A Multi-Centre Clinical Trial to Evaluate a Left-Right Design in Adults With Mild to Moderate Atopic Dermatitis

LEO Pharma

Status and phase

Completed

Phase 1

Conditions

Atopic Dermatitis

Treatments

Drug: pimecrolimus 10 mg/g cream

Drug: Vehicle cream

Study type

Interventional

Funder types

Industry

Identifiers

NCT02103725

EXP-1092

Details and patient eligibility

About

The purpose of this study is to validate a left-right design with respect to detecting a difference in efficacy after 3 weeks of treatment between an active treatment and a vehicle in adults with mild to moderate atopic dermatitis

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Male and female subjects, 18 years or older
1. Subject with atopic dermatitis with mild to moderate disease severity
1. Two symmetrical and comparable atopic dermatitis treatment areas
1. Female volunteers of childbearing potential must either be surgically sterile or agree to use a reliable method of contraception

Exclusion criteria

1. Any condition in the target 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
1. Dark-skinned persons whose skin colour prevents reliable clinical assessments
1. Any permanent (or transient within 28 days prior to dosing) disease 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
1. Pregnancy or breastfeeding