Dermatology and Therapy最新文献

Introduction: Melasma is a common acquired disorder of melanogenesis that predominately affects women and presents as hyperpigmented skin lesions mainly located on the face. The study aims to investigate the epidemiologic characteristics and hormonal profiles in melasma patients.

Methods: One hundred fifty patients were enrolled in this study in a tertiary care hospital. Clinical patterns, pigment depth, disease severity, underlying conditions, and heredity were recorded. Endocrinologic profile and vitamin D levels were assessed.

Results: On clinical examination, the condition indicated a centrofacial localization in 74% of the patients. Extra facial melasma was noticed in 10 patients who had centrofacial melasma to begin with. Wood's lamp examination showed the dermal type as the most common. A family history of melasma was noted in 38% of the patients. Melasma Area and Severity Index (MASI) score ranged from 0.3 to 10.8, with a mean score of 4.12 ± 2.06. Pregnancy-induced melasma was reported in 36.1% of the patients. In 17.4% of women, melasma was related to using oral contraceptives. In 22% of patients, mild vitamin D deficiency was detected, while 21% had thyroid disorders.

Conclusion: There is a strong correlation between family history and prevalence of melasma. Sun exposure is a major precipitating factor and should be carefully addressed in Mediterranean countries like Greece. However, other factors such as concomitant medication, multiple pregnancies, use of oral contraceptives, thyroid disorders and vitamin D deficiency might precipitate melasma.

Introduction: Acne is the most frequent chronic inflammatory skin condition in adolescence but occurs also in later age. Our study aimed to characterise the epidemiology, geographical distribution, comorbidity and healthcare of acne juvenilis (AJ) and acne tarda (AT).

Methods: Statutory health insurance (SHI) data from 2016 to 2020 were analysed. Prevalence rates, including geographical distribution, comorbidities and drug use by specialists group, were measured.

Results: In 2020, the prevalence of acne among adults was 1.50% (AT > 25 years) and among adolescents was 3.88% (AT ≤ 25 years). The highest prevalence (13.02%) was observed at the age of 17 years. Sex differences were higher in AT (73.80% in women) than in AJ (64.55% in women). Compared with non-affected persons, individuals with acne - in particular with AT - showed significantly higher rates of skin-related comorbidities, including folliculitis (rate ratio (RR) 8.89), pyoderma (RR 7.27) and rosacea (RR 5.53), and non-skin-related comorbidities, such as ovarian dysfunction (RR 2.36), rhinitis allergica (RR 1.84) and Crohn's disease (RR 1.79). Preferred systemic therapeutics prescribed were anti-infectives in AT (46.86%) and retinoids in AJ (52.35%). In the majority of cases, dermatologists were involved in the treatment of acne (AT 65.77%; AJ 76.27%). The most commonly prescribed topical agents were adapalene with benzoyl peroxide (AT 87.72%; AJ 85.75%), while systemic isotretinoin (AT 81.20%; AJ 90.06%) was also a frequently used drug. General practitioners were more likely to prescribe anti-infectives, especially topical antibiotics such as chlortetracycline (AT 52.38%; AJ 44.44%) and systemic antibiotics, especially tetracycline (AT 58.33%; AJ 67.50%).

Conclusion: Acne affects a relevant proportion of the German population not only in adolescence, and management of this inflammatory skin disease does not naturally follow medical guidelines or specialist recommendations. These findings emphasise the importance of specialised care and comprehensive therapeutic management that should also consider the exploration of comorbidities.

Introduction: Acne is a one of the most frequent skin conditions among teenagers and young adults. It is currently managed with topical retinoids and antibiotics, which can present numerous side effects, thus reducing treatment adherence and effectiveness. We evaluated the efficacy and tolerability of a novel dermo-cosmetic cream (α-AZ) in treating mild to moderate acne.

Methods: Subjects were randomized into three groups: group 1 received α-AZ cream, group 2 was treated with α-AZ combined with an oral acne treatment routine, and group 3 received a topical acne treatment, for 84 days. All treated patients underwent a 28-day maintenance period with α-AZ cream. Total acne and post-inflammatory hyperpigmentation (PIH) scoring, quality of life (QoL), and skin tolerance were all evaluated during the treatment and maintenance periods.

Results: Acne and PIH lesions significantly decreased in group 1 compared to group 3 (p < 0.001), with a reduction in acne of 66.52 ± 2.92% in group 1 versus 52.55 ± 3.90% in group 3. Patients in group 1 achieved nearly clear skin by the end of the treatment. α-AZ cream treatment was well tolerated and all participants experienced an enhanced QoL. Participants expressed high satisfaction. Additional enhancements in all groups were noted during the maintenance phase across all clinical parameters.

Conclusion: The novel dermo-cosmetic α-AZ cream could serve as a valuable new approach to current treatments for mild and moderate acne. It can be used alone, as a once-daily adjuvant to oral acne treatments, or as part of a maintenance regimen.

Trial registration: ISRCTN registry, ISRCTN70142596, registered retrospectively on 11/12/2023.

Introduction: There is an unmet need for effective topical therapies for patients with uremic xerosis and chronic kidney disease-associated pruritus (CKD-aP). The long-term efficacy and tolerability of an emollient containing glycerol 15% and paraffin 10% (V0034CR) was evaluated in a phase 3 study.

Methods: In this randomized, double-blind, two-parallel group, vehicle-controlled study, patients with moderate-to-severe uremic xerosis were randomized to once-daily application of V0034CR or vehicle control for 28 days (period I). This was followed by a treatment-free period of ≤ 21 days (period II), then all patients received open-label treatment with V0034CR for ≥ 84 days (period III). Outcomes included treatment response at the end of period I (El Gammal's xerosis severity score), instrumental measures of scaling (D-Squame technique), time to relapse during period II, rate of recurrence during period III, pruritus severity over time, patient acceptability, and adverse events (AEs).

Results: The intent-to-treat population comprised 235 patients randomized to V0034CR (n = 118) or vehicle control (n = 117) during period I. Treatment response at the end of period I was achieved by 71 patients (60.2%) in the V0034CR group versus 48 (41.0%) with vehicle control (p = 0.0041). This coincided with greater reductions in the total surface area of squames (p = 0.001 vs vehicle control). Xerosis relapsed progressively without treatment in period II; however, remission was durable under maintenance therapy in period III. Improvements in pruritus severity were comparable between V0034CR and vehicle control, suggesting that the antipruritic effect of V0034CR was mainly exerted by its oil-in-water emulsion base. V0034CR had high patient acceptability and was well tolerated; the most common treatment-related AEs were irritation or erythema (2.1%), exacerbated pruritus (1.3%), and vesicles at the application site (0.9%).

Conclusion: These data support the use of V0034CR, with its hydrating and occlusive properties, for the long-term management of patients with moderate-to-severe uremic xerosis and CKD-aP.

Trial registration: ClinicalTrials.gov identifier NCT01084148; EudraCT number 2006-002201-31.

Introduction: Chronic Hand Eczema (CHE) is an inflammatory skin disease that causes significant impact on health-related quality of life (HRQoL). The Hand Eczema Impact Scale (HEIS) is a new patient-reported outcome (PRO) measure designed to assess the impact of CHE on key domains of HRQoL. This study aimed to develop and evaluate content and psychometric validity of the HEIS.

Methods: The HEIS was initially developed on the basis of a literature review and concept elicitation interviews. Qualitative cognitive debriefing interviews (n = 20) were conducted with patients with CHE to assess relevance and understanding of items, response options, and recall period. Psychometric properties (item performance, dimensionality, reliability, validity, responsiveness, and estimation of meaningful change thresholds) were then assessed using data (n = 258) from a phase 2b trial (NCT03683719).

Results: Cognitive debriefing confirmed all items were understood and relevant to patients. Inter-item correlations (all > 0.50) and confirmatory factor analysis (factor loadings ≥ 0.80) supported unidimensionality of the HEIS score, and mostly provided support for the HEIS Proximal Daily Activity Limitations (PDAL) score, with only one item loading below the prespecified threshold. Item properties and previous qualitative work supported retaining this item in the total score but removed from the HEIS PDAL domain. Internal consistency (Cronbach's alpha ≥ 0.89) and test-retest reliability (intra-class correlation coefficient ≥ 0.79) results were very strong. Strong correlations with concurrent measures (0.66-0.87) and significant differences between severity groups (p < 0.001) supported construct validity. Large effect sizes for mean change scores in participants that improved and significant differences between groups indicated ability to detect change. Anchor-based analyses supported within-individual responder definitions of ≥ 1.3 points for improvements in both HEIS score and HEIS PDAL score (covering three items) and of ≥ 1.5 points for HEIS embarrassment with the appearance of hands (Emb) score (covering two items).

Conclusions: The 9-item HEIS is the first CHE-specific PRO measure developed and validated according to regulatory guidance for assessment of the impact of CHE on key domains of HRQoL. This article provides evidence of strong content and psychometric validity and shows improvements of ≥ 1.3 points in HEIS score and HEIS PDAL score, and improvements of ≥ 1.5 points in HEIS Emb score represent clinically meaningful, important changes.

Trial registration: NCT03683719.

Introduction: Despite advancements in the treatment of psoriasis (PsO), there are few head-to-head studies assessing comparative effectiveness of the newest therapies approved to treat PsO. Our objective was to assess the comparative clinical effectiveness of risankizumab and deucravacitinib in patients with moderate-to-severe PsO.

Methods: This placebo-anchored matching-adjusted indirect comparison (MAIC) analysis utilized data from UltIMMa-1/2 risankizumab and POETYK PSO-1/2 deucravacitinib trials. Individual patient data from UltiMMA-1/2 were weighted via propensity score to match POETYK PSO-1/2 published summary data. Rate differences between risankizumab and deucravacitinib were assessed for Psoriasis Area and Severity Index (PASI) 75/90/100, the Static Physician Global Assessment (sPGA = 0 or 0/1), and the Dermatology Life Quality Index (DLQI) 0/1.

Results: At 16 weeks, risankizumab-treated patients demonstrated statistically significantly higher rates of skin clearance and greater improvement in quality of life (QoL) compared to those treated with deucravacitinib. Across all outcomes, risankizumab demonstrated a lower number needed to treat compared to deucravacitinib. Limitations are potential bias due to unobserved/unmeasurable differences and limited generalizability of the results.

Conclusions: This indirect comparison demonstrates that risankizumab has higher rates of skin clearance and greater improvements in QoL than deucravacitinib. This study will help inform healthcare providers in their treatment and management strategy of PsO.

Introduction: Guselkumab, a human monoclonal antibody targeting the p19 subunit of interleukin-23 (IL-23), has shown efficacy in psoriasis and psoriatic arthritis. However, long-term real-world data on its effectiveness in patients with inadequate response to ustekinumab are limited. This study investigates guselkumab's long-term effectiveness and safety in patients with psoriasis with partial response to ustekinumab.

Methods: We performed a retrospective multicentric study analyzing data of patients with psoriasis from seven Italian hospitals between January 2021 and May 2024. The study included 169 patients who switched from ustekinumab to guselkumab. Primary endpoints were Psoriasis Area and Severity Index (PASI) 75, PASI 90, PASI 100, and absolute PASI ≤ 2. Site-specific Physician Global Assessment (PGA) scores were also collected for difficult-to-treat areas.

Results: The study included 169 patients. After 3 years of treatment, PASI 75, PASI 90 and PASI 100 were achieved by 88.4%, 55.8%, and 32.6% of patients, respectively. Site-specific PGA showed significant improvements, especially in the scalp and genital areas. After 3 years of treatment, no significant impact of higher body mass index (BMI) or cardiometabolic comorbidities on guselkumab effectiveness was detected. No severe adverse events were reported during the study period.

Conclusions: In our study, guselkumab provided significant long-term effectiveness and safety in patients partially responsive to ustekinumab, improving both PASI score and site-specific PGA and confirming its potential use for patients with psoriasis switching from ustekinumab.

Introduction: Alopecia areata (AA) is an autoimmune disease causing non-scarring hair loss, with both genetic and environmental factors implicated. Recent research highlights a possible role for scalp microbiota in influencing both local and systemic inflammatory responses, potentially impacting AA progression. This study examines the link among scalp microbiota imbalances, AA severity, and systemic inflammation.

Methods: We conducted a cross-sectional study with 24 participants, including patients with AA of varying severities and healthy controls. Scalp microbial communities were analyzed using swab samples and ion torrent sequencing of the 16S rRNA gene across multiple hypervariable regions. We explored correlations among bacterial abundance, microbiome metabolic pathways, and circulating inflammatory markers.

Results: Our findings reveal significant dysbiosis in the scalp microbiota of patients with AA compared to healthy controls. Severe AA cases had an increased presence of pro-inflammatory microbial taxa like Proteobacteria, whereas milder cases had higher levels of anti-inflammatory Actinobacteria. Notable species differences included abundant gram-negative bacteria such as Alistipes inops and Bacteroides pleibeius in severe AA, contrasted with Blautia faecis and Pyramydobacter piscolens predominantly in controls. Significantly, microbial imbalance correlated with AA severity (SALT scores) and systemic inflammatory markers, with elevated pro-inflammatory cytokines linked to more severe disease.

Conclusion: These results suggest that scalp microbiota may play a role in AA-related inflammation, although it is unclear whether the shifts are a cause or consequence of hair loss. Further research is needed to clarify the causal relationship and mechanisms involved.

Introduction: Developing automatic acne vulgaris grading systems based on machine learning is an expensive endeavor in terms of data acquisition. A machine learning practitioner will need to gather high-resolution pictures from a considerable number of different patients, with a well-balanced distribution between acne severity grades and potentially very tedious labeling. We developed a deep learning model to grade acne severity with respect to the Investigator's Global Assessment (IGA) scale that can be trained on low-resolution images, with pictures from a small number of different patients, a strongly imbalanced severity grade distribution and minimal labeling.

Methods: A total of 1374 triplets of images (frontal and lateral views) from 391 different patients suffering from acne labeled with the IGA severity grade by an expert dermatologist were used to train and validate a deep learning model that predicts the IGA severity grade.

Results: On the test set we obtained 66.67% accuracy with an equivalent performance for all grades despite the highly imbalanced severity grade distribution of our database. Importantly, we obtained performance on par with more tedious methods in terms of data acquisition which have the same simple labeling as ours but require either a more balanced severity grade distribution or large numbers of high-resolution images.

Conclusions: Our deep learning model demonstrated promising accuracy despite the limited data set on which it was trained, indicating its potential for further development both as an assistance tool for medical practitioners and as a way to provide patients with an immediately available and standardized acne grading tool.

Trial registration: chinadrugtrials.org.cn identifier CTR20211314.