cm). In patients with body surface area (BSA) involvement ≥3% at baseline (80% of patients in this trial), a greater proportion achieved PASI 75 with DEUC (6 mg QD: 42.4%, P=0.01; 12 mg QD: 59.6%, P<0.0001) vs PBO (20.4%) at Week 16. This analysis evaluated the impact of DEUC on PsO in patients with PsA in the phase 2 trial (NCT03881059). \u0000Methods: The phase 2 double-blind PsA trial randomized patients (N=203) 1:1:1 to PBO, DEUC 6 mg once daily (QD), or DEUC 12 mg QD. After Week 16, patients could enroll in an optional, double-blind period until Week 52. DEUC-treated patients achieving minimal disease activity at Week 16 continued DEUC to Week 52. PsO disease activity measurements were assessed. \u0000Results: Baseline PsO characteristics were comparable across groups. At Week 16, significant decreases from baseline in mean PASI were observed with DEUC vs PBO in patients with baseline BSA ≥3%-<10% or PASI ≤12 even with very low baseline PASI scores, and also in those with baseline BSA ≥10% and PASI >12. Significant decreases in PASI from baseline were observed with DEUC vs PBO in patients with background csDMARD use (DEUC 6 mg, -4.0 and 12 mg, -4.9 vs PBO, -2.3; both P<0.05) and those without csDMARD use (-3.7 and -4.0 vs -2.5, respectively; both P<0.001). At Week 16, greater proportions of DEUC vs PBO patients achieved PASI ≤1 with baseline BSA ≥3% (DEUC 6 mg: 32.2%; DEUC 12 mg: 44.2%; PBO: 18.5%) and in patients with baseline BSA ≥10% and PASI >12 (23.1%; 28.6%; 0.0%). In patients with baseline BSA ≥3%, decreases in mean PASI at Week 16 were maintained through Week 52 in patients continuing DEUC 6 mg (absolute PASI score, Week 16: 2.39, Week 52: 1.22) and 12 mg (Week 16: 0.64, Week 52: 0.24). \u0000Conclusion: DEUC significantly improved PsO in patients with PsA, regardless of baseline PsO severity and background csDMARD use. Improvement was comparable to that observed in the phase 3 POETYK PSO-1 trial. \u0000 \u0000 \u0000 \u0000 \u0000 \u0000 \u0000 \u0000 \u0000 \u0000 ","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140233878","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-18DOI: 10.25251/skin.8.supp.371
Bruce Strober, Matthias Augustin, Yayoi Tada, Amit Garg, D. Jullien, Alice B. Gottlieb, Johann Gudjonsson, Na Hu, Patrick Hofmann, C. Thoma, Angelo Marzano
Introduction & Objectives: Generalized pustular psoriasis (GPP) is a chronic, rare and potentially life-threatening skin disease, characterized by flares of sterile pustules. Spesolimab, an anti-interleukin-36 receptor monoclonal antibody, is an effective and approved treatment for GPP flares in adults. Effisayil 2 (NCT04399837) was a pivotal, randomized controlled trial that evaluated the efficacy and safety of subcutaneous spesolimab in preventing GPP flares. Here, we report the effect of high-dose spesolimab versus placebo on GPP lesions. Materials & Methods: Eligible patients with a history of GPP were randomized (1:1:1:1) to receive one of three subcutaneous spesolimab regimens or placebo for 48 weeks. High-dose spesolimab regimen was loading dose 600 mg, followed by maintenance dose 300 mg every 4 weeks. GPP Physician Global Assessment (GPPGA) subscores for erythema, pustules and scaling/crusting, and total score were compared between high-dose spesolimab and placebo groups at baseline and over the treatment period (scale: 0, clear to 4, severe). Results: Proportion of patients with baseline score of 0 for each GPPGA subscore and total score was generally similar between treatment groups, except erythema; (high-dose spesolimab [n=30] vs placebo [n=31]: erythema, 13.3% vs 22.6%; pustules, 66.7% vs 67.7%; scaling/crusting, 23.3% vs 22.6%; total score, 10.0% vs 12.9%). By Week 4, proportion of patients with scores of 0 increased with high-dose spesolimab versus placebo, (erythema, 33.3% vs 19.4%; pustules, 80.0% vs 41.9%; scaling/crusting, 30.0% vs 19.4%; total score, 26.7% vs 16.1%), and high-dose spesolimab group had fewer flares (10.0% vs 35.5%). This trend was maintained at Week 24 (erythema, 36.7% vs 22.6%; pustules, 63.3% vs 45.2%; scaling/crusting, 36.7% vs 19.4%; total score, 33.3% vs 19.4%) and Week 48 (erythema, 36.7% vs 22.6%; pustules, 66.7% vs 45.2%; scaling/crusting, 43.3% vs 25.8%; total score, 36.7% vs 22.6%). There were no new flares after Week 4 in high-dose spesolimab group; however, flares increased with placebo (45.2% at Week 24; 51.6% at Week 48). Conclusion: Versus placebo, high-dose subcutaneous spesolimab resulted in a greater proportion of patients maintaining GPPGA scores of 0, a lower proportion having flares at Week 4, and no new flares after Week 4. This was sustained at Weeks 24 and 48.
