BACKGROUND/OBJECTIVES:To estimate the lifetime and point prevalence of alopecia areata (AA) among Australians aged ≥ 15 years. METHODS:A cross-sectional survey was conducted from August to September 2024 in a quota-balanced sample of the Australian population, aged ≥ 12 years (exploratory objective included participants aged 12-14 years). Participants completed the Alopecia Assessment Tool (ALTO) to identify AA. Participants with AA completed the Scalp Hair Assessment Patient-Reported Outcome to assess hair loss and a questionnaire on hair loss experience. Lifetime prevalence was calculated as the proportion of participants with AA per the ALTO, and point prevalence was calculated as the proportion of participants with AA per the ALTO and current scalp hair loss. RESULTS:Of 8,256 participants, 194 had potential AA, and of those, 188 were aged ≥ 15 years. The lifetime prevalence (95% CI) of AA among those aged ≥ 15 years ranged from 1.2% (1.08-1.32) to 2.3% (2.13-2.47), with a point prevalence (95% CI) of 0.9% (0.79-1.01) to 1.4% (1.27-1.53). Of 194 participants with potential AA, 125 had healthcare provider (HCP)-diagnosed AA and 69 had self-diagnosed AA. More self-diagnosed participants had active hair loss than HCP-diagnosed participants. Thirty-nine HCP-diagnosed participants (31.2%) were not using any treatment/management approach, and of those, 23.1% were unaware of treatment/management options. Most self-diagnosed participants were using shampoos/conditioners recommended for hair loss (62.3%). CONCLUSIONS:There is a need for improved AA education in Australia to increase awareness, given that approximately 36% of participants were self-diagnosed and 31% of HCP-diagnosed participants were not using treatment or a management approach.

Importance Alopecia areata (AA) is a chronic, systemic immune-mediated disease characterized by nonscarring hair loss. Many patients do not experience improvements with available treatment options and only ritlecitinib is approved for adolescent patients; therefore, there remains a clear unmet need for additional and improved systemic therapies. Objective To evaluate the efficacy and safety of upadacitinib—an oral selective Janus kinase inhibitor—in adult and adolescent patients with severe AA. Design, Setting, and Participants This global clinical program included 2 parallel phase 3 replicate randomized clinical trials (UP-AA1 and UP-AA2) conducted from October 2023 to July 2025, to evaluate upadacitinib in adolescent and adult patients (age 12 to <64 years old) with severe AA, defined as a Severity of Alopecia Tool (SALT) score of 50 or greater. Both trials included a 24-week placebo-controlled, double-blinded treatment period (period A) and a 28-week blinded extension treatment period (period B). Data were analyzed from July 2025 to October 2025. Interventions Eligible patients were randomized 2:2:1 to once daily 15- or 30-mg upadacitinib or matching placebo. Main Outcomes and Measures Achievement of (multiplicity controlled) SALT score of 20 or less at week 24. Multiplicity-controlled secondary efficacy end points included achievement of improvements in clinician-reported outcomes for eyebrows and eyelashes; achievement of SALT scores of 20 or less at weeks 4, 8, and 12; achievement of SALT score of 10 or less; SALT score 0 at week 24; patients’ global impression of change of AA score of much better or moderately better at weeks 4 and 24; and other AA-specific health-related quality of life measures at week 24. Results A total of 1399 patients were randomized (mean [range] age, 36 [12-64] years; 826 female [59.0%]), 676 patients from the UP-AA1 and 723 patients from the UP-AA2, to either 15-mg upadacitinib (270 and 289 patients, respectively), 30-mg upadacitinib (271 and 289), or placebo (135 and 145). Their mean (SD) SALT score was 83.9 (18.9) at baseline. The proportion of patients who achieved SALT score of 20 or less at week 24 was significantly higher for the 15-mg upadacitinib (122 [45.2%] and 129 [44.6%]) and the 30-mg upadacitinib (149 [55.0%] and 157 [54.3%]) groups, respectively, than for the placebo (2 [1.5%] and 5 [3.4%]) group. The safety profile of both doses was similar in adults and adolescents and consistent with approved indications; no new safety findings were identified. Treatment-emergent adverse events reported by more than 5% of patients in any treatment group were upper respiratory tract infection, acne, elevated blood creatine phosphokinase, and nasopharyngitis. Across both studies, treatment-emergent serious adverse events occurred in 9 (1.6%), 13 (2.3%), and 1 (0.4%) of patients receiving 15-mg upadacitinib , 30-mg upadacitinib, or placebo, respectively. Conclusions and Relevance In these 2 parallel phase 3 replicate randomized clinical trials, upadacitinib demonstrated a positive benefit-risk profile in adults and adolescents with severe AA. Upadacitinib may be a potentially effective treatment option for this patient population. Trial Registration ClinicalTrials.gov Identifier: NCT06012240

