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Completed

NCT Number: NCT02103725

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

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

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

bioskin GmbH

Hamburg, 20095, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Male and female subjects, 18 years or older
  • 2. Subject with atopic dermatitis with mild to moderate disease severity
  • 3. Two symmetrical and comparable atopic dermatitis treatment areas
  • 4. 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
  • 2. Dark-skinned persons whose skin colour prevents reliable clinical assessments
  • 3. 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
  • 4. Pregnancy or breastfeeding

Treatment and study plan

pimecrolimus 10 mg/g cream

Drug

Vehicle cream

Drug

Primary outcomes

  1. Evaluation of the treatment effect defined as total sign score on the treated area at end of the 3 weeks treatment period

    Time frame: 3 weeks

Secondary outcomes

  1. Incidence of adverse events during the 3 weeks treatment period

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

A Phase I, Multi-Centre, Randomised, Vehicle-Controlled, Double-Blinded, Explorative Clinical Trial to Evaluate a Left-Right Design in Adults With Mild to Moderate Atopic Dermatitis Over a Treatment Period of Three Weeks

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 4, 2014
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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