简介和目标：泛发性脓疱型银屑病（GPP）是一种慢性、罕见且可能危及生命的皮肤病，其特点是无菌性脓疱复发。斯派索利单抗是一种抗白细胞介素-36受体的单克隆抗体，是治疗成人脓疱型银屑病复发的有效药物，并已获得批准。Effisayil 2（NCT04399837）是一项关键性随机对照试验，评估了皮下注射斯派索利单抗预防GPP复发的有效性和安全性。在此，我们报告了大剂量斯派索利单抗与安慰剂相比对 GPP 病变的影响。材料与方法：有 GPP 病史的合格患者随机（1:1:1:1:1）接受三种皮下注射斯派索利单抗方案或安慰剂中的一种，为期 48 周。高剂量斯派索利单抗方案为负荷剂量 600 毫克，随后每 4 周维持剂量 300 毫克。比较了大剂量斯派索利单抗组和安慰剂组在基线和治疗期间的红斑、脓疱、脱屑/结痂的GPP医生总体评估（GPPGA）子评分和总评分（评分标准：0分，无明显症状至4分，严重）。结果除红斑外，各治疗组 GPPGA 子评分和总评分基线为 0 分的患者比例基本相似（大剂量斯派索利单抗[n=30] vs 安慰剂[n=31]：红斑，13.3% vs 22.6%；脓疱，66.7% vs 67.7%；脱屑/结痂，23.3% vs 22.6%；总分，10.0% vs 12.9%）。到第4周时，大剂量斯派索利单抗与安慰剂相比，得分为0的患者比例有所增加（红斑，33.3% vs 19.4%；脓疱，80.0% vs 41.9%；脱屑/结痂，30.0% vs 19.4%；总分，26.7% vs 16.1%），而且大剂量斯派索利单抗组的复发率较低（10.0% vs 35.5%）。这一趋势在第24周（红斑，36.7% vs 22.6%；脓疱，63.3% vs 45.2%；脱屑/结痂，36.7% vs 19.4%；总分，33.3% vs 19.4%）和第48周（红斑，36.7% vs 22.6%；脓疱，66.7% vs 45.2%；脱屑/结痂，43.3% vs 25.8%；总分，36.7% vs 22.6%）保持不变。大剂量斯派索利单抗组在第4周后没有出现新的复发；但安慰剂组的复发率有所增加（第24周为45.2%；第48周为51.6%）。结论与安慰剂相比，大剂量皮下注射斯派索利单抗可使更多患者的GPPGA评分维持在0分，降低第4周复发的比例，并且在第4周后不再出现新的复发。这种情况在第24周和第48周得以持续。
{"title":"Effect of High-Dose Subcutaneous Spesolimab on Skin Manifestations: Results from the Pivotal Effisayil 2 Trial of Flare Prevention in Generalized Pustular Psoriasis","authors":"Bruce Strober, Matthias Augustin, Yayoi Tada, Amit Garg, D. Jullien, Alice B. Gottlieb, Johann Gudjonsson, Na Hu, Patrick Hofmann, C. Thoma, Angelo Marzano","doi":"10.25251/skin.8.supp.371","DOIUrl":"https://doi.org/10.25251/skin.8.supp.371","url":null,"abstract":"Introduction & Objectives: Generalized pustular psoriasis (GPP) is a chronic, rare and potentially life-threatening skin disease, characterized by flares of sterile pustules. Spesolimab, an anti-interleukin-36 receptor monoclonal antibody, is an effective and approved treatment for GPP flares in adults. Effisayil 2 (NCT04399837) was a pivotal, randomized controlled trial that evaluated the efficacy and safety of subcutaneous spesolimab in preventing GPP flares. Here, we report the effect of high-dose spesolimab versus placebo on GPP lesions. \u0000Materials & Methods: Eligible patients with a history of GPP were randomized (1:1:1:1) to receive one of three subcutaneous spesolimab regimens or placebo for 48 weeks. High-dose spesolimab regimen was loading dose 600 mg, followed by maintenance dose 300 mg every 4 weeks. GPP Physician Global Assessment (GPPGA) subscores for erythema, pustules and scaling/crusting, and total score were compared between high-dose spesolimab and placebo groups at baseline and over the treatment period (scale: 0, clear to 4, severe). \u0000Results: Proportion of patients with baseline score of 0 for each GPPGA subscore and total score was generally similar between treatment groups, except erythema; (high-dose spesolimab [n=30] vs placebo [n=31]: erythema, 13.3% vs 22.6%; pustules, 66.7% vs 67.7%; scaling/crusting, 23.3% vs 22.6%; total score, 10.0% vs 12.9%). By Week 4, proportion of patients with scores of 0 increased with high-dose spesolimab versus placebo, (erythema, 33.3% vs 19.4%; pustules, 80.0% vs 41.9%; scaling/crusting, 30.0% vs 19.4%; total score, 26.7% vs 16.1%), and high-dose spesolimab group had fewer flares (10.0% vs 35.5%). This trend was maintained at Week 24 (erythema, 36.7% vs 22.6%; pustules, 63.3% vs 45.2%; scaling/crusting, 36.7% vs 19.4%; total score, 33.3% vs 19.4%) and Week 48 (erythema, 36.7% vs 22.6%; pustules, 66.7% vs 45.2%; scaling/crusting, 43.3% vs 25.8%; total score, 36.7% vs 22.6%). There were no new flares after Week 4 in high-dose spesolimab group; however, flares increased with placebo (45.2% at Week 24; 51.6% at Week 48). \u0000Conclusion: Versus placebo, high-dose subcutaneous spesolimab resulted in a greater proportion of patients maintaining GPPGA scores of 0, a lower proportion having flares at Week 4, and no new flares after Week 4. This was sustained at Weeks 24 and 48. ","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140233885","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-18DOI: 10.25251/skin.8.supp.396
