An Explorative Trial Evaluating the Effect of LEO 32731 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)

Phase 1

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: LEO 32731 cream; Drug: LEO 32731 cream vehicle

• Registration Number: NCT02496546
• Lead Sponsor: LEO Pharma

Brief Summary

The aim of this trial is to assess the efficacy of LEO 32731 cream 20 mg/g compared with LEO 32731 cream vehicle in adults with mild to moderate AD after 3 weeks of treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-09
• Study First Submitted QC: 2015-07-13
• Study First Posted: 2015-07-14
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

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

Inclusion Criteria

• Following verbal and written information about the trial, subjects must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial related procedures being carried out
• Subject with Atopic Dermatitis (AD) as defined by Hanifin and Rajka criteria and with mild to moderate disease severity (IGA 2 or 3) as assessed by a dermatologically trained investigator (and confirmed by a board certified dermatologist before or at visit 1)
• Two symmetrically located and comparable Entire Treatment Areas (ETAs) of 20 - 50 cm2 each, i.e. on the same body region (left and right part) and of the same size (complete AD lesion or part of an AD lesion); Total Sign Score (TSS) of at least 5 on both ETAs; difference in TSS not greater than 2 between the two ETAs; sign score for erythema ≥ 2 on both ETAs; difference in Investigator´s Treatment Area assessment of disease severity not greater than 1 between the 2 ETAs

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LEO 32731 cream	LEO 32731 cream	Topical application
LEO 32731 cream vehicle	LEO 32731 cream vehicle	Topical application

Primary Outcome Measures

Name	Time	Method
Total sign score at end of treatment on entire treatment area	3 weeks	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 area

Secondary Outcome Measures

Name	Time	Method
Total sign score on limited treatment area on entire treatment area during trial	3 week
Investigator's treatment area assessment of disease severity on entire treatment area during trial	3 weeks
Subject's treatment area assessment of disease severity on entire treatment area during trial	3 weeks
Subject's assessment of itching on entire treatment area during trial	3 weeks
Transepidermal water loss during trial	3 weeks
Individual signs score on entire treatment during trial	3 weeks

Trial Locations

Locations (1)

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