2596 Background: No FDA approved nonsurgical therapies exist for primary nBCC at high-risk sites, e.g., H-zone, representing a significant unmet medical need. Recombinant IFN-alfa-2b previously achieved ∼85% complete histologic clearance in superficial and nBCC, but required multiple (9-12) injections and was associated with systemic toxicity. SP-002 encodes human IFN-γ and enables sustained, localized cytokine expression with anti tumor activity, achieved with a once weekly, three dose regimen that demonstrates a superior therapeutic index. Methods: Two early phase clinical studies of SP-002 in nBCC were completed: a single lesion study (ASN-002-001, NCT02550678, n=16), and a combination multilesion study with 4 weeks of vismodegib (ASN-002-003, NCT04416516, n=21, 46 lesions). Pretreatment biopsies from ASN-002-001 served as discovery specimens, while pretreatment biopsies from ASN-002-003 were prospectively assessed by central review for adnexal features (AdnF; follicular or eccrine differentiation) using standardized criteria. Post-treatement excision specimens were evaluated by local histopathology laboratories for CHC per protocol-defined criteria. CHC rates were calculated by AdnF. Results: ASN-002-001: sporadic low frequency/risk BCC, AdnF(+) rate was 20%. CHC rates were 33% (5e10vp), 83% (1.5 and 3.0e11vp). ASN-002-003: high-frequency multilesion BCC, AdnF(+) rate was ∼50%. CHC rates were 75% (1 nBCC)/52.9% (3 nBCC) (1.0e11vp) and 52.4% (3 nBCC) (1.5e11vp)-ITT. When analyzed by AdnF status, CHC rates were 97% in AdnF(-) lesions and 11.5% in AdnF(+) lesions. Baseline biopsies in non-responders demonstrated follicular/eccrine structures especially papillary mesenchymal bodies, harboring CKT15(+) stem cells (SC) and nuclear β-catenin, indicating active WNT signaling. Dual repression of programmed cell death effectors, CASP8/RIPK3, was also observed at baseline in lesions with residual disease with focal loss or widespread loss across tumor islands in β-catenin active regions. Either or both CASP8/RIPK3 were present in all complete responders at baseline and their absence may indicate risk for incomplete response to SP-002. Conclusions: SP-002 achieved high CHC rates at doses of 1.5e11vp/3.0e11vp and AdnF(-) lesions (most nBCC) had clearance rates comparable to surgical excision (>90%).Adnexal differentiation identifies a biologically distinct, treatment-resistant subset with WNT pathway activation, adnexal niches harboring CKT15(+) SC, and impaired IFN-γ cell death. These findings support AdnF as a predictive biomarker and position SP-002 as a promising non-surgical option for selected patients with nBCC. Clinical trial information: NCT02550678 , NCT04416516 . CHC rate AdnF(-)n/N lesions (%) CHC rate AdnF(+)n/N lesions (%) ASN-002-001 (n=15, 15 lesions) 11/12 (91.6%) 0/3 (0%) ASN-002-003 (n=21, 46 lesions) 23/23 (100%) 3/23 (13%) 34/35 (97.1%) 3/26 (11.5%)

BACKGROUND:JADE REAL was a global, prospective, multicenter, open-label expanded access protocol study that integrated the rigorous follow-up, safety, and efficacy assessments of a clinical trial with dosing flexibility and ability to use concomitant topical therapies to simulate real-world management of atopic dermatitis (AD). OBJECTIVE:The study aimed to provide access to abrocitinib for patients with moderate-to-severe AD without adequate treatments available. METHODS:Eligible patients received abrocitinib 100 mg or 200 mg once daily per investigator's discretion. Dose could be adjusted during treatment. Safety and exploratory efficacy endpoints were assessed. RESULTS:Of 312 patients, 120 (38.5%) and 192 (61.5%) received an initial dose of abrocitinib 100 mg and 200 mg, respectively. TEAEs were reported in 78.2% of patients. TEAEs led to dose change in 39 patients (12.5%); 12 (3.8%) had a dose escalation and 27 (8.7%) had a dose reduction. Rapid improvements in AD severity progressed up to 72 weeks among observed patients. CONCLUSION:Most patients continued their initial dose of abrocitinib. TEAEs accounted for a minority of documented dose reductions; instead, investigators may have determined that the patients' disease could be maintained at a lower dose. These findings support clinical decision-making around dose selection and modification. TRIAL REGISTRATION:NCT04564755.

The ALLEGRO phase 2a and 2b/3 studies demonstrated that ritlecitinib, an oral JAK3/TEC family kinase inhibitor, is efficacious at doses of ≥ 30 mg in patients aged ≥ 12 years with alopecia areata (AA). The objective of this study was to evaluate the safety of ritlecitinib in an integrated analysis of four studies in AA. Two cohorts were analyzed: a placebo-controlled and an all-exposure cohort. Proportions and study size–adjusted incidence rates (IRs) of adverse events (AEs) of interest and laboratory abnormalities are reported. In the placebo-controlled cohort (n = 881; median exposure: 169 days), the proportion of ritlecitinib-treated patients with AEs was 70.2–75.4

New targeted therapeutic approaches (eg. biologics, small molecules) have significantly changed the management of inflammatory dermatology conditions in recent years. Alopecia areata (AA), a non-scarring autoimmune hair loss condition, is one of the latest diseases to benefit from these developments. Here we review traditional, new and evolving therapies for AA and highlight the benefits, challenges and uncertainties that come with these new options. We present various real-world data collection approaches currently available and introduce GRASS-UK/GRASS-International as a global collaborative network of prospective AA disease registers designed to study the longer-term safety and effectiveness of new AA therapies as they are introduced.

BACKGROUND:Transgender people receiving testosterone may experience androgenetic alopecia. Treatments such as 5α-reductase inhibitors can interfere with masculinization. OBJECTIVE:To assess the efficacy and safety of sublingual minoxidil in the treatment of mild androgenetic alopecia in transgender people receiving full-dose testosterone therapy. METHODS:Participants were randomized 1:1 to receive either sublingual minoxidil 1.35 mg twice daily or placebo for 24 weeks; all received sublingual minoxidil 2.5 mg twice daily in an open-label extension phase. Tattoo-directed phototrichograms were performed. Co-primary endpoints were change in midfrontal and vertex target area hair count. RESULTS:Forty-six participants were randomized (23 per arm). At Week 24, midfrontal target area hair count improved by +15.7 hairs/cm2 with minoxidil vs placebo (P = .03) but no difference observed in the vertex. In the exploratory open-label phase, net midfrontal improvement from Week 0 to 48 was +12.3 hairs/cm2 (P = .02) and significant gains in the vertex occurred by Week 48 compared to baseline (+37.9 hairs/cm2, P = .009). Minoxidil was well tolerated, with no effect on testosterone concentrations or serious adverse events. LIMITATIONS:Mild baseline androgenetic alopecia may have reduced detection of change in global photographs and quality-of-life scores. CONCLUSIONS:Sublingual minoxidil was an effective and well tolerated option in this population for promoting hair growth in trans people receiving testosterone.

A 10-year-old boy was referred with progressive, diffuse balding of the scalp and abnormal dentition with conical incisors consistent with ectodermal dysplasia. Treatment was commenced with sublingual minoxidil, which he tolerated without any side effects. At 4 months, his hair shedding assessment grade had reduced from grade 5 to grade 3 according to the Sinclair Hair Shedding Visual Scale, and the patient reported increased hair density.

