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
1 other identifier
interventional
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2014
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedFirst Posted
Study publicly available on registry
April 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedFebruary 24, 2025
December 1, 2013
5 months
March 26, 2014
February 21, 2025
Conditions
Outcome Measures
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
3 weeks
Secondary Outcomes (1)
Incidence of adverse events during the 3 weeks treatment period
3 weeks
Study Arms (2)
pimecrolimus 10 mg/g cream
EXPERIMENTALActive drug
Vehicle cream
PLACEBO COMPARATORPlacebo drug
Interventions
Eligibility Criteria
You may qualify if:
- \. Male and female subjects, 18 years or older
- \. Subject with atopic dermatitis with mild to moderate disease severity
- \. Two symmetrical and comparable atopic dermatitis treatment areas
- \. Female volunteers of childbearing potential must either be surgically sterile or agree to use a reliable method of contraception
You may not qualify if:
- \. 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
- \. Dark-skinned persons whose skin colour prevents reliable clinical assessments
- \. 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
- \. Pregnancy or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LEO Pharmalead
Study Sites (1)
bioskin GmbH
Hamburg, 20095, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2014
First Posted
April 4, 2014
Study Start
April 1, 2014
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
February 24, 2025
Record last verified: 2013-12
Data Sharing
- IPD Sharing
- Will not share