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

February 21, 2025 updated by: LEO Pharma

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

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.

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
      • Münster, Germany, 48159
        • proinnovera GmbH, Center of Dermatology Excellence

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

Description

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 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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LEO 39652 cream
Topical application
Drug: LEO 39652 cream
Applied for 21 days
Placebo Comparator: LEO 39652 cream vehicle
Topical application
Drug: LEO 39652 cream
Applied for 21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total sign score at end of treatment
Time Frame: 22 days
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

Secondary Outcome Measures

Outcome Measure
Time Frame
Total sign score on limited treatment area
Time Frame: 22 days
22 days
Investigator's treatment area assessment of disease severity
Time Frame: 22 days
22 days
Subject´s treatment area assessment of disease severity
Time Frame: 22 days
22 days
Subject´s assessment of itching
Time Frame: 22 days
22 days
Transepidermal Water Loss
Time Frame: 22 days
22 days

Collaborators and Investigators

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

Sponsor

LEO Pharma

Investigators

  • Principal Investigator: Lydia Graßhoff, MD, Proinnovera GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

July 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

August 13, 2014

First Submitted That Met QC Criteria

August 15, 2014

First Posted (Estimated)

August 19, 2014

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LP0083-1085
  • 2014-000849-80 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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