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

NCT ID: NCT02219633

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LEO 39652 cream

Topical application

Group Type EXPERIMENTAL

LEO 39652 cream

Intervention Type DRUG

Applied for 21 days

LEO 39652 cream vehicle

Topical application

Group Type PLACEBO_COMPARATOR

LEO 39652 cream

Intervention Type DRUG

Applied for 21 days

Interventions

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LEO 39652 cream

Applied for 21 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LEO Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lydia Graßhoff, MD

Role: PRINCIPAL_INVESTIGATOR

Proinnovera GmbH

Locations

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proinnovera GmbH, Center of Dermatology Excellence

Münster, , Germany

Site Status

Countries

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Germany

Related Links

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https://www.leopharmatrials.com/en

Clinical Trials at LEO Pharma

Other Identifiers

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2014-000849-80

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LP0083-1085

Identifier Type: -

Identifier Source: org_study_id

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