Back to resultsA Clinical Trial to Assess the Potential of LEO 130852A Gel to Reduce Steroid Induced Skin Atrophy on Healthy Skin
Primary Purpose
Skin Tissue Diseases, Connective Tissue Diseases
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Clobetasol propionate 0.05% ointment
LEO 130852A gel 1%
LEO 130852A placebo gel
Sponsored by
About this trial
This is an interventional other trial for Skin Tissue Diseases
Eligibility Criteria
Inclusion Criteria:
- Healthy male volunteers, 25 to 50 years old inclusive
- Healthy skin on volar arms with a hairless area sufficient for measurements
Exclusion Criteria:
- Clinical skin atrophy, telangiectasia or striae on volar arms
- Presence of any skin condition or colouration that would interfere with test sites or the response or assessment
- Fitzpatrick skin type IV - VI
- History or current evidence of infection, eczema or other relevant skin disease
Sites / Locations
- bioskin GmbH
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Placebo Comparator
Arm Label
Active Drug
Experimental Drug
Placebo Drug
Arm Description
Clobetasol propionate 0.05% ointment
LEO 130852A gel 1%
LEO 130852A placebo gel
Outcomes
Primary Outcome Measures
Skin thickness measured by sonography and histology
Secondary Outcome Measures
Clinical assessments measured by atrophy score
Clinical assessments measured by telangiectasia score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02392130
Brief Title
A Clinical Trial to Assess the Potential of LEO 130852A Gel to Reduce Steroid Induced Skin Atrophy on Healthy Skin
Official Title
A Prospective, Randomised, Investigator-Blinded, Vehicle-Controlled, Phase I Clinical Trial With Intra-Individual Comparison of Treatments to Assess the Potential of LEO 130852A Gel to Reduce Steroid Induced Skin Atrophy on Healthy Skin
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 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 purpose of this study is to assess the effect of LEO 130852A gel 1% in maintaining skin thickness in healthy skin treated with steroid.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Tissue Diseases, Connective Tissue Diseases
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Drug
Arm Type
Active Comparator
Arm Description
Clobetasol propionate 0.05% ointment
Arm Title
Experimental Drug
Arm Type
Experimental
Arm Description
LEO 130852A gel 1%
Arm Title
Placebo Drug
Arm Type
Placebo Comparator
Arm Description
LEO 130852A placebo gel
Intervention Type
Drug
Intervention Name(s)
Clobetasol propionate 0.05% ointment
Intervention Type
Drug
Intervention Name(s)
LEO 130852A gel 1%
Intervention Type
Drug
Intervention Name(s)
LEO 130852A placebo gel
Primary Outcome Measure Information:
Title
Skin thickness measured by sonography and histology
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Clinical assessments measured by atrophy score
Time Frame
4 weeks
Title
Clinical assessments measured by telangiectasia score
Time Frame
4 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male volunteers, 25 to 50 years old inclusive
Healthy skin on volar arms with a hairless area sufficient for measurements
Exclusion Criteria:
Clinical skin atrophy, telangiectasia or striae on volar arms
Presence of any skin condition or colouration that would interfere with test sites or the response or assessment
Fitzpatrick skin type IV - VI
History or current evidence of infection, eczema or other relevant skin disease
Facility Information:
Facility Name
bioskin GmbH
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial to Assess the Potential of LEO 130852A Gel to Reduce Steroid Induced Skin Atrophy on Healthy Skin
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