Importance:Alopecia areata (AA) is a chronic, systemic immune-mediated disease characterized by nonscarring hair loss. Many patients do not experience improvements with available treatment options and only ritlecitinib is approved for adolescent patients; therefore, there remains a clear unmet need for additional and improved systemic therapies. Objective:To evaluate the efficacy and safety of upadacitinib-an oral selective Janus kinase inhibitor-in adult and adolescent patients with severe AA. Design, Setting, and Participants:This global clinical program included 2 parallel phase 3 replicate randomized clinical trials (UP-AA1 and UP-AA2) conducted from October 2023 to July 2025, to evaluate upadacitinib in adolescent and adult patients (age 12 to <64 years old) with severe AA, defined as a Severity of Alopecia Tool (SALT) score of 50 or greater. Both trials included a 24-week placebo-controlled, double-blinded treatment period (period A) and a 28-week blinded extension treatment period (period B). Data were analyzed from July 2025 to October 2025. Interventions:Eligible patients were randomized 2:2:1 to once daily 15- or 30-mg upadacitinib or matching placebo. Main Outcomes and Measures:Achievement of (multiplicity controlled) SALT score of 20 or less at week 24. Multiplicity-controlled secondary efficacy end points included achievement of improvements in clinician-reported outcomes for eyebrows and eyelashes; achievement of SALT scores of 20 or less at weeks 4, 8, and 12; achievement of SALT score of 10 or less; SALT score 0 at week 24; patients' global impression of change of AA score of much better or moderately better at weeks 4 and 24; and other AA-specific health-related quality of life measures at week 24. Results:A total of 1399 patients were randomized (mean [range] age, 36 [12-64] years; 826 female [59.0%]), 676 patients from the UP-AA1 and 723 patients from the UP-AA2, to either 15-mg upadacitinib (270 and 289 patients, respectively), 30-mg upadacitinib (271 and 289), or placebo (135 and 145). Their mean (SD) SALT score was 83.9 (18.9) at baseline. The proportion of patients who achieved SALT score of 20 or less at week 24 was significantly higher for the 15-mg upadacitinib (122 [45.2%] and 129 [44.6%]) and the 30-mg upadacitinib (149 [55.0%] and 157 [54.3%]) groups, respectively, than for the placebo (2 [1.5%] and 5 [3.4%]) group. The safety profile of both doses was similar in adults and adolescents and consistent with approved indications; no new safety findings were identified. Treatment-emergent adverse events reported by more than 5% of patients in any treatment group were upper respiratory tract infection, acne, elevated blood creatine phosphokinase, and nasopharyngitis. Across both studies, treatment-emergent serious adverse events occurred in 9 (1.6%), 13 (2.3%), and 1 (0.4%) of patients receiving 15-mg upadacitinib , 30-mg upadacitinib, or placebo, respectively. Conclusions and Relevance:In these 2 parallel phase 3 replicate randomized clinical trials, upadacitinib demonstrated a positive benefit-risk profile in adults and adolescents with severe AA. Upadacitinib may be a potentially effective treatment option for this patient population. Trial Registration:ClinicalTrials.gov Identifier: NCT06012240.

Scalp hair regrowth in severe alopecia areata (AA) can occur rapidly or take up to 2 years in some patients. Baseline factors influence the likelihood and/or timing of treatment response with Janus kinase inhibitors. We evaluated initial evidence of improvement (Severity of Alopecia Tool30) and subsequent treatment success (SALT score ≤ 20) in four subgroups defined by baseline disease severity and AA episode duration to inform the treatment length required before assessing failure, based on disease presentation. In a post hoc analysis of BRAVE-AA1/2 (NCT03570749/NCT03899259), baricitinib 4 mg treatment subgroups were assessed for SALT30 and subsequent SALT score ≤ 20 over time. In severe AA (SALT score 50–94), SALT30 occurred in 70

Condition-specific outcome measure instruments (OMIs) are essential for assessing severity and evaluating response to emerging treatments. This scoping review identified OMIs used in assessing and treating androgenetic alopecia (AGA). Among 317 studies involving 194,158 individuals, 12 clinician-reported OMIs were identified, used in 51.7% of studies, including 31% of clinical trials. Hamilton-Norwood (23.9%) and Ludwig (20%) were the most used ClinROMs in AGA clinical trials, for male-pattern and female-pattern hair loss, respectively. The Men Hair Growth Questionnaire (MHGQ) was the most frequently used patient-reported severity assessment instrument in clinical trials (4.1%). The Women's Androgenetic Alopecia Quality of Life (WAA-QoL) and Hairdex were the only identified HRQoL instruments, used in 5.9% and 1.4% of clinical trials, respectively. Condition-specific OMIs are inconsistently applied across AGA clinical trials. Patient-reported instruments have remained underutilized. Our results underscore the need for consensus-based harmonization towards standardized assessment of AGA. Psychometric evaluation of existing instruments is also essential.

