BACKGROUND:Although topical retinoids are first-line therapy for mild-to-moderate acne, treatment-related irritation often limits adherence to long-term therapy. However, dermocosmetic adjuncts may improve treatment outcomes and tolerability. AIM:To assess the efficacy and tolerability of a triple acid-containing serum (TAS) in mild-to-moderate acne. METHODS:An 8-week, open-label, randomized controlled trial of 41 patients with mild-to-moderate acne was performed. The participants received either TAS + adapalene gel (AG) (treatment group) or AG alone (control group) for 4 weeks, followed by a 4-week maintenance phase in which AG was discontinued, and TAS was continued only in the experimental group. Lesion counts, Investigator Global Assessment (IGA), microcomedone counts, skin physiological parameters, and VISIA-CR were performed at baseline and 2, 4, and 8 weeks. RESULTS:A significantly greater reduction in noninflammatory, inflammatory, and total lesions, IGA scores, and microcomedone counts was observed in the experimental group. The control group showed rebound worsening after AG withdrawal. Improvements in skin physiological parameters were observed in both groups, although without statistical significance. Mild and transient adverse events occurred. CONCLUSION:TAS in combination with AG was shown to improve mild-to-moderate acne with good tolerability and may effectively reduce the recurrence rate when applied as a maintenance treatment post-AG.

Objectives This post-hoc analysis of CM310AD005 conductedaimed to analyze the efficacy and safety of stapokibart in adults with moderate-to-severe atopic dermatitis (AD) with and without prior systemic treatment.Methods In CM310AD005, eligible patients were randomized 1:1 to receive stapokibart 600 (loading dose)-300 mg and placebo Q2W for 16 weeks; all patients subsequently received stapokibart 300 mg Q2W for 36 weeks.Results At week 16, in systemic treatment-naïve patients, stapokibart led to significantly higher response rates than placebo for ≥75% improvement from baseline in the Eczema Area and Severity Index score (EASI-75, 70.3% vs. 29.1%), EASI-90 (38.1% vs. 13.3%), Investigator’s Global Assessment score of 0 or 1 (45.2% vs. 19.4%), and ≥4-point reduction in weekly average of daily Peak Pruritus Numerical Rating Scale score (34.8% vs. 13.9%) (all p < 0.0001). Among patients with prior systemic treatment, these response rates were also significantly higher in the stapokibart group, reaching 61.5% vs. 19.3%, 35.4% vs. 7.2%, 42.7% vs. 9.6%, and 37.5% vs. 7.2% (all p < 0.0001), respectively. All patients showed further improvements through week 52. The most common treatment-emergent adverse events were infections and infestations, occurring in 61.6% and 70.5% of patients with and without prior systemic treatment.Conclusions Stapokibart demonstrated significant clinical efficacy and manageable safety in AD patients irrespective of prior systemic treatment.

Adalimumab, a monoclonal antibody targeting tumor necrosis factor-alpha, has been approved for the treatment of severe plaque psoriasis in children aged 4 years and older. Data on its use in the clinical management of pediatric psoriasis in China remains limited. This study is the first prospective analysis of the adalimumab biosimilar (GELELI®, the first biosimilar of adalimumab approved in China, and QLETLI® in the UK) safety and effectiveness for severe pediatric plaque psoriasis in China. Weight-based dosage was administered to 80 patients (ages 4–18 years) from multiple centers. Primary endpoints included the proportions of patients achieving PASI75 and PGA 0/1 at week 16. The mean psoriasis area and severity index (PASI) score decreased from 15.31 ± 8.375 at baseline to 6.29 ± 4.208 at week 4. PASI 50/90/100 response rates were 91.1

