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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT07335588

Public ClinicalTrials.gov record NCT07335588. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 27, 2026, 12:55 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07335588
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
LEO Pharma
Industry
Enrollment
652 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 1, 2026 (Actual)
Primary completion
Mar 10, 2028 (Estimated)
Completion
Dec 29, 2028 (Estimated)
Last update posted
Oct 13, 2026

2026 – 2028

United States locations

U.S. sites
20
U.S. states
14
U.S. cities
19
Facility City State ZIP Site status
LEO Pharma Investigational Site Birmingham Alabama 35244 Recruiting
LEO Pharma Investigational Site Phoenix Arizona 85006 Recruiting
LEO Pharma Investigational Site Scottsdale Arizona 85259 Recruiting
LEO Pharma Investigational Site Fremont California 94538 Recruiting
LEO Pharma Investigational Site Middlebury Connecticut 06762 Recruiting
LEO Pharma Investigational Site Washington D.C. District of Columbia 20037 Recruiting
LEO Pharma Investigational Site Boca Raton Florida 33486 Recruiting
LEO Pharma Investigational Site Clearwater Florida 33756 Recruiting
LEO Pharma Investigational Site Jacksonville Florida 32224 Recruiting
LEO Pharma Investigational Site Miami Florida 33186 Recruiting
LEO Pharma Investigational Site Tampa Florida 33609 Recruiting
LEO Pharma Investigational Site Northville Michigan 48167 Recruiting
LEO Pharma Investigational Site Rochester Minnesota 55905 Recruiting
LEO Pharma Investigational Site New York New York 10029 Recruiting
LEO Pharma Investigational Site New York New York 10036 Recruiting
LEO Pharma Investigational Site Chapel Hill North Carolina 27516 Recruiting
LEO Pharma Investigational Site Bexley Ohio 43209 Recruiting
LEO Pharma Investigational Site Portland Oregon 97239 Recruiting
LEO Pharma Investigational Site Dallas Texas 75235 Recruiting
LEO Pharma Investigational Site Murray Utah 84107 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07335588, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 13, 2026 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07335588 live on ClinicalTrials.gov.

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