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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02103725

Enrollment

Registered

2014-04-04

Start date

2014-04-30

Completion date

2014-09-30

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Brief summary

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

Interventions

DRUGpimecrolimus 10 mg/g cream

DRUGVehicle cream

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Evaluation of the treatment effect defined as total sign score on the treated area at end of the 3 weeks treatment period	3 weeks

Secondary

Measure	Time frame
Incidence of adverse events during the 3 weeks treatment period	3 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026