BACKGROUND:Fibrosing alopecia in a pattern distribution (FAPD) is a lymphocytic primary cicatricial alopecia first described in 2000. However, to date, the FAPD literature remains sparse. OBJECTIVES:To identify clinicopathological features and treatment outcomes of FAPD in a large multicentre cohort. METHODS:Patients who had biopsy-proven FAPD were selected from nine specialist hair clinics and were reviewed retrospectively to evaluate the clinical pattern of hair loss, trichoscopic and histopathological features, and response to treatment. RESULTS:Of 110 patients, with a mean age of onset of 52.5 (SD 14.8) years, 94 (85.5%) were women. The most common trichoscopic findings were loss of follicular ostia (97.2%, 103/106) and anisotrichia (97%, 84/87). Histopathological examination revealed perifollicular lymphocytic infiltration in 96.1% (99/103) and concentric lamellar fibrosis in 97% (92/95). After a median duration of treatment of 24 [interquartile range (IQR) 13-50] months, there was stabilization in hair density [median Sinclair grade 3.0 (IQR 3.0-4.0) pretreatment vs. 3.0 (IQR 2.0-4.0) post-treatment, P = 0.62]. Out of the 42 patients who received treatment for ≥ 12 months, 23 achieved stabilization and 16 demonstrated improvement in hair density. CONCLUSIONS:Limitations of the study include its retrospective design and disparate treatments. FAPD may be prone to misdiagnosis because of overlapping clinicopathological features with androgenetic alopecia. A combination of anti-inflammatory (for example, topical corticosteroids) and hair growth-promoting agents (for example, topical or low-dose oral minoxidil) can stabilize the condition or even promote hair regrowth.

BACKGROUND:Telogen effluvium (TE) is defined by an increased ratio of hairs in telogen to hairs in anagen. Diagnosis is not contingent on a self-reported quantum of telogen shedding. Androgenetic alopecia (AGA) is diagnosed histologically by follicular miniaturization. TE and AGA can both produce balding; however, their relative contributions and the sequence of these events are unknown. OBJECTIVES:To correlate individual fibre diameter (a proxy for follicular miniaturization) with anagen and telogen duration to determine whether TE precedes or follows AGA. METHODS:Healthy men aged 18-55 years with stage 3-5 vertex balding had serial tattoo-directed phototrichograms on days 1, 84 and 112. Individual hairs were tracked with computer-assisted hair-to-hair matching. Fibre diameter was measured. Anagen and telogen duration were mathematically calculated using the fraction of anagen and telogen hairs that remained in the same cycle phase between follow-up examinations. RESULTS:There was a linear correlation between fibre diameter and anagen duration. Thin fibres (60 µm) had a shortened mean (SD) anagen duration of 200 (72) days. In balding scalps, thick anagen fibres (> 80 µm) also had a shortened mean anagen duration of 580 (150) days. Telogen duration did not vary with fibre diameter. CONCLUSIONS:In men, a shortening of anagen duration precedes fibre diameter reduction. The clinical correlate of anagen shortening is TE, while reduction in fibre diameter correlates with follicle miniaturization and AGA. While visible TE occurs years in advance of visible balding in women with long hair, TE may go unnoticed in men with short hair. The observed sequence of events establishes that TE is a precursor to AGA. Failure to observe shedding does not negate a diagnosis of TE. We have developed a new model to describe the pathogenesis of balding.