John R. Ingram, Martina Porter, Raj Chovatiya, E. Giamarellos‐Bourboulis, Falk G. Bechara, Hideki Fujita, Wayne Gulliver, Edward Muller, Muhammad Bari, Robert Rolleri, Rob Byerly, Joslyn S Kirby
N/A
不适用
{"title":"Bimekizumab Response Maintenance to 48 Weeks in Patients with Moderate to Severe Hidradenitis Suppurativa: Pooled Responder Analysis from the Phase 3, Double-Blind, Placebo-Controlled, Randomized Clinical Trials BE HEARD I and II","authors":"John R. Ingram, Martina Porter, Raj Chovatiya, E. Giamarellos‐Bourboulis, Falk G. Bechara, Hideki Fujita, Wayne Gulliver, Edward Muller, Muhammad Bari, Robert Rolleri, Rob Byerly, Joslyn S Kirby","doi":"10.25251/skin.8.supp.396","DOIUrl":"https://doi.org/10.25251/skin.8.supp.396","url":null,"abstract":"<jats:p>N/A</jats:p>","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140231535","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ahmed Sorour, Caroline Kruithoff, A. Gamal, Moustafa Hassan Elhelw, Ahmed Sayed Zakaria El Sayed, Amani Abdelrahman, Yehia El-Refaie
Nevus lipomatosus cutaneous superficialis (NLCS) is a rare hamartomatous condition characterized by ectopic mature adipose tissue. We are reporting a case of a 12-year-old female with soft, non-tender, pedunculated nodules with a cerebriform surface over her right lower back. The lesion fulfilled the criteria of the classic type of NLCS and was surgically removed with no visible recurrence on follow up.
{"title":"Nevus Lipomatosus Cutaneous Superficialis: A Case Report in Egypt","authors":"Ahmed Sorour, Caroline Kruithoff, A. Gamal, Moustafa Hassan Elhelw, Ahmed Sayed Zakaria El Sayed, Amani Abdelrahman, Yehia El-Refaie","doi":"10.25251/skin.8.2.11","DOIUrl":"https://doi.org/10.25251/skin.8.2.11","url":null,"abstract":"Nevus lipomatosus cutaneous superficialis (NLCS) is a rare hamartomatous condition characterized by ectopic mature adipose tissue. We are reporting a case of a 12-year-old female with soft, non-tender, pedunculated nodules with a cerebriform surface over her right lower back. The lesion fulfilled the criteria of the classic type of NLCS and was surgically removed with no visible recurrence on follow up.","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140231574","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: Subacute cutaneous lupus erythematosus (SCLE) is one of the cutaneous lupus erythematous subtypes. Being an autoimmune condition in nature, its diagnosis requires compatible clinical presentation with histopathological findings. Objective: To present a subacute cutaneous lupus erythematosus with granuloma formation. Case Report: A 56- year-old woman presented with longstanding red plaques on her face, trunk, and extremities. Two skin biopsies were performed during two different visits. The results showed tuberculoid leprosy and multiple granuloma annulare. She was treated accordingly for years with no improvement in her condition. Later, the third skin biopsy with CD123 immunohistochemical stain was done. The result was most consistent with cutaneous lupus erythematosus. Together with her clinical findings, she was finally diagnosed with SCLE. Her rashes resolved after being treated with hydroxychloroquine and topical steroid. Conclusion: The diagnosis of SCLE must be made based on both clinical presentations and histopathological findings.
