Journal of Drugs in Dermatology最新文献

Background: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are increasingly prescribed for conditions beyond type 2 diabetes, including psoriasis and hidradenitis suppurativa. Despite this, little is known about their dermatologic safety profiles.

Methods: We analyzed FDA Adverse Event Reporting System (FAERS) data from 2018 to 2024 for semaglutide, liraglutide, exenatide, and dulaglutide. Cutaneous adverse events (AEs) were identified using MedDRA-coded terms: "rash," "pruritus," "urticaria," "alopecia," and "angioedema". Frequency and proportional reporting ratios (PRRs) were calculated using dipeptidyl peptidase-4 (DPP-4) inhibitors as a comparator. Logistic regression assessed predictors of cutaneous AEs, with dulaglutide as a reference and sex, age, and GLP-1 RA type as independent variables.

Results: Cutaneous AEs were reported in up to 8.16% of GLP-1 RA cases, more often in females, with a mean patient age of 60. Semaglutide was associated with the highest rate, and dulaglutide the lowest. PRR analysis (0.27; 95% CI: 0.257-0.284) showed these AEs were proportionally less common relative to DPP-4 inhibitor users. Exenatide was associated with increased odds (OR = 5.01, 95% CI: 4.69–5.35), while liraglutide and semaglutide showed decreased odds.

Discussion: Possibly influenced by dosage, immune modulation, and patient perception of efficacy, cutaneous GLP-1RA adverse effects were less frequent than DPP-4 inhibitors, but still warrant clinician awareness. These reactions might impact patient adherence, which highlights the need for further investigation into their mechanisms.

Conclusion: Cutaneous AEs are infrequent but vary by GLP-1 RA. Greater awareness may improve patient counseling as indications expand.  .

Background: A new multimodal skin tone correcting serum formulated with b.r.y.t.e.r. (brown, red, and yellow tones with enhanced resurfacing) technology (EV-I) targets brown, red, and yellow dyschromia and acts through 5 pathways of melanin synthesis to reduce pigmentation, resurface and exfoliate skin, and improve overall skin tone.

Methods: A single-center, open-label, 12-week trial enrolled females with mild-to-severe dyschromia/hyperpigmentation. EV-I was applied twice daily for 12 weeks, with a subset of participants also applying a double-conjugated retinoid/AHA cream (AHARet) nightly. Pigmentation was graded using the Melasma Area and Severity Index (MASI) scale at baseline and at weeks 2, 4, 8, and 12. Skin dullness and texture were assessed using a 6-point grading scale. Erythema and dryness/flaking were assessed using a 4-point grading scale. Participant satisfaction and adverse events (AEs) were collected over 12 weeks.

Results: Sixty-five participants were enrolled (EV-I, n=40; EV-I/AHARet, n=25) with a mean age of 53 years; 78% of participants had Fitzpatrick skin types (FST) I-III, 22% were FST IV-VI. The majority of participants presented with moderate-to-severe dyschromia/hyperpigmentation. Significant percent improvements from baseline were demonstrated based on MASI scores at 12 weeks (EV-I, 42%, EV-I/AHARet, 47% [all, P<.0001]). Significant improvements from baseline were demonstrated in the appearance of skin texture (EV-I, 46%; EV-I/AHARet, 59% [all, P<.0001]) and dullness (EV-I, 47%; EV-I/AHARet, 59% [all, P<.0001]) at 12 weeks. No increases in erythema or dryness/flaking were observed.

Conclusions: A new multimodal skin tone correcting serum demonstrated significant improvements in MASI scores and in the appearance of skin texture and dullness. Significant improvements were also achieved in participants using both the skin tone correcting serum and double-conjugated retinoid/AHA cream. Participants reported high levels of satisfaction over 12 weeks.  .

Background: Sunless tanners offer a safer alternative to ultraviolet (UV)-based tanning but may cause adverse skin reactions, including irritant and allergic contact dermatitis. This study examines the composition, efficacy, safety, and reported side effects of commonly used sunless tanning products.

Methods: The top 50 sunless tanners on Amazon's Best Sellers list (March 2025) were reviewed. After excluding bundles, applicators, and non-self-tanning cosmetics, 37 products were included. Ingredient lists were analyzed, and customer reviews were screened for reports of skin reactions using predefined keywords.

Results: All products contained dihydroxyacetone (DHA), 38% included erythrulose, 11% contained melanin, and 5% included tyrosine derivatives. Only one product (3%) also contained sunscreen. On average, 1.96% of customer reviews mentioned skin reactions.

Discussion: DHA remains the predominant active ingredient, with erythrulose, melanin, and tyrosine derivatives used less frequently. Emerging or less common agents such as troxerutin, melanotan, and melanoidins raise safety and regulatory concerns. Reported adverse effects include contact dermatitis and pigmentary changes, which may complicate dermatologic assessments.

Conclusion: While sunless tanners provide a UV-free tanning option, dermatologists should educate patients on ingredient safety, potential adverse effects, and proper application techniques. Given their minimal UV protection, patients should be advised to continue regular sunscreen use.

Background: Previous studies have documented the capacity of malassezin to brighten the skin. It represents a novel agent for the treatment of hyperpigmentation.

Objective: To compare the efficacy and safety of a topical 0.75% malassezin formulation to 4% hydroquinone, the gold standard for treating melasma.

Methods: A randomized, controlled, split-face, double-blind study was conducted in 20 adult female subjects with symmetrical mild-to-moderate melasma. Subjects were randomized 1:1 to determine the allotted side of the face treated twice per day with malassezin or hydroquinone for 12 weeks. Treatment efficacy was evaluated by measuring brightening effects, global improvement, split-face Melasma Area Severity Index (hemi-MASI) scores, colorimetry measurements, and photography.

