A Clinical Trial to Assess the Potential of LEO 130852A Gel to Reduce Steroid Induced Skin Atrophy on Healthy Skin
Phase 1
Completed
- Conditions
- Skin Tissue DiseasesConnective Tissue Diseases
- Interventions
- Registration Number
- NCT02392130
- Lead Sponsor
- LEO Pharma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Drug LEO 130852A gel 1% LEO 130852A gel 1% Placebo Drug LEO 130852A placebo gel LEO 130852A placebo gel Active Drug Clobetasol propionate 0.05% ointment Clobetasol propionate 0.05% ointment
- Primary Outcome Measures
Name Time Method Skin thickness measured by sonography and histology 4 weeks
- Secondary Outcome Measures
Name Time Method Clinical assessments measured by atrophy score 4 weeks Clinical assessments measured by telangiectasia score 4 weeks
Trial Locations
- Locations (1)
bioskin GmbH
🇩🇪Hamburg, Germany