Clinical Trial

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

Study acronym: DELTA CARE 1
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The main objective of the study is to evaluate the efficacy of twice daily applications of delgocitinib cream compared with cream vehicle in the treatment of adult participants with mild to severe lichen sclerosus (LS). The researchers are focusing on female participants because LS is more likely to affect females compared to males. The trial is conducted in 2 parts. Part 1 of the trial enrolls female participants with LS and results in the selection of the optimal dose for Part 2. The selected dose will then be evaluated in Part 2, which will enroll both female and male participants. Assessment of efficacy and safety of delgocitinib cream in male participants with LS will be evaluated in a substudy. For each participant, the trial will last at least 55 weeks and up to 60 weeks.
Protocol Amendment History 4 changes
notable Trial sites expanded: 7 -> 16 locations 2026-08-08
notable Trial sites expanded: 3 -> 7 locations 2026-06-10
critical Recruitment opened 2026-05-23
notable Trial sites expanded: 0 -> 3 locations 2026-05-23
Trial Details
NCT Number NCT07335588
Lead Sponsor LEO Pharma
Conditions Lichen Sclerosus
Enrollment 652 participants
Start Date 2026-05-01
Primary Completion 2028-03-10 (estimated)
Study Completion 2028-12-29 (estimated)
Updated on ClinicalTrials.gov 2026-08-07