Background Content valid and clinically meaningful instruments are required to evaluate outcomes of therapeutic interventions in alopecia areata (AA). Objective To develop an investigator global assessment (IGA) to interpret treatment response in AA treatment studies. Methods Qualitative interviews were conducted in the US with expert dermatologists and AA patients who had experienced ≥50% scalp hair loss. Thematic data analysis identified critical outcomes and evaluated the content validity of the new IGA. Results Expert clinicians (n=10) judged AA treatment success by the amount of scalp hair growth (median 80% scalp hair). Adult (n=25) and adolescent (n=5) patients participated. Scalp hair loss was the most bothersome AA sign/symptom to most patients. Perceived treatment success ‐‐ short of 100% scalp hair ‐‐ was the presence of ~70‐90% scalp hair (median 80%). Using additional clinician and patient insights, the AA‐IGA™ was developed as an ordinal, static measure comprising five severity categories of the Severity of Alopecia Tool (SALT) 0‐100% scores. Nearly all queried clinicians and patients in this study agreed that for patients with ≥ 50% scalp hair loss, successful treatment would be hair regrowth resulting in ≤ 20% scalp hair loss, and supported the AA‐IGA™ as a meaningful clinician‐reported measure for this patient population. Conclusions We recommend the use of the SALT to assess the extent (0‐100%) of scalp hair loss. Using the SALT assessment, the AA‐IGA™ is a robust ordinal measure providing distinct and clinically meaningful gradations of scalp hair loss that reflects patients’ and expert clinicians’ perspectives and treatment expectations.

Alopecia areata (AA) is a hair loss disorder that can seriously impact quality of life. Janus kinase (JAK) inhibitors, including deuruxolitinib, have previously demonstrated significant hair regrowth in AA. The Phase 3 THRIVE-AA1 randomized, double-blinded, placebo-controlled trial (NCT04518995) evaluated safety and efficacy of the oral JAK1/JAK2 inhibitor deuruxolitinib in adult patients with AA. Patients aged 18-65 years with ≥50% hair loss were randomized to deuruxolitinib 8 mg BID, deuruxolitinib 12 mg BID, or placebo for 24 weeks. The primary endpoint was percentage of patients achieving Severity of Alopecia Tool (SALT) score ≤20. A key secondary endpoint was percentage of satisfaction of hair patient-reported outcome (SPRO) responders. Significantly higher proportions of patients taking deuruxolitinib met the primary endpoint (8 mg 29.6%; 12 mg 41.5% versus placebo 0.8%). Both deuruxolitinib doses achieved significant improvements in all secondary endpoints versus placebo, including SPRO (8 mg 42.1%; 12 mg 53.0% versus placebo 4.7%). Most treatment-emergent adverse events were mild or moderate, consistent with other oral JAK inhibitors. Further studies are required to understand longer-term safety, efficacy, and impact of treatment cessation. Both doses of deuruxolitinib were effective for hair regrowth. Patient satisfaction aligned with hair growth.

Background: Alopecia areata (AA) is characterized by hair loss that can affect the scalp and body. This study describes the psychosocial burden of AA. Methods: Participants diagnosed with AA who had experienced ≥50% scalp hair loss according to the Severity of Alopecia Tool (SALT) were identified by clinicians. A semi-structured interview guide, developed with expert clinician input, included open-ended questions to explore patients’ experiences of living with AA. Data were thematically analyzed to identify concepts and relationships. Results: Participants (n = 45, 58% female, mean age 33.3 years [range 15–72], mean SALT 67.2 [range 0–100]) described the AA diagnosis as “devastating”. Both males and females reported emotional and psychological impacts of AA including feeling sad/depressed (n = 21), embarrassed/ashamed (n = 10) and angry/frustrated (n = 3). Patients felt helpless (n = 5) due to the unpredictability of disease recurrence, and anxious (n = 19) about judgement from others. Many patients avoided social situations (n = 18), which impaired relationships and increased isolation. Coping strategies included concealment of hair loss through wigs or make-up, although fear of the displacement of these coverings also caused anxiety and the avoidance of activities that could result in scalp exposure (n = 22). Some patients became more accepting of AA over time, which lessened the emotional impact, though efficacious treatment was still desired. A conceptual framework was developed, and a conceptual model was created to depict the relationship between the physical signs/symptoms and the associated psychosocial effects of AA. Conclusion: AA impairs patients’ emotional and psychological wellbeing, relationships and lifestyles. Greater disease awareness and effective treatments are needed.

Introduction: Although labeling changes and market withdrawal have been implemented for oral ketoconazole (KTZ) due to serious adverse effects (AEs), topical KTZ is generally thought to be effective and safe for the treatment of superficial fungal infections. New dermatologic indications for the use of topical KTZ have arisen such as onychomycosis, blepharitis, and hair loss. This article aims to review the literature on topical KTZ's efficacy and AEs, as well as provide an overview on current insights regarding its mechanism of action and upcoming developments. Methods: A PubMed search was done to include randomized controlled trials (RCTs) focusing on the use of topical KTZ in human subjects. Results: Forty studies with 4566 patients were included in this review. Topical KTZ is clinically effective for the treatment of Malassezia-related conditions such as seborrheic dermatitis (SD) and pityriasis versicolor (PV) with a reported efficacy of 63-90% and 71-89%, respectively. Conclusions: Topical KTZ demonstrates high clinical efficacy for Malassezia-related conditions. More efficacious alternatives are now available for Tinea and Candida. Although topical KTZ is safe, clinicians should be aware that allergic contact dermatitis may occur. Further studies should be completed to investigate the use of topical KTZ for hair loss and inflammatory dermatoses.