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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 is a Phase 3 study that is actively recruiting participants, run by LEO Pharma. The registered enrollment target is 652 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07335588
The ClinicalTrials.gov registry entry for NCT07335588 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 652 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is LEO Pharma, which has 65 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Delgocitinib is the first listed.
NCT07335588 reports 0 study locations.
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.
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