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Completed

NCT Number: NCT02219633

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

proinnovera GmbH, Center of Dermatology Excellence

Münster, 48159, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LEO 39652 cream

Drug

Applied for 21 days

Primary outcomes

  1. 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.

Secondary outcomes

  1. Total sign score on limited treatment area

    Time frame: 22 days

  2. Investigator's treatment area assessment of disease severity

    Time frame: 22 days

  3. Subject´s treatment area assessment of disease severity

    Time frame: 22 days

  4. Subject´s assessment of itching

    Time frame: 22 days

  5. Transepidermal Water Loss

    Time frame: 22 days

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Aug 19, 2014
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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