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

Atopic Dermatitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02103725
• Other study ID #: EXP-1092
• Status: Completed
• Phase: Phase 1
• First received: March 26, 2014
• Last updated: September 18, 2015
• Start date: April 2014
• Est. completion date: September 2014

Study information

• Verified date: December 2013
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• pimecrolimus 10 mg/g cream

• Vehicle cream

Locations

Country	Name	City	State
Germany	bioskin GmbH	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the treatment effect defined as total sign score on the treated area at end of the 3 weeks treatment period		3 weeks	No
Secondary	Incidence of adverse events during the 3 weeks treatment period		3 weeks	Yes

External Links

•   Clinical Trials at LEO Pharma