{"title":"Histopathological Granuloma Formation in a Subacute Cutaneous Lupus Erythematosus Patient","authors":"Nattanicha Chaisrimaneepan","doi":"10.25251/skin.8.2.17","DOIUrl":"https://doi.org/10.25251/skin.8.2.17","url":null,"abstract":"Introduction: Subacute cutaneous lupus erythematosus (SCLE) is one of the cutaneous lupus erythematous subtypes. Being an autoimmune condition in nature, its diagnosis requires compatible clinical presentation with histopathological findings.\u0000Objective: To present a subacute cutaneous lupus erythematosus with granuloma formation.\u0000Case Report: A 56- year-old woman presented with longstanding red plaques on her face, trunk, and extremities. Two skin biopsies were performed during two different visits. The results showed tuberculoid leprosy and multiple granuloma annulare. She was treated accordingly for years with no improvement in her condition. Later, the third skin biopsy with CD123 immunohistochemical stain was done. The result was most consistent with cutaneous lupus erythematosus. Together with her clinical findings, she was finally diagnosed with SCLE. Her rashes resolved after being treated with hydroxychloroquine and topical steroid.\u0000Conclusion: The diagnosis of SCLE must be made based on both clinical presentations and histopathological findings.","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140233670","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-18DOI: 10.25251/skin.8.supp.392
Julie C Harper, L. Stein Gold, Hilary Baldwin, Valerie Callender, Michael Gold, Heather Woolery-Lloyd, L. Kircik
Introduction: While acne is common in adolescents, the overall prevalence in adults is increasing, especially among females. In addition, acne in older females is associated with greater negative impacts on quality of life. Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% (CAB) gel—the first fixed-dose, triple-combination topical product approved for acne—has demonstrated good efficacy, safety, and tolerability in participants with moderate-to-severe acne. The objective of this analysis is to assess the impact of age on efficacy, safety, and tolerability in females with moderate-to-severe acne. Methods: In one phase 2 (N=741; NCT03170388) and two identically designed phase 3 (N=183; N=180; NCT04214639; NCT04214652), double-blind, randomized, 12-week studies, participants aged ≥9 years with moderate-to-severe acne were randomized to receive once-daily CAB or vehicle gel; the phase 2 study included three additional dyad randomization arms (data not shown). Coprimary endpoints comprised inflammatory and noninflammatory lesion counts and treatment success (≥2-grade reduction from baseline in Evaluator’s Global Severity Score and score of ‘clear’ or ‘almost clear’). Treatment-emergent adverse events (TEAEs) and cutaneous safety and tolerability were also assessed. Pooled data from these studies were analyzed post hoc from female participants categorized by age: 9-24 years (n=274) and ≥25 years (n=121). Results: At week 12 in both age groups, least-squares mean percent reductions from baseline were >70% in CAB-treated females versus vehicle gel for inflammatory (9-24 y: 77.8% vs 53.8%; ≥25 y: 77.8% vs 60.5%; P<0.01, both) and noninflammatory lesions (9-24 y: 72.8% vs 44.5%; ≥25 y: 73.7% vs 55.2%; P<0.001, both). Half of CAB-treated females in both age groups achieved treatment success at week 12 versus less than one-quarter with vehicle (9-24 y: 54.1% vs 15.6%; ≥25 y: 50.1% vs 22.5%; P<0.01, both). Most TEAEs were mild-to-moderate in severity, with rates similar to the overall pooled phase 2 and 3 populations. Although there were transient increases in the severity of cutaneous safety/tolerability assessments with CAB, scores generally returned to or near baseline levels for most assessments by week 12 in younger and older females. No notable age-related trends in safety were observed. Conclusions: With greater than 70% lesion reductions and half of participants achieving treatment success by week 12, the innovative, fixed-dose triple combination clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel demonstrated good efficacy, safety, and tolerability in both younger and older females with moderate-to-severe acne. Funding: Ortho Dermatologics
导言：痤疮在青少年中很常见，但在成年人中的总体发病率却在不断上升，尤其是女性。此外，老年女性的痤疮对生活质量的负面影响更大。克林霉素磷酸酯 1.2%/阿达帕林 0.15%/过氧化苯甲酰（BPO）3.1%（CAB）凝胶是首个获准用于治疗痤疮的固定剂量三合一外用产品，在中重度痤疮患者中显示出良好的疗效、安全性和耐受性。本分析旨在评估年龄对中重度痤疮女性患者的疗效、安全性和耐受性的影响。研究方法在一项2期研究（N=741；NCT03170388）和两项设计相同的3期研究（N=183；N=180；NCT04214639；NCT04214652）、双盲、随机、为期12周的研究中，年龄≥9岁的中度至重度痤疮患者被随机分配接受每日一次的CAB或载体凝胶；2期研究包括三个额外的双组随机分组（数据未显示）。主要终点包括炎症性和非炎症性皮损计数和治疗成功率（评价者总体严重程度评分和 "痊愈 "或 "基本痊愈 "评分比基线降低≥2级）。此外，还评估了治疗突发不良事件（TEAE）以及皮肤安全性和耐受性。对这些研究的汇总数据进行了事后分析，女性参与者按年龄分为：9-24 岁（274 人）和≥25 岁（121 人）。研究结果第 12 周时，在两个年龄组中，经 CAB 治疗的女性炎症性病变（9-24 岁：77.8% vs 53.8%；≥25 岁：77.8% vs 60.5%；P<0.01，均相同）和非炎症性病变（9-24 岁：72.8% vs 44.5%；≥25 岁：73.7% vs 55.2%；P<0.001，均相同）与药物凝胶相比，最小二乘平均百分比从基线降低了 70% 以上。在两个年龄组中，一半接受过CAB治疗的女性在第12周时取得了治疗成功，而接受药物治疗的女性只有不到四分之一取得了治疗成功（9-24岁：54.1% vs 15.6%；≥25岁：50.1% vs 22.5%；P<0.01，两者均如此）。大多数TEAE的严重程度为轻度至中度，其发生率与第2和第3阶段的总体汇总人群相似。虽然皮肤安全性/耐受性评估的严重程度会随着 CAB 的使用而短暂增加，但在第 12 周之前，年轻女性和老年女性的大多数评估得分普遍恢复到或接近基线水平。在安全性方面没有观察到明显的年龄相关趋势。结论克林霉素磷酸酯1.2%/阿达帕林0.15%/BPO 3.1%凝胶是一种创新的固定剂量三联疗法，在中度至重度痤疮的年轻女性和老年女性中，其皮损减少率超过70%，半数参与者在第12周时取得了治疗成功，显示出良好的疗效、安全性和耐受性。资金来源：Ortho DermatologicsOrtho Dermatologics
