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

Phase 1CompletedNCT02355639

LEO Pharma16 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Skin and Connective Tissue Diseases

Interventions

Clobetasol propionate 0.05 % ointmentDRUG

Betamethasone dipropionate 0.064 % ointmentDRUG

Petrolatum ointmentDRUG

Eligibility

Sex: MALEMin age: 25 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Charité - Universitaetsmedizin Berlin, Department of Dermatology and Allergy

Berlin, Germany

Outcomes

Primary Outcomes

Change in skin thickness from baseline to end of treatment

Time frame: 4 weeks

Secondary Outcomes

Relation of clinical features (skin transparency and telangiectasia) to the steroid induced skin atrophy after end of treatment

Time frame: 4 weeks

Data from ClinicalTrials.gov

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