BACKGROUND: Reconstruction of full-thickness lower-lip defects after skin cancer excision is challenging, as both oral function and appearance must be restored. Conventional methods may be insufficient for moderate-sized...BACKGROUND: Reconstruction of full-thickness lower-lip defects after skin cancer excision is challenging, as both oral function and appearance must be restored. Conventional methods may be insufficient for moderate-sized defects. MATERIALS AND METHODS: This prospective observational study included 36 patients with T1-T2N0M0 basal or squamous cell carcinoma (SCC) of the lower lip treated between January 2021 and April 2023. Defects involving roughly one-third to two-thirds of the lip were repaired using a combined subcutaneous pedicle flap and labial mucosa flap. Patients were followed for 6-24 months. Functional and aesthetic outcomes, wound healing, scar quality, and recurrence were assessed using standardized scoring systems. RESULTS: Delayed healing was more common in patients over 70 years (37.5% . 5.0%). Defects > 2.0 cm had lower functional scores and higher delayed healing. Moist wound care reduced delayed healing compared with dry healing (exploratory). Tumor recurrence was 10.5% for SCC and 5.8% for BCC. Overall, functional and aesthetic outcomes remained high. CONCLUSIONS: The combined flap technique is a safe, effective option for moderate-sized full-thickness lower-lip defects, providing reliable functional restoration and satisfactory cosmetic results.
OBJECTIVES: Off-label prescribing is a common and often necessary practice in dermatology, as approved treatment options frequently fail to meet the diverse needs of patients. This is particularly relevant in the managem...OBJECTIVES: Off-label prescribing is a common and often necessary practice in dermatology, as approved treatment options frequently fail to meet the diverse needs of patients. This is particularly relevant in the management of two prevalent inflammatory dermatoses - atopic dermatitis and psoriasis. Despite the widespread use of off-label therapies, their application often lacks formal guidance, highlighting the need for updated clinical recommendations and consideration of expanded drug indications. METHODS: This retrospective study analyzed medical records of 5072 patients with atopic dermatitis and/or psoriasis who were treated in Northern Poland between 2014 and 2024. RESULTS: It was found that 62.5% of patients with atopic dermatitis and 25.7% of patients with psoriasis received some form of off-label treatment. The frequency of off-label therapy demonstrated an inverse correlation with patient age. On average, individuals managed with a combination of on-label and off-label therapies achieved greater reductions in EASI, PASI, and DLQI scores compared to those treated exclusively according to SmPC guidelines, with the statistically significant difference for PASI reductions. CONCLUSIONS: Off-label treatment is widely used in the management of both atopic dermatitis and psoriasis. Real-world evidence plays a crucial role in guiding clinical practice and should be leveraged to support the more evidence-based implementation of off-label therapies.
OBJECTIVES: Facial and genital plaques are common manifestations of psoriasis, are challenging to treat, and significantly impact patients' quality of life (QoL). METHODS: GULLIVER is a prospective, non-interventional st...OBJECTIVES: Facial and genital plaques are common manifestations of psoriasis, are challenging to treat, and significantly impact patients' quality of life (QoL). METHODS: GULLIVER is a prospective, non-interventional study conducted in 2020-2023 in Italy, aimed at examining the effectiveness, safety and QoL impact of guselkumab through 52 weeks of treatment in patients with facial and/or genital psoriasis. The primary endpoint was the percentage of patients achieving a static Physician Global Assessment (sPGA) score of ≤1 and a minimum 2-grade improvement in sPGA score at Week 52. RESULTS: Of 351 enrolled patients, 88.6% remained on guselkumab treatment at Week 52. The proportions of patients achieving the sPGA targets in the facial and genital groups, respectively, were 83.3% and 76.5% at week 12, increasing to 93.8% and 97.9% at Week 52. Mean Dermatology Life Quality Index score improved from 12.0 ± 7.5 at baseline to 1.1 ± 2.0 at Week 52 for patients with facial psoriasis (-value <0.001) and from 12.0 ± 6.9 to 1.6 ± 3.5 for those with genital psoriasis (-value <0.001). Guselkumab was well-tolerated and no new safety signals were identified. CONCLUSIONS: This Italian real-world study demonstrated the high effectiveness and a good safety profile of guselkumab in treating facial and genital psoriasis.
