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NCT07335588 · ClinicalTrials.gov registry record · Phase 3
A 52-Week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream in Adult Participants With Lichen Sclerosus
A Phase 3 study, sponsored by LEO Pharma.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 652
- Enrollment target
NCT07335588: Recruiting Phase 3 study, sponsored by LEO Pharma.
NCT07335588 is a Phase 3 study that is actively recruiting participants, run by LEO Pharma. The registered enrollment target is 652 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07335588, a Phase 3 study, is actively recruiting participants, sponsored by LEO Pharma.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 652 participants
- Enrollment target
Study 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.
Interventions
- DRUG Delgocitinib
- DRUG Cream Vehicle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 652 participants |
| Start Date | 2026-05-01 |
| Est. Completion | 2028-12-29 |
| Phase | Phase 3 |
What NCT07335588 shows while recruiting
NCT07335588 is an interventional study that assigns participants to a tested intervention. The registered 652 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower).
The record links to 0 conditions, and to 2 interventions - of which Delgocitinib is the first listed.
NCT07335588 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07335588 about?
NCT07335588 is a clinical study titled "A 52-Week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream in Adult Participants With Lichen Sclerosus". 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...
What is the current status of trial NCT07335588?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 652 participants. The study started on 2026-05-01. Estimated completion is 2028-12-29.
What interventions are being tested in trial NCT07335588?
The interventions under investigation include: Delgocitinib (DRUG), Cream Vehicle (DRUG).
Who is sponsoring clinical trial NCT07335588?
This trial is sponsored by LEO Pharma, which has 65 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07335588's enrollment target sits among peer trials
652 571st of 2000 higher than 1,429 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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