{"title":"Efficacy and Safety of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Females with Moderate to Severe Acne: Post Hoc Analysis by Age","authors":"Julie C Harper, L. Stein Gold, Hilary Baldwin, Valerie Callender, Michael Gold, Heather Woolery-Lloyd, L. Kircik","doi":"10.25251/skin.8.supp.392","DOIUrl":"https://doi.org/10.25251/skin.8.supp.392","url":null,"abstract":"Introduction: While acne is common in adolescents, the overall prevalence in adults is increasing, especially among females. In addition, acne in older females is associated with greater negative impacts on quality of life. Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% (CAB) gel—the first fixed-dose, triple-combination topical product approved for acne—has demonstrated good efficacy, safety, and tolerability in participants with moderate-to-severe acne. The objective of this analysis is to assess the impact of age on efficacy, safety, and tolerability in females with moderate-to-severe acne. \u0000Methods: In one phase 2 (N=741; NCT03170388) and two identically designed phase 3 (N=183; N=180; NCT04214639; NCT04214652), double-blind, randomized, 12-week studies, participants aged ≥9 years with moderate-to-severe acne were randomized to receive once-daily CAB or vehicle gel; the phase 2 study included three additional dyad randomization arms (data not shown). Coprimary endpoints comprised inflammatory and noninflammatory lesion counts and treatment success (≥2-grade reduction from baseline in Evaluator’s Global Severity Score and score of ‘clear’ or ‘almost clear’). Treatment-emergent adverse events (TEAEs) and cutaneous safety and tolerability were also assessed. Pooled data from these studies were analyzed post hoc from female participants categorized by age: 9-24 years (n=274) and ≥25 years (n=121). \u0000Results: At week 12 in both age groups, least-squares mean percent reductions from baseline were >70% in CAB-treated females versus vehicle gel for inflammatory (9-24 y: 77.8% vs 53.8%; ≥25 y: 77.8% vs 60.5%; P<0.01, both) and noninflammatory lesions (9-24 y: 72.8% vs 44.5%; ≥25 y: 73.7% vs 55.2%; P<0.001, both). Half of CAB-treated females in both age groups achieved treatment success at week 12 versus less than one-quarter with vehicle (9-24 y: 54.1% vs 15.6%; ≥25 y: 50.1% vs 22.5%; P<0.01, both). Most TEAEs were mild-to-moderate in severity, with rates similar to the overall pooled phase 2 and 3 populations. Although there were transient increases in the severity of cutaneous safety/tolerability assessments with CAB, scores generally returned to or near baseline levels for most assessments by week 12 in younger and older females. No notable age-related trends in safety were observed. \u0000Conclusions: With greater than 70% lesion reductions and half of participants achieving treatment success by week 12, the innovative, fixed-dose triple combination clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel demonstrated good efficacy, safety, and tolerability in both younger and older females with moderate-to-severe acne. \u0000Funding: Ortho Dermatologics","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140231433","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-18DOI: 10.25251/skin.8.supp.381
Raj Chovatiya, Aseel Bin Sawad, Janine Fournier, Donna Fountain, Caroline Shaw, Jasmine Toomey, Mariola Vazquez, A. Tallman, Doral Fredericks
Introduction: Complete skin clearance is a key atopic dermatitis (AD) treatment goal. Treatment efficacy in AD trials is evaluated using a range of clinical measures with the Investigator’s Global Assessment (IGA) as a key endpoint. Multiple and varied forms of the IGA scale are utilized across trials, including the Investigator’s Static Global Assessment and the Validated Investigator Global Assessment for ADTM. IGA scores usually range from 0 (clear) to 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe), but contain differences in detail assessed. Efficacy endpoints using IGA scales include achieving IGA=0 or 1 with ≥2-point improvement from baseline, or IGA=0. The Eczema Area and Severity Index (EASI) and achievement of ≥75% or ≥90% improvement from baseline (EASI75 and EASI90) are additional gold-standard measurements. Objective: To compare differences in efficacy outcomes in recent clinical trials of FDA-approved AD treatments for adults and children. Methods: A systematic literature search was conducted using MEDLINE, Embase, Cochrane Library, and hand search to identify AD trials published in English language between January 1, 2016 and August 16, 2023. Trials could include patients with any severity of AD who were treated with topical therapies (crisaborole, ruxolitinib), injectable systemics (dupilumab, tralokinumab), or oral systemics (upadacitinib, abrocitinib) according to approved indications. Efficacy outcomes of IGA=0 or 1 with ≥2-point improvement, IGA=0, EASI75, and EASI90 were categorized and summarized by AD severity, treatment type, and age groups in the trials. Results: Of 50 publications identified, 40 (80%) reported randomized controlled trials, 2 (4%) single-arm trials, and 8 (16%) open-label extension trials. By patient age groups, 11 publications were on children (<12 years), 8 on adolescents (12–17 years),15 on patients ≥12 years, and 17 on adults (≥18 years). Moderate to severe AD was the most frequently studied severity (38/50 publications), of which all trials were either as systemic monotherapy or systemic therapy combined with a topical. Topical monotherapy for mild to moderate