Back to resultsA Single-Centre Clinical Trial to Assess Steroid Induced Skin Atrophy on Healthy Skin
Primary Purpose
Skin and Connective Tissue Diseases
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Clobetasol propionate 0.05 % ointment
Betamethasone dipropionate 0.064 % ointment
Petrolatum ointment
Sponsored by
About this trial
This is an interventional other trial for Skin and Connective Tissue Diseases
Eligibility Criteria
Inclusion Criteria:
- Healthy male volunteers, 25 to 40 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
- Charité - Universitaetsmedizin Berlin, Department of Dermatology and Allergy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Clobetasol propionate 0.05 % ointment
Betamethasone dipropionate 0.064 % ointment
Petrolatum ointment
Arm Description
Active drug
Active drug
Placebo drug
Outcomes
Primary Outcome Measures
Change in skin thickness from baseline to end of treatment
Secondary Outcome Measures
Relation of clinical features (skin transparency and telangiectasia) to the steroid induced skin atrophy after end of treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02355639
Brief Title
A Single-Centre Clinical Trial to Assess Steroid Induced Skin Atrophy on Healthy Skin
Official Title
A Single-Centre, Explorative, Randomised, Investigator-Blinded, Negative-Controlled, Phase I Clinical Trial With Intra-Individual Comparison of Treatments to Assess 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
January 2015 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 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 steroid induced skin atrophy by sonography.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin and Connective Tissue Diseases
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clobetasol propionate 0.05 % ointment
Arm Type
Experimental
Arm Description
Active drug
Arm Title
Betamethasone dipropionate 0.064 % ointment
Arm Type
Experimental
Arm Description
Active drug
Arm Title
Petrolatum ointment
Arm Type
Placebo Comparator
Arm Description
Placebo drug
Intervention Type
Drug
Intervention Name(s)
Clobetasol propionate 0.05 % ointment
Intervention Type
Drug
Intervention Name(s)
Betamethasone dipropionate 0.064 % ointment
Intervention Type
Drug
Intervention Name(s)
Petrolatum ointment
Primary Outcome Measure Information:
Title
Change in skin thickness from baseline to end of treatment
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Relation of clinical features (skin transparency and telangiectasia) to the steroid induced skin atrophy after end of treatment
Time Frame
4 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male volunteers, 25 to 40 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
Charité - Universitaetsmedizin Berlin, Department of Dermatology and Allergy
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Single-Centre Clinical Trial to Assess Steroid Induced Skin Atrophy on Healthy Skin
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