Effect of LEO 39652 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)

Atopic Dermatitis Clinical Trial

Official title:

An Explorative Trial Evaluating the Effect of LEO 39652 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02219633
• Other study ID #: LP0083-1085
• Secondary ID: 2014-000849-80
• Status: Completed
• Phase: Phase 1
• First received: August 13, 2014
• Last updated: June 13, 2016
• Start date: July 2014
• Est. completion date: January 2015

Study information

• Verified date: June 2016
• 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 aim of this trial is to assess the efficacy of LEO 39652 cream compared with LEO 39652 cream vehicle in adults with mild to moderate AD after 3 weeks of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects with Atopic Dermatitis (AD) as defined by Hanifin and Rajka criteria and with mild to moderate disease severity (IGA 2 or 3)

• Two symmetrical and comparable Entire Treatment Areas, on the same body region (left and right part)

• Subjects must be in good health

• Female subjects of childbearing potential and male subjects must be willing to consent to using high effective methods of contraception

Exclusion Criteria:

• Any condition in the treatment 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 (i.e. skin type IV to VI according to Fitzpatrick classification system) whose skin colour prevents reliable clinical assessments

• Any permanent (or transient within 28 days prior to dosing) disease (in particular cardiac disease such as heart failure or history of myocardial infarction) 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

• Subjects with congenital or acquired immunodeficiencies or in subjects on therapy that causes immunosuppression

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• LEO 39652 cream
Applied for 21 days

Locations

Country	Name	City	State
Germany	proinnovera GmbH, Center of Dermatology Excellence	Münster

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total sign score at end of treatment	Total Sign Score is defined as the sum of severity scores (4-point scale) of the Individual Sign Scores(erythema, edema/papulation, oozing/crusting, excoriations, lichenification and dryness)for each assessed area.	22 days	No
Secondary	Total sign score on limited treatment area		22 days	No
Secondary	Investigator's treatment area assessment of disease severity		22 days	No
Secondary	Subject´s treatment area assessment of disease severity		22 days	No
Secondary	Subject´s assessment of itching		22 days	No
Secondary	Transepidermal Water Loss		22 days	No

External Links

•   Clinical Trials at LEO Pharma