BACKGROUNDS: Prurigo nodularis (PN) is a chronic pruritic inflammatory disease associated with immune and neural dysregulation. Although nemolizumab has demonstrated efficacy in clinical trials, real-world post-marketing...BACKGROUNDS: Prurigo nodularis (PN) is a chronic pruritic inflammatory disease associated with immune and neural dysregulation. Although nemolizumab has demonstrated efficacy in clinical trials, real-world post-marketing data remain limited. OBJECTIVE: To evaluate the real-world efficacy, safety, and drug survival of nemolizumab in patients with PN. MATERIALS AND METHODS: We retrospectively analyzed 38 patients with PN treated with nemolizumab at a single center. Peak Pruritus Numerical Rating Scale (PP-NRS) and Prurigo Nodularis Investigator's Global Assessment (PN-IGA) were assessed up to Week 24. Treatment-emergent adverse events (TEAEs) and drug survival were evaluated. RESULTS: Mean PP-NRS rapidly improved from 8.1 at baseline to 1.8 at Week 8 and remained stable through Week 24 ( < 0.001). PN-IGA scores gradually improved from 3.1 to 1.4 by Week 24 ( < 0.01). At Week 24, ≥4-point PP-NRS improvement and PP-NRS 0/1 were achieved in 90.9% and 59.1% of patients, respectively, while PN-IGA 0/1 was achieved in 50.0%. Early PP-NRS improvement correlated with long-term outcomes. TEAEs occurred in 39.5%, mainly cutaneous reactions, and drug survival was significantly lower in patients with TEAEs. CONCLUSION: Nemolizumab provided rapid and sustained itch relief with gradual lesion improvement in real-world PN. Early pruritus response may predict long-term efficacy, while adverse events affect treatment persistence.
OBJECTIVE: To compare the effectiveness and safety of pharmacological, physical, and complementary interventions for recurrent aphthous stomatitis (RAS) across clinically relevant outcomes. METHODS: This umbrella review...OBJECTIVE: To compare the effectiveness and safety of pharmacological, physical, and complementary interventions for recurrent aphthous stomatitis (RAS) across clinically relevant outcomes. METHODS: This umbrella review was conducted according to PRISMA and Cochrane guidance and registered in PROSPERO (CRD42024594292). PubMed, Scopus, and the Cochrane Library were searched through August 2025. Eligible studies were systematic reviews, meta-analyses, or network meta-analyses evaluating treatments for RAS. Methodological quality was assessed using AMSTAR 2, and overlap of primary studies was quantified using the corrected covered area. RESULTS: A total of 41 reviews were included. Topical corticosteroids and low-level laser therapy consistently reduced pain and shortened healing time, although evidence for recurrence prevention was limited. Hyaluronic acid and herbal agents demonstrated favorable short-term efficacy with good safety profiles. Systemic agents such as colchicine and thalidomide showed benefit in severe or refractory RAS, but were constrained by the adverse effects and low-certainty evidence. CONCLUSION: Evidence supports topical corticosteroids, hyaluronic acid, and laser therapy for short-term symptom control in RAS, while systemic agents should be reserved for selected refractory cases.
