Status:
COMPLETED
Effect of LEO 39652 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)
Lead Sponsor:
LEO Pharma
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The aim of this trial is to assess the efficacy of LEO 39652 cream compared with LEO 39652 cream vehicle in adults with mild to moderate AD after 3 weeks of treatment.
Eligibility Criteria
Inclusion
- Subjects with Atopic Dermatitis (AD) as defined by Hanifin and Rajka criteria and with mild to moderate disease severity (IGA 2 or 3)
- Two symmetrical and comparable Entire Treatment Areas, on the same body region (left and right part)
- Subjects must be in good health
- Female subjects of childbearing potential and male subjects must be willing to consent to using high effective methods of contraception
Exclusion
- Any condition in the treatment areas that in the opinion of the investigator could interfere with clinical assessments, e.g. acne, infection, rash (other than atopic dermatitis), sunburn, hyper-or hypopigmentation, scars
- Dark-skinned persons (i.e. skin type IV to VI according to Fitzpatrick classification system) whose skin colour prevents reliable clinical assessments
- Any permanent (or transient within 28 days prior to dosing) disease (in particular cardiac disease such as heart failure or history of myocardial infarction) that may interfere with the subjects safe participation in the trial, with the subjects ability to participate in the trial or with the clinical assessments
- Subjects with congenital or acquired immunodeficiencies or in subjects on therapy that causes immunosuppression
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02219633
Start Date
July 1 2014
End Date
January 1 2015
Last Update
February 24 2025
Active Locations (1)
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1
proinnovera GmbH, Center of Dermatology Excellence
Münster, Germany, 48159