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

Study acronym: DELTA CARE 1
StatusRecruiting
PhasePhase 3
SponsorLEO Pharma
Started
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Record History

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  1. Trial sites expanded: 25 → 33 locations
  2. Eligibility criteria expanded, about 52 words
    • Site details revised at 1 of 25 sites
  3. Trial sites expanded: 16 → 25 locationsv7
  4. Trial sites expanded: 7 → 16 locationsv6
  5. Trial sites expanded: 3 → 7 locationsv5
  6. Recruitment opened
    • Trial sites expanded: 0 → 3 locations
    • Start date changed from estimate of May 6, 2026 to May 1, 2026
    v4
  7. Re-verified, no change to tracked fieldsv3
  8. Study title expanded, about 3 wordsv2
  9. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
LEO Pharma
25 trials monitored
See all monitored trials
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.
Trial Details
NCT Number NCT07335588
Lead Sponsor LEO Pharma
Conditions
(from sponsor)		 Lichen Sclerosus
Related terms Lichen Sclerosus et Atrophicus
Enrollment 652 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov