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Completed

NCT Number: NCT02496546

An Explorative Trial Evaluating the Effect of LEO 32731 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)

The aim of this trial is to assess the efficacy of LEO 32731 cream 20 mg/g compared with LEO 32731 cream vehicle in adults with mild to moderate AD after 3 weeks of treatment.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Male

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

  • Following verbal and written information about the trial, subjects must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial related procedures being carried out
  • Subject with Atopic Dermatitis (AD) as defined by Hanifin and Rajka criteria and with mild to moderate disease severity (IGA 2 or 3) as assessed by a dermatologically trained investigator (and confirmed by a board certified dermatologist before or at visit 1)
  • Two symmetrically located and comparable Entire Treatment Areas (ETAs) of 20 - 50 cm2 each, i.e. on the same body region (left and right part) and of the same size (complete AD lesion or part of an AD lesion); Total Sign Score (TSS) of at least 5 on both ETAs; difference in TSS not greater than 2 between the two ETAs; sign score for erythema ≥ 2 on both ETAs; difference in Investigator´s Treatment Area assessment of disease severity not greater than 1 between the 2 ETAs

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

Treatment and study plan

LEO 32731 cream

Drug

Applied for 3 weeks

LEO 32731 cream vehicle

Drug

Applied for 3 weeks

Primary outcomes

  1. Total sign score at end of treatment on entire treatment area

    Time frame: 3 weeks

    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 area

Secondary outcomes

  1. Total sign score on limited treatment area on entire treatment area during trial

    Time frame: 3 week

  2. Investigator's treatment area assessment of disease severity on entire treatment area during trial

    Time frame: 3 weeks

  3. Subject's treatment area assessment of disease severity on entire treatment area during trial

    Time frame: 3 weeks

  4. Subject's assessment of itching on entire treatment area during trial

    Time frame: 3 weeks

  5. Transepidermal water loss during trial

    Time frame: 3 weeks

  6. Individual signs score on entire treatment during trial

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

An Explorative Trial Evaluating the Effect of LEO 32731 Cream 20 mg/g in Adults With Mild to Moderate Atopic Dermatitis (AD)

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 14, 2015
Registry last updated
May 3, 2017

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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