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Delgocitinib Cream for Lichen Sclerosus

This study is testing a cream called delgocitinib to see how well and safely it treats lichen sclerosus (LS), a skin condition. Researchers will compare delgocitinib cream to a cream vehicle (a cream without the active medicine) applied twice a day. The main goal is to see how many participants achieve an improved score on a special assessment (IGA-LS TS) by Week 12. The study is open to adults aged 18 and older with mild to severe LS. Initially, it will focus on female participants to find the best dose, then expand to include both male and female participants. The study is currently unclear on its recruitment status.

Study design
This is an interventional study planning to enroll 652 participants. It will be conducted in two parts, with the first part focusing on female participants to determine the optimal dose.
What's involved
For each participant, the trial will last at least 55 weeks and up to 60 weeks. You would apply the assigned cream twice daily.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Week 12, but the trial duration for each participant is at least 55 weeks and up to 60 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07335588

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
LEO Pharma
~652 participants
Updated 2026-09-14 on ClinicalTrials.gov
What's tested:DelgocitinibCream Vehicle

At a glance

Recruiting sites
25 of 25 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Achieving IGA-LS TS at Week 12
Measured over Week 12

Conditions

Lichen Sclerosus

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NCT07335588

Where you'd take part

This study runs at 25 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • LEO Pharma Investigational Site

    Birmingham, Alabamano site contact published

    Recruiting

  • LEO Pharma Investigational Site

    Phoenix, Arizonano site contact published

    Recruiting

  • LEO Pharma Investigational Site

    Scottsdale, Arizonano site contact published

    Recruiting

  • LEO Pharma Investigational Site

    Fremont, Californiano site contact published

    Recruiting

  • LEO Pharma Investigational Site

    Washington D.C., District of Columbiano site contact published

    Recruiting

  • LEO Pharma Investigational Site

    Boca Raton, Floridano site contact published

    Recruiting

  • LEO Pharma Investigational Site

    Clearwater, Floridano site contact published

    Recruiting

  • LEO Pharma Investigational Site

    Miami, Floridano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Expert · STUDY_DIRECTOR · LEO Pharma

Who to contact

Clinical Disclosure
[email protected]
(+45) 4494 5888
Email the study team

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Eligibility criteria

Exclusion

A systemic infection.
A serious skin infection requiring parenteral (intravenous or intramuscular) antibiotics, antiviral, or antifungal medication. 8. History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus test at screening, or the participant taking antiretroviral medications as determined by medical history and/or participant's verbal report. 9. Major surgery within 8 weeks prior to screening or planned in-patient surgery or hospitalization during the trial period. 10. History of cancer:
Affect the safety of the participant throughout the trial.
Hinder the participant's ability to complete the trial.
Put the participant at risk because of their participation in the trial.
Influence the participant's ability to complete the trial.
Any cell-depleting agent including but not limited to rituximab: within 6 months prior to baseline, or until the lymphocyte count returns to normal, whichever is longer.
Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to baseline. 22. Treatment with any non-marketed drug substance (that is, an agent that has not yet been made available for clinical use following registration) within 4 weeks prior to baseline or 5 half-lives, whichever is longer. 23. Light-based therapy on the anogenital area and treatments with platelet-rich plasma within 4 weeks prior to baseline. 24. Cutaneous treatments applied within 1 week before baseline in regions other than the anogenital area which could interfere with clinical trial evaluations or pose a safety concern. 25. Other cutaneous therapies or therapeutic procedures on the anogenital area within 1 week before baseline. 26. Surgical treatment for anogenital LS in the past 6 months or have not recovered fully from an earlier surgical procedure in the anogenital area. 27. Female participants only: Participants who are receiving doses that are not stable for topical estrogens (\<4 weeks before screening), and hormonal contraceptives and hormone replacement therapy (HRT) medications (\<3 months before screening). 28. Current participation in any other interventional clinical trial. 29. Previously randomized in this clinical trial. 30. Previously randomized in a clinical trial with delgocitinib. 31. Clinically important laboratory abnormalities:
Participants with alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) values ≥2×the upper limit of normal (ULN) with total bilirubin (BIL) ≥1.5×ULN (unless elevated BIL is related to Gilbert Meulengracht Syndrome).
Participants with ALT and/or AST values ≥3×ULN.
Participants with severe renal impairment (estimated glomerular filtration rate \[eGFR\]\<30 mL/min/1.73 m2). 32. Employees of the trial site, or any other individuals directly involved with the planning or conduct of the trial, or immediate family members of such individuals. 33. Participants who are legally institutionalized. 34. Only applicable in France: Participant not affiliated with or not a beneficiary of a social security scheme. 35. Male participants only: Participants who currently need or are expected during the entire study period to require any type of surgical treatment for LS (eg, circumcision, urethroplasty, adhesiolysis) or tool-assisted local treatment (eg, catheter, cotton swabs, applicators, dilators, etc.) for LS involving the urethra. Application of study treatment of the urethral meatus is allowed if it can be applied by the participant's hand or fingers only.

What this trial measures

  • Number of Participants Achieving IGA-LS TS at Week 12Week 12