BACKGROUND: Facial aging is characterized by midface volume loss from structural and dermal atrophy. OBJECTIVES: To evaluate the efficacy and safety of a hyaluronic acid-polynucleotide (HA-PN) hybrid filler for temporary...BACKGROUND: Facial aging is characterized by midface volume loss from structural and dermal atrophy. OBJECTIVES: To evaluate the efficacy and safety of a hyaluronic acid-polynucleotide (HA-PN) hybrid filler for temporary restoration of anteromedial cheek volume. METHODS: In this single-center, open-label trial, 15 adults with moderate-to-severe anteromedial cheek volume loss (Mid-Face Volume Deficit Scale [MFVDS] score ≥ 3) received up to 1 mL HA-PN hybrid filler per side. Evaluations at baseline and weeks 4, 12, and 24 comprised blinded photographic MFVDS rating (primary endpoint: ≥1-grade improvement at week 4), GAIS (Global Aesthetic Improvement Scale) score, participant satisfaction, transepidermal water loss, skin hydration, elasticity, and adverse events. RESULTS: All participants completed the study without serious adverse events. MFVDS scores improved significantly at week 4 and remained improved through weeks 12 and 24. GAIS and satisfaction scores paralleled these gains. Transepidermal water loss decreased and hydration increased over time, and Cutometer parameters (R2 R5 R7) showed progressive improvements in elasticity, indicating enhanced skin quality along with midface volumization. CONCLUSIONS: The HA-PN hybrid filler demonstrated improvements in midface volume restoration with concurrent improvements in skin barrier function, hydration, and elasticity, and was well tolerated over 24 weeks within the constraints of the study design.
Li Y, Yu B, Niu S
… +17 more, Ding Z, Gu Q, Zhang H, Ding R, Zhou C, Men F, Liu Y, Zhao W, Chen L, Li S, Wang Q, Xiao M, Huang F, Hu B, Zhang J, Zhang J, Fang Y
OBJECTIVES: Compared with placebo, this phase I study evaluated the safety, tolerability, and pharmacokinetics of CG2001, a novel isopropyl alcohol-free minoxidil-finasteride combination topical foam, in Chinese males wi...OBJECTIVES: Compared with placebo, this phase I study evaluated the safety, tolerability, and pharmacokinetics of CG2001, a novel isopropyl alcohol-free minoxidil-finasteride combination topical foam, in Chinese males with androgenetic alopecia (AGA). METHODS: In this randomized, double-blind, placebo-controlled trial, 44 subjects received single and multiple doses across five cohorts with varying finasteride concentrations (0.025%-0.1%) and frequencies. Safety, tolerability, and pharmacokinetics were evaluated. The concentrations of minoxidil-finasteride were both measured. RESULTS: The result shows that CG2001 was safe and well-tolerated, with no serious adverse events. Systemic minoxidil exposure was consistent across most dosages, while finasteride exposure increased dose- and frequency-dependently, though it remained markedly lower than that reported with oral administration. Steady state was achieved for both drugs after 7 days. CONCULSIONS: The favorable safety profile and reduced systemic finasteride exposure position CG2001 as a promising alternative, supporting further clinical development in a phase IIa trial, and provide a pharmacokinetic foundation for subsequent efficacy trials in patients with AGA.
BACKGROUND: Ivarmacitinib (SHR0302) is a novel and highly selective Janus kinase 1 inhibitor for treating moderate to severe atopic dermatitis (AD). OBJECTIVE: This study aimed to evaluate the impacts of patient characte...BACKGROUND: Ivarmacitinib (SHR0302) is a novel and highly selective Janus kinase 1 inhibitor for treating moderate to severe atopic dermatitis (AD). OBJECTIVE: This study aimed to evaluate the impacts of patient characteristics on the efficacy and safety of Ivarmacitinib. METHODS: This post-hoc analysis used data from a randomized, double-blind, placebo-controlled, multicenter phase 3 trial of Ivarmacitinib in patients with moderate to severe AD in which patients were randomized (1:1:1) to receive Ivarmacitinib 4 mg or 8 mg or placebo for 16 weeks. Subgroup analyses were conducted based on baseline characteristics. RESULTS: At week 16, both Ivarmacitinib 4 or 8 mg showed better efficacy over placebo in achieving Eczema Area and Severity Index (EASI) 75, EASI 90, and Worst Itch Numeric Rating Scale (WI-NRS) score ≥4-point responses in most subgroups based on age, sex, body mass index, AD duration, Investigator's Global Assessment score, EASI score, WI-NRS score, body surface area involvement, history of comorbid allergies, or previous systemic therapies. The overall incidence of adverse events and most of the adverse events of special interest were similar between Ivarmacitinib and placebo across all subgroups. CONCLUSION: Ivarmacitinib demonstrated efficacy and good tolerability in treating moderate to severe AD with diverse patient characteristics.
