Back to resultsEffect of LEO 39652 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
LEO 39652 cream
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility 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
Sites / Locations
- proinnovera GmbH, Center of Dermatology Excellence
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LEO 39652 cream
LEO 39652 cream vehicle
Arm Description
Topical application
Topical application
Outcomes
Primary Outcome Measures
Total sign score at end of treatment
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
Total sign score on limited treatment area
Investigator's treatment area assessment of disease severity
Subject´s treatment area assessment of disease severity
Subject´s assessment of itching
Transepidermal Water Loss
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02219633
Brief Title
Effect of LEO 39652 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)
Official Title
An Explorative Trial Evaluating the Effect of LEO 39652 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LEO 39652 cream
Arm Type
Experimental
Arm Description
Topical application
Arm Title
LEO 39652 cream vehicle
Arm Type
Placebo Comparator
Arm Description
Topical application
Intervention Type
Drug
Intervention Name(s)
LEO 39652 cream
Intervention Description
Applied for 21 days
Primary Outcome Measure Information:
Title
Total sign score at end of treatment
Description
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.
Time Frame
22 days
Secondary Outcome Measure Information:
Title
Total sign score on limited treatment area
Time Frame
22 days
Title
Investigator's treatment area assessment of disease severity
Time Frame
22 days
Title
Subject´s treatment area assessment of disease severity
Time Frame
22 days
Title
Subject´s assessment of itching
Time Frame
22 days
Title
Transepidermal Water Loss
Time Frame
22 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lydia Graßhoff, MD
Organizational Affiliation
Proinnovera GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
proinnovera GmbH, Center of Dermatology Excellence
City
Münster
ZIP/Postal Code
48159
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Effect of LEO 39652 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)
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