Results: Twenty subjects completed the study. Compared to baseline, both malassezin and hydroquinone-treated facial areas showed significant efficacy at 12 weeks in brightening (1.85 and 1.95, P=0.027 and 0.008); global improvement (2.2 and 2.3, P=0.004 and 0.001); and hemi-MASI reduction (2.49 and 2.33; P<0.001 and P<0.001), respectively. However, there were no statistically significant differences when comparing the malassezin-treated side to the hydroquinone-treated side at each visit. Side effects in both groups were mild throughout the study.

Conclusion: These findings suggest that malassezin shows comparable efficacy to the gold standard, hydroquinone. Our results further support malassezin as a promising new treatment for patients with melasma.  .

A 73-year-old woman with Fitzpatrick skin type V presented with a long-standing brownish-black, three-tone macule on the right anterior thigh that developed a sharply demarcated depigmented halo. She also exhibited depigmented patches on the buttocks, hands, and feet consistent with vitiligo. Horizontal excision with histopathology confirmed seborrheic keratosis (SK) without atypia. This case highlights that the halo phenomenon can occur in non-melanocytic lesions, including SK,1 a presentation that may mimic melanoma and complicate diagnosis in richly pigmented skin.2,3 We review halo SK, discuss dermoscopic–pathologic features that distinguish it from melanoma and adult-onset halo nevus, and summarize evidence-based therapies for coexisting vitiligo, including topical ruxolitinib 1.5% cream and narrowband UVB (NB-UVB).4,5  .

Background: Regenerative dermatology is an emerging subspecialty that seeks to restore the structure and function of healthy skin. The United States lacks comprehensive regulatory guidance for regenerative therapies. This review provides an overview of available therapies within regenerative dermatology, outlining the pathways for approval.

Methods: Articles on regenerative dermatology in PubMed and guidelines issued by the United States Food and Drug Administration (FDA) were reviewed with emphasis on those published between June 2020 and June 2025, and results were summarized in narrative format.

Results: In the United States, the FDA is the primary regulatory authority responsible for ensuring the safety and efficacy of regenerative biotherapeutics. Classification of a product as a drug, biologic, device, or cosmetic determines the regulatory pathway it must follow.

Discussion: Cosmetics are intended to promote attractiveness without treating or preventing disease and do not require FDA approval prior to marketing, while drugs and biologics undergo a multi-step process to obtain approval: (1) product development, (2) preclinical testing in a laboratory setting, (3) clinical trials involving human subjects, (4) FDA review, and (5) FDA approval. High-risk devices require a Premarket Approval (PMA), while low-to-moderate risk devices have less stringent requirements.

Conclusion: Regenerative dermatology offers significant therapeutic potential. Regulation is governed by the US FDA and varies according to product classification. Clinicians should counsel patients on safety and efficacy data prior to initiating regenerative treatments.  .

Background: Hyperpigmentation disorders are common skin concerns that negatively impact patient quality of life and self-perception. Hyperpigmentation results from the overproduction of melanin via a multi-step process with a rate-limiting step catalyzed by tyrosinase. Thiamidol, an effective human tyrosinase inhibitor, has recently been shown to reduce visible signs of hyperpigmentation and could provide additional benefits when combined with the standard of care treatment for hyperpigmentation: photoprotection, specifically sunscreens with sun protection factor (SPF).

Methods: A randomized study was performed with 95 subjects (n=47, Thiamidol regimen; n=48, standard SPF 30 lotion) aged 18–65 clinically presenting with facial hyperpigmentation (measured by colorimeter and individual typology angle [ITA°]) to assess the efficacy of the Thiamidol-containing regimen (Day Lotion with SPF 30 and Serum applied in the morning, Night Cream and Serum applied in the evening) compared with a standard SPF 30 lotion for 12 weeks, followed by a 6-week regression phase.

Results: Facial hyperpigmentation, measured by skin lightness, ITA° values, radiance, and shine, was significantly reduced relative to baseline for both groups as early as week 2, and significantly reduced for patients receiving the Thiamidol-containing regimen vs the standard SPF 30 lotion at weeks 8 and 12.

Discussion: This study demonstrates that while SPF alone can reduce the visible signs of hyperpigmentation, the addition of Thiamidol to a daily skin care regimen confers additional, durable benefits with regard to skin lightness, radiance, and shine.

Conclusion: These data support the integration of Thiamidol-containing formulations into existing skin regimens for individuals with facial hyperpigmentation.  .

Background: Atopic dermatitis (AD) disproportionately affects diverse patient populations, and complex factors influence access to treatment among different racial and ethnic groups.

Objective: This study aimed to assess racial and ethnic differences in AD severity and access to treatment in clinical practice.

Methods: The study included patients aged 6 and older with AD enrolled in TARGET-DERM AD, an observational, longitudinal study utilizing electronic medical records from 43 academic and community centers across the United States.

Results: The analysis included 1,928 participants: 577 children (30%) and 1,351 adults (70%), with 42% identifying as Non-White. Non-Hispanic (NH) Asian participants exhibited the highest percentage of moderate-to-severe AD at 63%, followed by NH-Black (61%), Hispanic (49%), and NH-White (48%) participants. Over half (56%) of NH-Asian patients reported comorbid asthma. NH-Black and Hispanic individuals were less likely to receive advanced systemic therapies compared to NH-White individuals, with odds ratios of 0.71 and 0.66, respectively, both statistically significant (P<0.01).

Conclusion: Despite having moderate-to-severe AD, NH-Black and Hispanic patients had significantly lower odds of receiving advanced systemic therapy compared to NH-White patients, highlighting potential disparities in access to advanced treatments for AD.  .