Health-related quality of life in mild-moderate patchy alopecia areata: Results from the first controlled Phase 2 clinical trial in this population with STS01 (dithranol/ProSilic) and challenges for the future
Fleet, D. M.; Messenger, A.; Bryden, A.; Harris, M. J.; Holmes, S.; Farrant, P.; Leaker, B.; Takwale, A.; Oakford, M.; Kaur, M.; Mowbray, M.; Macbeth, A.; Gangwani, P.; Gkini, M. A.; Jolliffe, V.
Show abstract
A phase 2, randomised, double-blind, placebo controlled trial has been conducted in mild to moderate patchy alopecia areata (AA). This demonstrated significant and dose related improvements in hair regrowth with STS01, a controlled release, topical formulation of dithranol. Here we report the results of the Alopecia Areata Symptom Impact Scale (AASIS) that assesses the severity of symptoms, daily functioning and feelings. Similar to trials in severe AA, significant improvements in hair regrowth did not translate into significant health-related quality of life (HRQoL) improvements, even in patients with complete hair regrowth, although there was some treatment-related correlation between changes in AASIS scores from baseline and clinical assessment SALT scores. The use of current HRQoL methods or indeed new measures in development for future trials, will have considerable challenges: patients may not have a true baseline at entry, may develop coping mechanisms, and there may be a delay between physical and psychological improvement.
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