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A Phase 3, Double-blinded, Vehicle-controlled Trial to Investigate the Efficacy and Safety of Twice Daily Delgocitinib Cream in Adult Participants With Lichen Sclerosus During a 12-Week Initial Treatment Period Followed by a 40-Week Continuation Treatment Period
Led by LEO Pharma · Updated on 2026-05-22
652
Participants Needed
3
Research Sites
42 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of delgocitinib cream applied twice daily compared to a non-active cream (cream vehicle) in treating adults with mild to severe lichen sclerosus (LS), a skin condition mainly affecting females in the anogenital area. The study is conducted in two parts: Part 1 enrolls female participants to determine the best dose, and Part 2 will include both females and males to further assess efficacy and safety, including a substudy for males. This is a phase 3, double-blinded, vehicle-controlled trial led by LEO Pharma. Participants will be randomly assigned to receive different doses of delgocitinib cream (20 mg/g or 8 mg/g) or cream vehicle, applied twice daily during an initial 12-week treatment period. This is followed by a 40-week continuation period where participants may continue with the same treatment or switch between delgocitinib cream and cream vehicle depending on their assigned group. The trial includes multiple treatment arms to compare the effects of the cream at selected doses and vehicle over these periods. During the trial, participants will attend clinic visits for assessments of skin condition severity, pain, itch, and quality of life using specific scales such as IGA-LS, CLISSCO, Skin Pain Numerical Rating Scale, and Vulvar Quality of Life Index. Safety will be monitored through reports of adverse events and clinical evaluations. The total participation time for each individual ranges from 55 to 60 weeks, including both treatment periods and follow-up assessments.
CONDITIONS
Brief Title
A 52-Week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream in Adult Participants With Lichen Sclerosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent before any trial procedures
- Age 18 years or older at the time of consent
- Able to comply with clinic visits and trial requirements
- Female or male participants with lichen sclerosus in the anogenital area confirmed by biopsy
- Disease severity graded as mild to severe (IGA-LS score 652)
- Women of childbearing potential must agree to use effective birth control during the trial
You will not qualify if you...
- Uncertain diagnosis of lichen sclerosus or suspicion of malignancy in the anogenital area
- History of vulvar or penile squamous cell carcinoma or precursor lesions
- Female participants with abnormal cytology after positive high-risk HPV screening
- Active skin or gynecologic conditions that interfere with diagnosis or treatment assessment
- Severe urinary incontinence
- Active infections in the anogenital area unless treated and cleared before enrollment
- Significant infections within 4 weeks before baseline
- Known primary immunodeficiency or positive HIV test
- Major surgery within 8 weeks before screening or planned hospitalization during trial
- History of cancer not in remission or recent curative therapy less than required time
- Positive hepatitis B or C virus tests
- Known hypersensitivity to study treatment components
- Unstable disorders affecting safety or trial completion
- Clinically significant abnormal findings during screening
- Current or recent alcohol or drug abuse affecting compliance
- Pregnancy or lactation in female participants
- Recent use of immunosuppressive or immunomodulating drugs
- Recent use of Janus kinase inhibitors or topical corticosteroids/immunomodulators in the treatment area
- Recent use of systemic or topical anti-infective agents
- Recent use of biological therapies or investigational drugs
- Recent light-based or other cutaneous therapies in treatment area
- Recent surgical treatment for anogenital lichen sclerosus
- Unstable doses of topical estrogens or hormonal therapies in females
- Current participation in another interventional trial
- Previous randomization in this or a delgocitinib trial
- Clinically important liver or kidney function abnormalities
- Trial site employees or immediate family
- Legally institutionalized individuals
- Male participants needing surgical or tool-assisted treatment for lichen sclerosus in urethra during study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - 12 weeks
Participants apply delgocitinib cream or cream vehicle twice daily during the initial 12-week treatment period.
Regular visits during the initial 12 weeks to monitor treatment and safety
Duration - 40 weeks
Participants continue applying delgocitinib cream or cream vehicle twice daily during the 40-week continuation treatment period.
Regular visits during continuation period to monitor ongoing treatment and safety
Trial Site Locations
Total: 3 locations
1
LEO Pharma Investigational Site
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
2
LEO Pharma Investigational Site
Miami, Florida, United States, 33186
Actively Recruiting
3
LEO Pharma Investigational Site
New York, New York, United States, 10036
Actively Recruiting
Research Team
C
Clinical Disclosure
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
11
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