NCT07335588

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

A Phase 3, Double-blinded, Vehicle-controlled Trial to Investigate the Efficacy and Safety of Twice Daily Delgocitinib Cream in Adult Participants With Lichen Sclerosus During a 12-Week Initial Treatment Period Followed by a 40-Week Continuation Treatment Period

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 652 (estimated)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lichen Sclerosus

Interventions

Type	Name	Description
DRUG	Delgocitinib	Participants will receive delgocitinib BID via topical application.
DRUG	Cream Vehicle	Participants will receive cream vehicle BID via topical administration.

Timeline

• Start date: 2026-05-06
• Primary completion: 2028-03-10
• Completion: 2028-12-29
• First posted: 2026-01-13
• Last updated: 2026-02-20

Regulatory

• FDA-regulated drug study