Phase 2 trial: Topical STS01 shows dose-related hair regrowth in mild-moderate alopecia areata

A Phase 2 randomized controlled trial evaluated the topical formulation STS01 (dithranol/ProSilic) versus placebo in patients with mild to moderate patchy alopecia areata. The study found significant and dose-related improvements in hair regrowth with STS01 treatment. However, this clinical benefit did not lead to significant improvements in health-related quality of life (HRQoL) as measured by the Alopecia Areata Symptom Impact Scale (AASIS), even among patients who achieved complete hair regrowth. The analysis noted some treatment-related correlation between AASIS score changes and Severity of Alopecia Tool (SALT) scores.

Safety and tolerability data were not reported in the available evidence. The study's limitations include potential issues with establishing a true baseline at patient entry, the development of patient coping mechanisms that may affect HRQoL reporting, and a possible delay between physical and psychological improvement. The researchers also noted challenges with HRQoL measurement in this population.

As a Phase 2 trial, these results are preliminary and specific to patients with mild to moderate patchy disease. The dissociation between objective hair regrowth and patient-reported HRQoL outcomes highlights the complexity of assessing treatment benefit in alopecia areata. Further research is needed to confirm efficacy, establish safety, and better understand the relationship between clinical endpoints and patient experience.