BACKGROUND:Chronic persistent alopecia areata (CPAA), defined by an episode duration > 12 months, tends not to remit spontaneously and patients with CPAA are candidates for systemic therapy. The burden of CPAA is not entirely explained by the severity of scalp hair loss. CPAA widely affects physical and psychosocial aspects of health and wellbeing. Exploring patients' perspectives on these domains of impact among those commencing systemic treatments will shed light on patient expectations from systemic treatments and the most relevant patient-reported outcomes. OBJECTIVES:To understand patients' perspectives on the key impact domains of CPAA that are the most important motives for patients when deciding whether to commence a systemic therapy. METHODS:Patients receiving systemic therapy for CPAA who completed an online survey that included two patient-reported questionnaires, the Assessment of Quality of Life-8 Dimensions (AQoL-8D) and the Alopecia Areata Patient Priority Outcome (AAPPO), were invited to participate in a focus group to explore the key impact domains of AA, beyond scalp hair loss severity, that had led them to commence systemic therapy. Focus group discussions were transcribed and thematically analysed using NVivo v14. Quantitative data were analysed using SPSS v26. RESULTS:Quantitative data (n = 44 online surveys) revealed significant impairment in psychosocial dimensions, contrary to physical dimensions, in our patients, based on the AQoL-8D. None of the health-related quality of life (HRQoL) dimensions were associated with the extent of scalp hair loss, assessed by the AAPPO. Focus group participants (n = 31) revealed AA-related physical and psychosocial priorities, which emerged as 13 subthemes within three main themes: physical, psycho-emotional and social. Eyelash and eyebrow appearance were the most frequent physical impacts. A sense of frustration and/or despair and the impact of long-term camouflaging in social activities were the most frequent subthemes within their attributed themes. CONCLUSIONS:Facial hair loss and various psychosocial domains of HRQoL are key impact domains of AA, other than scalp hair loss, in patients commencing systemic treatments. Perceived domains that were considered important by patients can serve as a foundation of patient-centred criteria of candidacy for systemic treatments, contributing to the timely initiation of systemic treatments in patients suffering from considerable disease burden. Further research should aim at the integration of our findings into the clinical setting.

Importance:Currently, there are no standardized outcome domains or measures in clinical trials for facial aging. Heterogeneity in outcome domains and measurement instruments across clinical trials creates difficulty in directly comparing interventions, determining superior therapies, and developing high-quality meta-analyses. Objective:To develop a core outcome set (COS) of essential domains to be reported in clinical trials evaluating the efficacy of interventions for facial aging. Evidence Review:PubMed/Medline, Embase, Cochrane Central Register of Controlled Trials, and CINAHL were searched from September 2005 to September 2015. An updated search of the same databases was performed from September 2015 to February 2026. Studies were included if (1) they were randomized clinical trial or controlled clinical trial in design, (2) they assessed the efficacy or safety of an intervention for facial aging, (3) they were published in English, and (4) they involved human participants. Complementary sources, including patient interviews, were used to capture further relevant outcomes. Two rounds of Delphi surveys, followed by consensus meetings, were used to identify outcome domains considered most important by both patient and physician stakeholders. Findings:The final COS consists of 6 outcome domains: (1) overall convenience of treatment; (2) time to return to normal work and social activity; (3) overall assessment of focused area of treatment (at the point in time when treatment is expected to provide peak benefit); (4) duration of treatment effect; (5) severity of persistent local or systemic adverse events, including pigmentary change, skin texture change, delayed healing, scarring, and serious adverse events; and (6) patient satisfaction with treatment. Conclusions and Relevance:The 6 outcome domains identified through a Delphi consensus are recommended for reporting in future facial aging trials to ensure that outcomes that matter most to patients and clinicians are measured and that results are comparable across interventions.

Ritlecitinib is an oral, selective inhibitor of JAK3 and TEC family kinases under investigation for the treatment of nonsegmental vitiligo (NSV). In a phase 2b study, ritlecitinib was efficacious and well tolerated over 48 weeks. The Tranquillo phase 3 program comprises three studies aiming to evaluate the efficacy, safety, and tolerability of once-daily 50-mg and 100-mg ritlecitinib in adult and adolescent patients with NSV. Tranquillo (NCT05583526), a randomized, double-blind, placebo-controlled 52-week trial, compares the efficacy and safety of once-daily 50-mg ritlecitinib vs placebo (N ≈ 600). Tranquillo LTE (NCT06163326), a randomized, double-blind, withdrawal and dose-up titration 52-week extension study, investigates the safety, tolerability, and efficacy of once-daily 50-mg and 100-mg ritlecitinib and durability of response with once-daily 50-mg ritlecitinib following participation in Tranquillo (N ≈ 400). Tranquillo 2 (NCT06072183) comprises two parts: Part I, a 52-week randomized, double-blind, placebo-controlled study with 52-week extension with randomized dose-up/dose-down titration comparing once-daily 50-mg and 100-mg ritlecitinib with placebo (N ≈ 1000), and Part II, a de novo 52-week nonrandomized, open-label once-daily 100-mg ritlecitinib arm (N ≈ 450). Participants are aged ≥ 12 years (Tranquillo 2: ≥ 18 years) with clinical diagnosis of active or stable NSV for ≥ 3 months, body surface area involvement 4