Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over an 8-week Treatment Period in Adult Subjects With Atopic Dermatitis.
NCT03725722 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 251
Last updated 2025-03-12
Summary
This is a double-blind, multi-centre, randomised, 5-arm, vehicle-controlled, parallel-group trial. The trial is designed to establish a dose-response signal and investigate the efficacy and safety of delgocitinib cream in the treatment of adult subjects with mild to severe atopic dermatitis (AD).
Conditions
Interventions
- DRUG
-
Delgocitinib cream
Cream for topical application
- DRUG
-
Delgocitinib cream vehicle
The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Sponsors & Collaborators
-
LEO Pharma
lead INDUSTRY
Principal Investigators
-
Medical Expert · LEO Pharma
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-12-28
- Primary Completion
- 2020-05-19
- Completion
- 2020-05-19
- FDA Drug
- Yes
Countries
- United States
- Australia
- Canada
Study Locations
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