BACKGROUND/OBJECTIVES: The concept of super responders (SRs) has gained increasing attention in psoriasis. However, evidence focusing exclusively on risankizumab remains limited. This multicenter, international, real-wor...BACKGROUND/OBJECTIVES: The concept of super responders (SRs) has gained increasing attention in psoriasis. However, evidence focusing exclusively on risankizumab remains limited. This multicenter, international, real-world study aimed to assess the prevalence, predictors, and long-term maintenance of SR status among patients with moderate-to-severe plaque psoriasis treated with risankizumab. METHODS: A retrospective observational study was conducted across 10 Italian and Portuguese referral centers. SRs were defined as patients achieving complete skin clearance (PASI 0) at week 20. Predictors of SR achievement and maintenance were assessed using multivariate logistic regression models at weeks 52, 104, and 130 (2.5 years). RESULTS: A total of 1372 patients were included (mean PASI 14.9 ± 8.2). At week 20, 610 (44.5%) achieved PASI 0 and were classified as SRs; 84.4% maintained this status at week 52 and 64.9% at 2.5 years. Biologic-naïve status (OR 1.65; < 0.001) predicted SR achievement, whereas palmoplantar psoriasis (OR 0.58; = 0.005) and higher BMI (OR 0.96; = 0.011) negatively influenced it. Biologic-naïve status remained the strongest predictor of long-term maintenance (OR 2.87; = 0.003). CONCLUSIONS: Risankizumab demonstrated high and sustained long-term effectiveness, inducing rapid and sustained complete clearance in a substantial proportion of patients.
AIM: Given the chronic nature of acne, two 6-month studies were conducted to evaluate the long-term efficacy and tolerability of clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% gel (CAB)-the only a...AIM: Given the chronic nature of acne, two 6-month studies were conducted to evaluate the long-term efficacy and tolerability of clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% gel (CAB)-the only approved triple-combination acne topical-and its effects on scarring/dyspigmentation in participants with moderate to severe acne. MATERIALS AND METHODS: Data were pooled from 2 identical, open-label, single-center studies conducted in participants ( = 50) aged ≥12 years with Investigator's Global Assessment (IGA) score of 3/4. Endpoints included change from baseline in IGA score, inflammatory/noninflammatory lesions, skin appearance (dryness, postinflammatory hyperpigmentation [PIH], postinflammatory erythema [PIE]), and scarring. Adverse events and tolerability (itching, burning, redness, swelling) were assessed. RESULTS: At week 24, 67% of participants achieved treatment success, and significant reductions from baseline in inflammatory (88%) and noninflammatory (68%) lesions were observed ( < 0.001, both). Significant reductions in scarring (33%), investigator- and participant-assessed PIH (71%; 78%, respectively), and PIE (77%; 77%, respectively) were demonstrated ( < 0.001, all). Most participants (>70%) reported no tolerability issues throughout the studies. Seven adverse events occurred; 4 were related to CAB, and 3 led to study discontinuation (BPO allergy [ = 2], irritant contact dermatitis to BPO [ = 1]). CONCLUSIONS: These findings suggest that CAB is an appropriate and effective topical option for the long-term treatment of acne vulgaris.