AD only was reported in 8/50 publications. For topicals, achievement of IGA=0 (clear) was not reported for any age group, and no trials reported EASI90 for children <12 years. For injectable systemics, no outcome was reported for IGA=0 (clear) in children <12 years. For oral systemics, no outcomes were reported for children <12 years. Conclusions: This literature search of AD trial publications on FDA-approved treatments from 2016 onwards revealed several gaps in available outcomes data. There were no trials that assessed a topical therapy for moderate to severe AD, and complete disease clearance (IGA=0) was not demonstrated for any topicals. The findings reinforce the unmet need for a topical AD treatment that can provide high efficacy including complete clearance without restriction based on age or disease severity. Funding Supp
{"title":"Efficacy Outcomes in Clinical Trials of Atopic Dermatitis Treatments: A Systematic Literature Review","authors":"Raj Chovatiya, Aseel Bin Sawad, Janine Fournier, Donna Fountain, Caroline Shaw, Jasmine Toomey, Mariola Vazquez, A. Tallman, Doral Fredericks","doi":"10.25251/skin.8.supp.381","DOIUrl":"https://doi.org/10.25251/skin.8.supp.381","url":null,"abstract":"Introduction: Complete skin clearance is a key atopic dermatitis (AD) treatment goal. Treatment efficacy in AD trials is evaluated using a range of clinical measures with the Investigator’s Global Assessment (IGA) as a key endpoint. Multiple and varied forms of the IGA scale are utilized across trials, including the Investigator’s Static Global Assessment and the Validated Investigator Global Assessment for ADTM. IGA scores usually range from 0 (clear) to 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe), but contain differences in detail assessed. Efficacy endpoints using IGA scales include achieving IGA=0 or 1 with ≥2-point improvement from baseline, or IGA=0. The Eczema Area and Severity Index (EASI) and achievement of ≥75% or ≥90% improvement from baseline (EASI75 and EASI90) are additional gold-standard measurements. \u0000Objective: To compare differences in efficacy outcomes in recent clinical trials of FDA-approved AD treatments for adults and children. \u0000Methods: A systematic literature search was conducted using MEDLINE, Embase, Cochrane Library, and hand search to identify AD trials published in English language between January 1, 2016 and August 16, 2023. Trials could include patients with any severity of AD who were treated with topical therapies (crisaborole, ruxolitinib), injectable systemics (dupilumab, tralokinumab), or oral systemics (upadacitinib, abrocitinib) according to approved indications. Efficacy outcomes of IGA=0 or 1 with ≥2-point improvement, IGA=0, EASI75, and EASI90 were categorized and summarized by AD severity, treatment type, and age groups in the trials. \u0000Results: Of 50 publications identified, 40 (80%) reported randomized controlled trials, 2 (4%) single-arm trials, and 8 (16%) open-label extension trials. By patient age groups, 11 publications were on children (<12 years), 8 on adolescents (12–17 years),15 on patients ≥12 years, and 17 on adults (≥18 years). Moderate to severe AD was the most frequently studied severity (38/50 publications), of which all trials were either as systemic monotherapy or systemic therapy combined with a topical. Topical monotherapy for mild to moderate AD only was reported in 8/50 publications. For topicals, achievement of IGA=0 (clear) was not reported for any age group, and no trials reported EASI90 for children <12 years. For injectable systemics, no outcome was reported for IGA=0 (clear) in children <12 years. For oral systemics, no outcomes were reported for children <12 years. \u0000Conclusions: This literature search of AD trial publications on FDA-approved treatments from 2016 onwards revealed several gaps in available outcomes data. There were no trials that assessed a topical therapy for moderate to severe AD, and complete disease clearance (IGA=0) was not demonstrated for any topicals. The findings reinforce the unmet need for a topical AD treatment that can provide high efficacy including complete clearance without restriction based on age or disease severity. \u0000Funding Supp","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140231622","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-18DOI: 10.25251/skin.8.supp.378
Jacob Thyssen, Jonathan I. Silverberg, Andrew Blauvelt, Paolo Criado, Walter Gubelin, Juan Ruano Ruiz, Ricardo Rojo, Ketti Terry, Hernan Valdez, Pinaki Biswas, Claire Feeney
Introduction: JADE REGIMEN (NCT03627767) was conducted to evaluate the feasibility of continual, reduced dose or withdrawal of abrocitinib after induction of response in patients with moderate-to-severe atopic dermatitis (AD). This post hoc analysis evaluated patient factors associated with a higher probability of persistent clinical response with abrocitinib, without flare, during a 40-week maintenance period.Methods: Data were analyzed from patients who responded to abrocitinib 200 mg induction therapy (12 weeks) and were randomly assigned to receive abrocitinib (200 or 100 mg) or placebo in the maintenance period (40 weeks). A multivariable logistic regression model with fixed and random effects was fit to determine factors associated with not experiencing flare by week 52. Fixed effects (factors) considered were randomly allocated treatment, age (<18 vs ≥18 years), race, weight, prior