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

September 18, 2015 updated by: LEO Pharma

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20095
        • Bioskin GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pimecrolimus 10 mg/g cream
Active drug
Drug: pimecrolimus 10 mg/g cream
Placebo Comparator: Vehicle cream
Placebo drug
Drug: Vehicle cream

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events during the 3 weeks treatment period
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

March 26, 2014

First Submitted That Met QC Criteria

April 1, 2014

First Posted (Estimate)

April 4, 2014

Study Record Updates

Last Update Posted (Estimate)

September 22, 2015

Last Update Submitted That Met QC Criteria

September 18, 2015

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXP-1092

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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