OBJECTIVES: Vitiligo is an autoimmune skin disorder characterized by melanocyte destruction and frequently associated with autoantibodies such as antinuclear antibodies (ANA). However, the clinical relevance of ANA posit...OBJECTIVES: Vitiligo is an autoimmune skin disorder characterized by melanocyte destruction and frequently associated with autoantibodies such as antinuclear antibodies (ANA). However, the clinical relevance of ANA positivity in relation to phototherapy response remains unclear. This study aimed to evaluate whether ANA positivity influences the efficacy and safety of 308-nm excimer light therapy in patients with vitiligo. METHODS: In this cohort study, 86 patients with vitiligo received 308-nm excimer light therapy combined with topical agents, with oral mini-pulse prednisone added for active disease when necessary. Patients were stratified by ANA status, and therapeutic response was evaluated using the Vitiligo Area Scoring Index and standardized photographs over 6 months. RESULTS: Of the 23 ANA-positive patients (26.7%), 19 (82.6%) had a titer of 1:100 and 4 (17.4%) had a titer of 1:320, with women comprising 73.9% of this group. ANA-positive lesions on the face and neck more frequently achieved moderate repigmentation (50-74%) but were less likely to reach excellent repigmentation (≥75%) compared with ANA-negative lesions. No significant differences were observed in cumulative treatment doses, adverse events, or the occurrence of new autoimmune conditions. CONCLUSIONS: In conclusion, this single-center cohort study suggests that ANA positivity does not significantly affect the efficacy or safety of 308-nm excimer light therapy in vitiligo, indicating that the impact of low-titer ANA may be limited.
BACKGROUND: Oral finasteride 1 milligram (1 mg) daily-which is a 5-alpha reductase inhibitor (5-ARI) approved by the Food and Drug Administration (FDA) for androgenetic alopecia-is linked to sexual adverse events (AEs)....BACKGROUND: Oral finasteride 1 milligram (1 mg) daily-which is a 5-alpha reductase inhibitor (5-ARI) approved by the Food and Drug Administration (FDA) for androgenetic alopecia-is linked to sexual adverse events (AEs). However, it remains unclear whether this link is causal or merely correlational. METHODS: In FAERS, AEs are described by preferred terms (pts) of the Medical Dictionary for Regulatory Activities system; we investigated 8 AEs, including erectile dysfunction (pt = 10,061,461). We determined if signals could be detected with finasteride 1 mg-and 0.5 mg of dutasteride (a more potent 5-ARI)-in FAERS, for sexual AEs related to the post-finasteride syndrome (PFS): for the two, we identified the yearly number of cases (i.e. reports with sexual AEs) from 2006 to 2024. For each AE, we conducted a disproportionality analysis where reporting odds ratios (RORs) were estimated-along with p-values and 95% confidence intervals (CIs). RESULTS: There were more reports with finasteride 1 mg than with dutasteride 0.5 mg; for both, more reporting was observed as of 2012, the year the PFS foundation formally propagated PFS awareness. CONCLUSIONS: Our findings support that the disproportionately higher reporting of sexual AEs with finasteride 1 mg than with dutasteride 0.5 mg-even more so after 2012-could be attributed to the nocebo effect.
OBJECTIVES: IL-17 inhibitors (IL-17i) and IL-23 inhibitors (IL-23i) are advanced treatments for moderate-to-severe plaque psoriasis. This study aimed to assess the persistence of IL-17i and IL-23i in patients with plaque...OBJECTIVES: IL-17 inhibitors (IL-17i) and IL-23 inhibitors (IL-23i) are advanced treatments for moderate-to-severe plaque psoriasis. This study aimed to assess the persistence of IL-17i and IL-23i in patients with plaque psoriasis in Taiwan, where a unique healthcare reimbursement policy makes biologic persistence highly reflective of real-world effectiveness. METHODS: We conducted a retrospective cohort study in bio-naïve patients with plaque psoriasis in Taiwan using the Chang Gung Research Database. Persistence was defined as the duration from initiation to discontinuatin of a biologic agent. Patients who were diagnosed with plaque psoriasis and initiated an IL-17i or an IL-23i between January 2015 and December 2022 were included. Persistence rates were estimated by Kaplan-Meier methods, using discontinuation as the event of interest. RESULTS: A total of 544 and 334 patients were included in the IL-17i and IL-23i cohorts, respectively. Numerically higher persistence was observed for IL-23i compared with IL-17i ( < 0.001). The 48-week and 96-week persistence rates were 71.3% (67.5-75.4%) and 55.2% (50.7-60.1%) for IL-17i, and 82.2% (78.1-86.6%) and 75.1% (70.1-80.5%) for IL-23i. CONCLUSIONS: These findings may inform clinical decision-making by healthcare providers, patients, and policymakers. Further research integrating richer clinical information with extended follow-up will allow deeper investigation of biologic treatment patterns in real‑world settings.
BACKGROUND: Nemolizumab, an anti-IL-31 receptor A antibody, is licensed for atopic dermatitis and prurigo nodularis; its role in other chronic pruritus (CP) syndromes is uncertain. OBJECTIVE: To synthesize efficacy, safe...BACKGROUND: Nemolizumab, an anti-IL-31 receptor A antibody, is licensed for atopic dermatitis and prurigo nodularis; its role in other chronic pruritus (CP) syndromes is uncertain. OBJECTIVE: To synthesize efficacy, safety and strength of evidence for nemolizumab in CP beyond these indications. Methods: We conducted a PROSPERO-registered systematic review (CRD420251207054) of databases and trial registries to November 2025 for nemolizumab studies in CP outside AD/PN. Eligible reports were extracted and patients grouped as systemic, neurologic/neurogenic, dermatologic (non-AD) or primary CP/CP of unknown origin. RESULTS: Seventeen reports (one randomized trial, two cohorts, 14 case series/reports) describing 114 patients were included. In chronic kidney disease-associated pruritus, a phase II hemodialysis trial showed modest, statistically uncertain benefit versus placebo, contrasting with rapid, near-complete relief in dialysis and cholestatic case reports. Uncontrolled data in neuropathic itch/pain syndromes, non-AD inflammatory and papular dermatoses (notably amyloidosis and perforating disorders) and long-standing primary CP/CPUO described complete itch clearance. Across indications, nemolizumab was well tolerated, but certainty was low for CKD-aP and very low for other groups. CONCLUSIONS: Nemolizumab shows plausible antipruritic activity across CP phenotypes, yet the evidence base remains fragile; these signals justify cautious experimental use and prioritize etiology-specific IL-31 receptor blockade trials beyond AD/PN.
BACKGROUND: Dose-stratified real-world data for JAK1 inhibitors in AD are limited. OBJECTIVE: To compare effectiveness and safety of standard vs high doses of abrocitinib and upadacitinib in routine care. METHODS: Multic...BACKGROUND: Dose-stratified real-world data for JAK1 inhibitors in AD are limited. OBJECTIVE: To compare effectiveness and safety of standard vs high doses of abrocitinib and upadacitinib in routine care. METHODS: Multicenter, retrospective cohort study. The primary endpoint was Week-12 achievement of Eczema Area and Severity Index (EASI)-75. Secondary outcomes included patient-reported improvements at Minimal Clinically Important Difference (MCID) thresholds, Minimal Disease Activity (MDA) at Week 36, time-to-EASI-75, and treatment-emergent adverse events(TEAE). RESULTS: A total of 124 patients were analyzed (abrocitinib 100 mg, = 28; abrocitinib 200 mg, = 32; upadacitinib 15 mg, = 30; upadacitinib 30 mg, = 34). At Week 12, EASI-75 was achieved in 20/32 (62.5%) versus 10/28 (35.7%) for abrocitinib (OR 2.94, 95% CI 1.06-8.15; = 0.036) and in 22/34 (64.7%) versus 14/30 (46.7%) for upadacitinib (OR 2.92, 95% CI 1.16-7.38; = 0.021), favoring the higher-dose regimens. Itch improvement was more frequent with higher doses. By Week 36, full minimal disease activity was observed in 30.2% of patients receiving abrocitinib 200 mg and 26.7% receiving upadacitinib 30 mg, compared with 18.4% and 20.0% in the lower-dose groups. Kaplan-Meier analysis showed faster responses with high doses (median 12 vs 36 weeks; log-rank < 0.01). Safety was comparable across groups. CONCLUSION: High-dose JAK1 regimens achieve faster, numerically greater disease control without short-term safety tradeoffs, supporting escalation in suboptimal responders.