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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02219633
Recruitment Status : Completed
First Posted : August 19, 2014
Last Update Posted : June 14, 2016
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Brief 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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: LEO 39652 cream Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Explorative Trial Evaluating the Effect of LEO 39652 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)
Study Start Date : July 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219633


Locations
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Germany
proinnovera GmbH, Center of Dermatology Excellence
Münster, Germany, 48159
Sponsors and Collaborators
LEO Pharma
Investigators
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Principal Investigator: Lydia Graßhoff, MD Proinnovera GmbH
Additional Information:
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02219633    
Other Study ID Numbers: LP0083-1085
2014-000849-80 ( EudraCT Number )
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases