A Single-Centre Clinical Trial to Assess Steroid Induced Skin Atrophy on Healthy Skin

Phase 1

Completed

• Conditions: Skin and Connective Tissue Diseases
• Interventions: Drug: Clobetasol propionate 0.05 % ointment; Drug: Betamethasone dipropionate 0.064 % ointment; Drug: Petrolatum ointment

• Registration Number: NCT02355639
• Lead Sponsor: LEO Pharma

Brief Summary

The purpose of this study is to assess steroid induced skin atrophy by sonography.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-27
• Study First Submitted QC: 2015-01-30
• Study First Posted: 2015-02-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2017-05
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

1. Healthy male volunteers, 25 to 40 years old inclusive.
2. Healthy skin on volar arms with a hairless area sufficient for measurements

Exclusion Criteria

1. Clinical skin atrophy, telangiectasia or striae on volar arms.
2. Presence of any skin condition or colouration that would interfere with test sites or the response or assessment.
3. Fitzpatrick skin type IV - VI.
4. 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
Clobetasol propionate 0.05 % ointment	Clobetasol propionate 0.05 % ointment	Active drug
Betamethasone dipropionate 0.064 % ointment	Betamethasone dipropionate 0.064 % ointment	Active drug
Petrolatum ointment	Petrolatum ointment	Placebo drug

Primary Outcome Measures

Name	Time	Method
Change in skin thickness from baseline to end of treatment	4 weeks

Secondary Outcome Measures

Name	Time	Method
Relation of clinical features (skin transparency and telangiectasia) to the steroid induced skin atrophy after end of treatment	4 weeks

Trial Locations

Locations (1)

Charité - Universitaetsmedizin Berlin, Department of Dermatology and Allergy; 🇩🇪 Berlin, Germany