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

NCT ID: NCT02103725

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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pimecrolimus 10 mg/g cream

Active drug

Group Type EXPERIMENTAL

pimecrolimus 10 mg/g cream

Intervention Type DRUG

Vehicle cream

Placebo drug

Group Type PLACEBO_COMPARATOR

Vehicle cream

Intervention Type DRUG

Interventions

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pimecrolimus 10 mg/g cream

Intervention Type DRUG

Vehicle cream

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LEO Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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bioskin GmbH

Hamburg, , Germany

Site Status

Countries

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Germany

Related Links

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https://www.leopharmatrials.com/en

Clinical Trials at LEO Pharma

Other Identifiers

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EXP-1092

Identifier Type: -

Identifier Source: org_study_id

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