BACKGROUND:Eosinophils are involved in the pathogenesis of atopic dermatitis (AD). OBJECTIVE:This post-hoc analysis evaluated the effect of stapokibart on blood eosinophil counts in moderate-to-severe AD patients. METHODS:The phase II AD002 trial (n = 120) randomly assigned patients to stapokibart 300 mg every 2 weeks (Q2W), 150 mg Q2W, or placebo for 16 weeks. The phase III AD005 trial (n = 500) randomly assigned patients to stapokibart 300 mg Q2W or placebo for 16 weeks, followed by open-label stapokibart 300 mg Q2W for 36 weeks. Efficacy and safety were analyzed in subgroups stratified by baseline blood eosinophil counts (≥500 or <500 cells/µL). RESULTS:Stapokibart treatment resulted in sustained reductions in blood eosinophil counts versus placebo (baseline vs. Week 16: high-dose 420 vs. 235 cells/μL, low-dose 530 vs. 315 cells/μL in AD002; 370 vs. 210 cells/μL in AD005). Furthermore, stapokibart demonstrated superior efficacy over placebo in achieving higher Eczema Area and Severity Index (EASI)-75 response rates at Week 16 in both eosinophil subgroups. The incidence of adverse events was similar across eosinophil subgroups, with most events being mild or moderate. CONCLUSION:Stapokibart reduced blood eosinophil counts in AD patients and demonstrated favorable efficacy and safety regardless of baseline blood eosinophil counts.

BACKGROUND:Effective topical therapies for mild-to-moderate atopic dermatitis (AD) should provide rapid itch relief, sustained anti-inflammatory efficacy and minimal local toxicity. Existing options, including corticosteroids and calcineurin inhibitors, are limited by long-term adverse effects, highlighting the need for safer, steroid-sparing alternatives. OBJECTIVES:To evaluate the efficacy and safety of ivarmacitinib ointment, a highly selective topical Janus kinase 1 inhibitor, applied twice daily in adults with mild-to-moderate AD. METHODS:This phase III evaluation was part of a multicentre randomized double-blind vehicle-controlled seamless adaptive phase II/III trial conducted at 27 sites in China. Adults aged 18-75 years with Hanifin-Rajka-defined mild-to-moderate AD were randomized (1 : 1 : 1) to ivarmacitinib ointment 0.5%, ivarmacitinib ointment 1% or vehicle for 8 weeks. Patients who initially received the vehicle were re-randomized to active treatment for a blinded extension through week 52. Co-primary endpoints were Investigator's Global Assessment (IGA) response (score 0/1 with ≥ 2-grade improvement) and ≥ 75% improvement in Eczema Area and Severity Index (EASI 75) at week 8. RESULTS:At week 8, significantly more patients achieved an IGA response with ivarmacitinib than with vehicle [ivarmacitinib 0.5%: 21.3% vs. 10.6% (P = 0.02); ivarmacitinib 1%: 26.2% vs. 10.6% (P = 0.001)]. Likewise, EASI 75 responses were higher [ivarmacitinib 0.5%: 42.6% vs. 17.9%; ivarmacitinib 1%: 45.1% vs. 17.9% (both P < 0.001)]. Relief from pruritus was seen within 48 h and maintained through week 52, with sustained improvements in SCORing Atopic Dermatitis (SCORAD), affected body surface area and Dermatology Life Quality Index. During the vehicle-controlled period, treatment-emergent adverse events occurred in 42.6% (n = 52/122), 56.6% (n = 69/122) and 52.0% (n = 64/123) of patients in the ivarmacitinib 0.5%, ivarmacitinib 1% and vehicle groups, respectively; most were mild and infection-related events were infrequent. No treatment-related adverse event occurred in ≥ 2% of patients in the ivarmacitinib 1% or vehicle groups, while in the ivarmacitinib 0.5% group, only folliculitis (n = 5/122; 4.1%) and increased blood uric acid (n = 4/122; 3.3%) were reported in ≥ 2% of patients. No skin atrophy, telangiectasia or application-site irritation was observed. Long-term safety through week 52 remained consistent, with no new safety signals noted. CONCLUSIONS:Twice-daily ivarmacitinib ointment (0.5% or 1%) produced rapid, durable and well-tolerated improvements in the signs, symptoms and itch experienced by adults with mild-to-moderate AD, supporting its potential as a safe, steroid-sparing topical therapy.

SHR-1819 is a novel monoclonal antibody targeting IL-4Rα, developed for the treatment of type 2 inflammatory diseases such as atopic dermatitis (AD). This phase 2 study aimed to evaluate SHR-1819 for treating moderate-to-severe AD. Patients with an Eczema Area and Severity Index (EASI) score ≥ 16, an Investigator’s Global Assessment (IGA) score ≥ 3, and ≥ 10

BACKGROUND:Elderly patients with moderate-to-severe atopic dermatitis (AD) often exhibit more heterogeneous inflammatory profiles compared with younger adults. To evaluate the efficacy and safety of stapokibart, an anti-interleukin-4 receptor α subunit (IL-4Rα) monoclonal antibody, in different age subgroups. METHODS:Eligible adults were randomized to receive subcutaneous stapokibart 300 mg every 2 weeks (Q2W; loading dose 600 mg) or placebo for 16 weeks. All patients subsequently received stapokibart 300 mg Q2W for 36 weeks. In this post hoc analysis, patients were classified as elderly (aged ≥ 60 years, n = 93) and non-elderly patients (aged 18 and < 60 years, n = 407). Main efficacy outcomes included ≥ 75% improvement from baseline in Eczema Area and Severity Index (EASI-75), Investigator's Global Assessment (IGA) 0/1, and ≥ 4-point reduction in weekly average of daily peak pruritus Numerical Rating Scale (PP-NRS) score. RESULTS:In elderly patients at Week 16, response rates for stapokibart versus placebo were 56.0% vs. 14.0% for EASI-75 (p < 0.0001), 40.0% vs. 7.0% for IGA 0/1 (p = 0.0003), and 32.0% vs. 7.0% for ≥ 4-point reduction in weekly average of daily PP-NRS (p = 0.0023). In non-elderly patients, corresponding response rates were 69.7% vs. 28.3%, 45.3% vs. 18.0%, and 36.8% vs. 12.7%, respectively (all p < 0.0001). Within both age subgroups, progressive improvements across all efficacy measures were observed during the maintenance treatment period. The incidence of treatment-emergent adverse events was similar between stapokibart and placebo groups during the 16-week treatment period, regardless of age. CONCLUSION:Stapokibart was effective and had a favorable safety profile in elderly patients with moderate-to-severe AD.

Background Prior exposure to systemic treatments may affect treatment outcomes in moderate-to-severe atopic dermatitis (AD).Objective This study aimed to explore the efficacy and safety of Ivarmacitinib (SHR0302) in moderate-to-severe AD patients with or without previous systemic treatments.Methods This was a post-hoc analysis of a phase III clinical trial of Ivarmacitinib in moderate-to-severe AD (NCT04875169). Subgroup analysis by with (N = 132) or without (N = 204) previous systemic treatments (systemic corticosteroids, biologics, or other immunomodulators) was performed.Results In patients with previous systemic treatments, Ivarmacitinib 8 mg (n = 34) and 4 mg (n = 53) exhibited higher Investigator Global Assessment (IGA), Eczema Area and Severity Index (EASI)-75, EASI-90, and Worst Itch Numeric Rating Scale (WI-NRS) 4 response rates, and a greater reduction in Dermatology Life Quality Index (DLQI) score compared with placebo (n = 45) at most timepoints from W4 to W16. In patients without previous systemic treatments, these outcomes were notably increased in Ivarmacitinib 8 mg (n = 78) and 4 mg (n = 60) versus placebo (n = 66) throughout W4 to W16. The adverse events were generally comparable between Ivarmacitinib and placebo groups, regardless of previous systemic treatments.Conclusion Ivarmacitinib demonstrates good efficacy and a favorable safety profile in moderate-to-severe AD patients, irrespective of previous systemic treatments.

Background: Stapokibart has been approved for the treatment of adults with atopic dermatitis (AD) in China.Objective: To report long-term efficacy of stapokibart in patients with moderate-to-severe AD.Methods: This post hoc analysis included 237 adult patients from a phase 3 trial (NCT05265923) who received stapokibart 300 mg (loading dose, 600 mg) every 2 weeks during the 16-week double-blind period and continued with the same dose of stapokibart in the subsequent 36-week maintenance period.Results: At week 20, 100% and 92.2% of patients who achieved coprimary endpoints (≥75% improvement in Eczema Area and Severity Index [EASI-75] and Investigator's Global Assessment [IGA] 0/1 response) at week 16 retained their EASI-75 and IGA 0/1 response, respectively. At week 52, these figures reached 99.0% and 87.0%, respectively. Among those who had not achieved EASI-75 or IGA 0/1 at week 16, 65.4% achieved EASI-75 and 18.1% achieved IGA 0/1 at week 20, and reached 86.8% and 50.0% at week 52, respectively. The patient-reported outcomes also improved sustainedly.Conclusions: Long-term stapokibart treatment induced sustained clinical improvements in adult patients with moderate-to-severe AD, regardless of their initial response to 16-week treatments.

Atopic dermatitis (AD) significantly impairs quality of life and requires long-term management. This post hoc analysis aimed to evaluate the effect of stapokibart (an anti-IL-4Rα antibody) on patient-reported outcomes (PROs) in adults with moderate-to-severe AD from a phase 3 trial (NCT05265923). Eligible patients were randomized 1:1 to receive stapokibart 300 mg (loading dose 600 mg) (n = 251) or placebo (n = 249) every 2 weeks (Q2W) for 16 weeks. Subsequently, both groups received stapokibart 300 mg Q2W for 36 weeks and were followed-up for 8 weeks. Main PROs analyzed included percentage change from baseline in the Dermatology Life Quality Index (DLQI) and the Patient-Oriented Eczema Measure (POEM) scores, response rates of weekly average of daily Peak Pruritus Numerical Rating Scale (PP-NRS) score ≤ 4 and ≤ 1, DLQI score ≤ 5, and POEM score ≤ 7 over 52-week treatment. A higher proportion of patients in the stapokibart group achieved weekly average of daily PP-NRS score ≤ 4 compared with the placebo-stapokibart group at week 16 (49.8

Background::Topical finasteride is a novel treatment for men with androgenetic alopecia (AGA). This study aimed to evaluate the efficacy and safety of topical finasteride spray solution in Chinese men with AGA.Methods::This randomized, double-blind, placebo-controlled, phase III trial enrolled 270 individuals with AGA from 16 sites across China between December 2021 and March 2023. The participants were randomized at a ratio of 2:1 to receive either topical finasteride or placebo treatment once daily for 24 weeks. The primary endpoint was the change from baseline in target area (0.903 cm 2 area) hair count at week 24. The secondary endpoints were change from baseline in target area hair count at week 12, target area terminal hair count at weeks 12 and 24, target area terminal hair width at week 24, and target area hair width at week 24; an improvement of vertex hair growth assessed by the investigator at week 24; and the patient-assessed scores on the Male Hair Growth Questionnaire at week 24. Results::A total of 270 individuals were enrolled and randomized, and 251 completed the study (165 in topical finasteride group, 86 in placebo group). Compared with the placebo group, in the topical finasteride group, the change from baseline in target area hair count was significantly higher at week 24 ( P <0.05), although it was only numerically higher at week 12 ( P = 0.0688). Significant differences favoring topical finasteride over placebo were observed for change from baseline in target area terminal hair count at weeks 12 ( P <0.05) and 24 ( P <0.01). The improvement of vertex hair growth assessed by the investigator was significantly greater in the topical finasteride group vs. the placebo group at week 24 ( P <0.01). Topical finasteride was generally safe and well-tolerated. Conclusions::In Chinese men with AGA, topical finasteride spray solution increased hair growth and showed good safety and tolerability profile during a 24-week treatment period.

BACKGROUND:Atopic dermatitis (AD) often coexists with other type 2 inflammatory diseases. Stapokibart, a humanized IgG4 monoclonal antibody targeting interleukin-4 receptor alpha subunit, showed high efficacy and favorable safety in a phase 3 trial. This post-hoc analysis aimed to compare the efficacy and safety of stapokibart in AD patients with and without type 2 comorbidities. METHODS:During 16-week double-blind period, participants were randomly assigned to stapokibart 600 (loading dose)-300 mg (n = 251) or placebo (n = 249) treatment every other week (Q2W). All patients received stapokibart 300 mg Q2W during subsequent 36-week maintenance period. Patients with ≥ 1 of the following conditions were classified into comorbid subgroup: allergic rhinitis, asthma, food allergies, chronic urticaria, or chronic obstructive pulmonary disease. Post-hoc outcomes included response rates of ≥ 75%/90% improvement in Eczema Area and Severity Index score (EASI-75/90), Investigator's Global Assessment score of 0 or 1 (IGA 0/1) with ≥ 2-point reduction, and ≥ 4-point reduction in weekly average of daily peak pruritus numerical rating scale score (PP-NRS4), and the percentage change from baseline in weekly average of daily PP-NRS score. Treatment-emergent adverse events (TEAEs) were also analyzed by subgroups. RESULTS:Ninety-two patients (36.7%) in stapokibart group and 102 (41.0%) in placebo group had type 2 comorbidities. The demographic characteristics and baseline disease scores were generally comparable across four groups. At week 16, stapokibart demonstrated superior efficacy over placebo in patients with and without type 2 comorbidities. In patients with comorbidities, the response rates of EASI-75, IGA 0/1, and PP-NRS4 in stapokibart and placebo groups were 77.2% versus 26.5%, 55.4% versus 17.6%, and 43.5% versus 12.7%, respectively. In patients without comorbidities, these response rates were 61.0% versus 25.3%, 37.7% versus 15.1%, and 31.4% versus 11.0%, respectively (all p values < 0.0001). All patients showed further improvements in efficacy outcomes during weeks 20-52. TEAEs occurred in 88.8% and 87.7% of comorbid and non-comorbid patients over weeks 0-52. The incidence of conjunctivitis was 5.9% and 5.0%, respectively. CONCLUSION:Stapokibart was effective and safe in adults with moderate-to-severe AD both with and without type 2 comorbidities in both short-term and long-term treatment. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT05265923.

Background: Despite their ubiquitous use and several safety incidents involving cosmetics for children in China, there is little research on adverse reactions to cosmetics in children. Objectives: We assessed the cosmetic adverse reactions (CARs) reports submitted to the Chongqing Drug Administration in China for children, to understand the characteristics of CARs in a pediatric population and determine whether useful insights can be derived. Methods: We extracted the data file of the Chongqing Drug Administration's cosmetic adverse events reporting system from 2017 to 2021, and screened the information of people under the age of 18 years for analysis. Results: A total of 589 children were reported; of them, 475 female children and 114 male children, aged 1-17 years, and 89.6% were diagnosed with cosmetic contact Dermatitis. Itching and burning were the most prominent symptoms and accounted for 83.4% and 40.2%, respectively. The most frequently reported clinical sign was erythema (73.3%) followed by papule (37.9%). The face is the most vulnerable location to lesions, accounting for 80.8% of all areas, with girls having a significantly higher rate of facial and scalp damage than boys. The majority of the CARs were reported with cream, lotion, and toner for the skin (45.9%) and facial or body cleansing products (15.4%), and most of these products were purchased from authoritative shops. Conclusion: Although adults are the main group of people who use cosmetics, due to the special physiological structure of children, the safety of children's cosmetics should be given more attention. In addition, pediatricians and dermatologists should be active in submitting reports of adverse cosmetic events and encouraging consumers to do so likewise in situations in which a product adversely affects a child's health.

Objective To evaluate the safety and efficacy of skin care product containing arte-misia naphtha in individuals with sensitive skin.Methods A single-center and self-controlled(before and after application)clinical trial was conducted in 31 subjects with sensitive skin.Test product was applied to the face of the subjects twice daily for 4 weeks.Measurement of physiologi-cal function,VISIA-CR photography and lactic acid test were carried out on the skin before and on the days 7,14,28 of the trial.16S rRNA gene sequencing technology was used to analyze the mi-croecological diversity of the skin surface meanwhile physician and subject'self-assessments were performed.Results Physician assessment scores for erythema were decreased at all three follow-up visits(P＜0.05 vs.baseline).The subjects'self-assessments of itching,tingling,burning,tightness,flushing and sensitivity scores were also decreased(all P＜0.05 vs.baseline).The skin a*values were decreased significantly(all P＜0.05 vs.baseline).Similarly,erythema in-dex was significantly decreased(all P＜0.05 vs.baseline).Moreover,stratum corneum hydra-tion levels were significantly increased on D7 and D28(all P＜0.05 vs.baseline).The transepi-dermal water loss rates tended to decrease,and were significantly different between the baseline and day 14(P＜0.05).In contrast,the skin elasticity and firmness parameters were not changed significantly.Furthermore,lactic acid scores were decreased significantly on D14 and D28(all P＜0.001 vs.baseline).Additionally,there was a tendency of increases in alpha diversity indices ACE and Chaol on days D7 and D14,with a significant increase on day 14(P＜0.05 vs.base-line).Beta diversity analysis showed that the four groups of samples failed to gather into clusters,and the differences in composition structure were not significant.No adverse reactions were ob-served during the trial.Conclusions Skin care product containing artemisia naphtha is safe for individuals with sensitive skin and improves multiple clinical signs and symptoms of sensitive skin,including acceleration of the skin barrier recovery,elevation in stratum corneum hydration,reduc-tion in transepidermal water loss rates and lactate stinging test score,alleviation of itching,ting-ling,burning,tightness and flushing,and increases in the richness and diversity of facial skin microbiota.