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Study identifier: NCT07335588 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Lichen Sclerosus  ·  Sponsor: LEO Pharma

PhasePhase 3
Planned participants652
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Clinical Disclosure  ·  (+45) 4494 5888  ·  disclosure@leo-pharma.com

Always discuss trial participation with your own doctor first.

Locations (7)

LEO Pharma Investigational SiteBirmingham, Alabama, United StatesRecruiting
LEO Pharma Investigational SiteWashington D.C., District of Columbia, United StatesRecruiting
LEO Pharma Investigational SiteMiami, Florida, United StatesRecruiting
LEO Pharma Investigational SiteTamarac, Florida, United StatesRecruiting
LEO Pharma Investigational SiteNew York, New York, United StatesRecruiting
LEO Pharma Investigational SiteMontreal, Quebec, CanadaRecruiting
LEO Pharma Investigational SiteQuébec, Quebec, CanadaRecruiting

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Source record: clinicaltrials.gov/study/NCT07335588