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

LEO Pharma

Status and phase

Completed

Phase 1

Conditions

Atopic Dermatitis

Treatments

Drug: LEO 32731 cream vehicle

Drug: LEO 32731 cream

Study type

Interventional

Funder types

Industry

Identifiers

NCT02496546

LP0108-1082

2014-000519-15 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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