Phase 3 Study of Twice Daily Delgocitinib Cream for Treating Mild to Severe Lichen Sclerosus in Adults Initial 12-Week Treatment Followed by 40-Week Continuation

What this Trial Is About

Researchers are evaluating the effectiveness of delgocitinib cream applied twice daily compared to a cream vehicle for treating adults with mild to severe lichen sclerosus LS, a skin condition affecting mostly females in the anogenital area. The study is conducted in two parts Part 1 enrolls female participants to determine the best dose, and Part 2 includes both female and male participants to further assess the chosen dose and safety in males. Participants receive different dosing regimens of delgocitinib cream or cream vehicle applied twice daily during a 12-week initial treatment period, followed by a 40-week continuation treatment period. Different groups receive varying doses or sequences of delgocitinib cream and cream vehicle to compare effects. A substudy evaluates male participants separately to assess safety and efficacy. During the trial lasting between 55 and 60 weeks, participants undergo regular assessments including clinical evaluations of LS severity using IGA-LS scores, pain and itch numerical rating scales, and quality of life indexes. Safety is monitored through adverse event tracking and laboratory tests. The main outcome measured is the number of participants achieving a specific improvement in LS severity at Week 12, with additional evaluations continuing through Week 52.

A 52-Week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream in Adult Participants With Lichen Sclerosus