use of systemic agents, AD duration, onset of response in induction (early vs late), Investigator’s Global Assessment score at randomization, body surface area (BSA, ≤50% vs >50%) at baseline, and percentage change in Eczema Area and Severity Index (EASI) at randomization. Backward elimination and stepwise model selection procedures were applied with entry and exit criteria based on a P value threshold of 5%.Results:1233 patients received abrocitinib 200 mg in the induction period. By week 12, 798 (64.7%) achieved a response and were randomly assigned to receive maintenance treatment for 40 weeks. In total, 356 patients (44.6%) experienced a protocol-defined flare: 16.5% (200 mg), 39.6% (100 mg), and 77.5% (placebo). After model selection, the analysis identified continuation of treatment with abrocitinib 200 mg (odds ratio [OR], 19.51; 95% CI, 11.28-33.75) or reduced-dose abrocitinib 100 mg (5.27; 3.29-8.46) as the greatest predictors of not experiencing flare during maintenance. Not having previously used systemic agents (OR, 1.53; 95% CI, 1.09-2.14), lower baseline BSA (1.55; 1.10-2.17), and greater percentage reduction of EASI during induction (1.35; 1.15-1.59) were also associated with not experiencing flare.Conclusions: Multivariable analysis of JADE REGIMEN indicated that maintenance treatment with abrocitinib in patients with AD reduced the risk for flare in a dose-dependent manner. Other factors associated with maintaining response to treatment without flare included no previous exposure to systemic agents, lower extent of BSA involvement at baseline, and greater percent change in EASI during induction. These findings may assist clinicians with abrocitinib dosing decisions in the future.
{"title":"Factors Associated with Persistent Efficacy of Abrocitinib without Flare: A Multivariable Analysis of the JADE-REGIMEN Study","authors":"Jacob Thyssen, Jonathan I. Silverberg, Andrew Blauvelt, Paolo Criado, Walter Gubelin, Juan Ruano Ruiz, Ricardo Rojo, Ketti Terry, Hernan Valdez, Pinaki Biswas, Claire Feeney","doi":"10.25251/skin.8.supp.378","DOIUrl":"https://doi.org/10.25251/skin.8.supp.378","url":null,"abstract":"Introduction: JADE REGIMEN (NCT03627767) was conducted to evaluate the feasibility of continual, reduced dose or withdrawal of abrocitinib after induction of response in patients with moderate-to-severe atopic dermatitis (AD). This post hoc analysis evaluated patient factors associated with a higher probability of persistent clinical response with abrocitinib, without flare, during a 40-week maintenance period.Methods: Data were analyzed from patients who responded to abrocitinib 200 mg induction therapy (12 weeks) and were randomly assigned to receive abrocitinib (200 or 100 mg) or placebo in the maintenance period (40 weeks). A multivariable logistic regression model with fixed and random effects was fit to determine factors associated with not experiencing flare by week 52. Fixed effects (factors) considered were randomly allocated treatment, age (<18 vs ≥18 years), race, weight, prior use of systemic agents, AD duration, onset of response in induction (early vs late), Investigator’s Global Assessment score at randomization, body surface area (BSA, ≤50% vs >50%) at baseline, and percentage change in Eczema Area and Severity Index (EASI) at randomization. Backward elimination and stepwise model selection procedures were applied with entry and exit criteria based on a P value threshold of 5%.Results:1233 patients received abrocitinib 200 mg in the induction period. By week 12, 798 (64.7%) achieved a response and were randomly assigned to receive maintenance treatment for 40 weeks. In total, 356 patients (44.6%) experienced a protocol-defined flare: 16.5% (200 mg), 39.6% (100 mg), and 77.5% (placebo). After model selection, the analysis identified continuation of treatment with abrocitinib 200 mg (odds ratio [OR], 19.51; 95% CI, 11.28-33.75) or reduced-dose abrocitinib 100 mg (5.27; 3.29-8.46) as the greatest predictors of not experiencing flare during maintenance. Not having previously used systemic agents (OR, 1.53; 95% CI, 1.09-2.14), lower baseline BSA (1.55; 1.10-2.17), and greater percentage reduction of EASI during induction (1.35; 1.15-1.59) were also associated with not experiencing flare.Conclusions: Multivariable analysis of JADE REGIMEN indicated that maintenance treatment with abrocitinib in patients with AD reduced the risk for flare in a dose-dependent manner. Other factors associated with maintaining response to treatment without flare included no previous exposure to systemic agents, lower extent of BSA involvement at baseline, and greater percent change in EASI during induction. These findings may assist clinicians with abrocitinib dosing decisions in the future.","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140231708","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-18DOI: 10.25251/skin.8.supp.398
Brenda Edison, Li Feng, Surabhi Singh, Ritamarie Guerrero, Ramine Parsa, Ruchi Patel, Marisa Dufort, Barbara Green
