Effect of LEO 39652 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)

Phase 1

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: LEO 39652 cream

• Registration Number: NCT02219633
• Lead Sponsor: LEO Pharma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-13
• Study First Submitted QC: 2014-08-15
• Study First Posted: 2014-08-19
• Primary Completion: 2014-12
• Study Completion: 2015-01
• Status Verified: 2016-06
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LEO 39652 cream	LEO 39652 cream	Topical application
LEO 39652 cream vehicle	LEO 39652 cream	Topical application

Primary Outcome Measures

Name	Time	Method
Total sign score at end of treatment	22 days	Total Sign Score is defined as the sum of severity scores (4-point scale) of the Individual Sign Scores(erythema, edema/papulation, oozing/crusting, excoriations, lichenification and dryness)for each assessed area.

Secondary Outcome Measures

Name	Time	Method
Total sign score on limited treatment area	22 days
Investigator's treatment area assessment of disease severity	22 days
Subject´s treatment area assessment of disease severity	22 days
Subject´s assessment of itching	22 days
Transepidermal Water Loss	22 days

Trial Locations

Locations (1)

proinnovera GmbH, Center of Dermatology Excellence; 🇩🇪 Münster, Germany