Besides fine lines and wrinkles, chronological aging leads to discoloration, age spots, and more importantly, sagging and loss of elasticity on facial skin. There are ample consumer needs to reduce age spots and skin sagging with an increasing desire for effective topical solutions that can provide meaningful benefits in these areas. A new microdipeptide (acetyl dipeptide) technology was developed that demonstrated the potential to reduce skin inflammation and stimulate the skin’s supporting matrix. This clinical study was designed to test the effectiveness of a facial cream with a unique blend of microdipeptide technology along with brightening and firming ingredients to reduce the key signs of facial aging with twice daily use. The 16-week study included 43 healthy female subjects, ages 40-70 with diverse skin tones, and having mild to moderate jawline sagging with fine lines and/or hyperpigmentation by expert visual grading (3 to 6 on a 0 to 9 scale). Visual grading exhibited statistically significant reduction in all targeted skin aging signs starting at week 8, and continuing improvement to week 16, including jawline sagging (19%), laxity (19%), lift/ firmness (15%), as well as improved evenness of skin tone (16%), hyperpigmentation (14%) and overall photodamage (23%) (mean percent change, p< 0.05). Consumer perception questionnaires also revealed improvement after 16 weeks of use with tighter/tauter jawlines (88%), increased firmness (93%), skin elasticity (93%), refined facial contour (88%), less sagging (95%), and more lifted (91%) and volumized appearance (98%). Furthermore, subjects also indicated brighter skin (95%), increased radiance (93%), less discoloration (86%), fading dark spots (77%), reduced fine lines (93%) and wrinkles (95%), skin looks younger (95%), and overall less noticeable aging signs (95%). Clinical photography supported both the clinical grading and consumer perception of benefits. In addition, these clinical outcomes are further supported by in vitro and ex vivo investigations showing the microdipeptide activity on inhibiting the expression of inflammatory cytokines and inducing multiple matrix building biomarkers, beyond elastin, pro-collagen and hyaluronic acid to include decorin and fibronectin. Gene expression profiling showed changes associated with skin barrier and extracellular matrix organizations, therefore mimicking a younger-looking skin. These results demonstrated that this peptide facial cream was well-tolerated and effective in improving jawline sagging, facial skin firmness, skin brightening, and reducing the overall signs of aging.
{"title":"A New Peptide Skin-Brightening Facial Cream Demonstrated Clinical Improvement in Jawline Sagging, Discoloration and Overall Photodamage","authors":"Brenda Edison, Li Feng, Surabhi Singh, Ritamarie Guerrero, Ramine Parsa, Ruchi Patel, Marisa Dufort, Barbara Green","doi":"10.25251/skin.8.supp.398","DOIUrl":"https://doi.org/10.25251/skin.8.supp.398","url":null,"abstract":"Besides fine lines and wrinkles, chronological aging leads to discoloration, age spots, and more importantly, sagging and loss of elasticity on facial skin. There are ample consumer needs to reduce age spots and skin sagging with an increasing desire for effective topical solutions that can provide meaningful benefits in these areas. A new microdipeptide (acetyl dipeptide) technology was developed that demonstrated the potential to reduce skin inflammation and stimulate the skin’s supporting matrix. This clinical study was designed to test the effectiveness of a facial cream with a unique blend of microdipeptide technology along with brightening and firming ingredients to reduce the key signs of facial aging with twice daily use. The 16-week study included 43 healthy female subjects, ages 40-70 with diverse skin tones, and having mild to moderate jawline sagging with fine lines and/or hyperpigmentation by expert visual grading (3 to 6 on a 0 to 9 scale). Visual grading exhibited statistically significant reduction in all targeted skin aging signs starting at week 8, and continuing improvement to week 16, including jawline sagging (19%), laxity (19%), lift/ firmness (15%), as well as improved evenness of skin tone (16%), hyperpigmentation (14%) and overall photodamage (23%) (mean percent change, p< 0.05). Consumer perception questionnaires also revealed improvement after 16 weeks of use with tighter/tauter jawlines (88%), increased firmness (93%), skin elasticity (93%), refined facial contour (88%), less sagging (95%), and more lifted (91%) and volumized appearance (98%). Furthermore, subjects also indicated brighter skin (95%), increased radiance (93%), less discoloration (86%), fading dark spots (77%), reduced fine lines (93%) and wrinkles (95%), skin looks younger (95%), and overall less noticeable aging signs (95%). Clinical photography supported both the clinical grading and consumer perception of benefits. In addition, these clinical outcomes are further supported by in vitro and ex vivo investigations showing the microdipeptide activity on inhibiting the expression of inflammatory cytokines and inducing multiple matrix building biomarkers, beyond elastin, pro-collagen and hyaluronic acid to include decorin and fibronectin. Gene expression profiling showed changes associated with skin barrier and extracellular matrix organizations, therefore mimicking a younger-looking skin. These results demonstrated that this peptide facial cream was well-tolerated and effective in improving jawline sagging, facial skin firmness, skin brightening, and reducing the overall signs of aging.","PeriodicalId":22013,"journal":{"name":"SKIN The Journal of Cutaneous Medicine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140232314","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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