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NCT02355639 Clinical Trial

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

Skin and Connective Tissue Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02355639
Other study ID # EXP-1090
Secondary ID
Status Completed
Phase Phase 1
First received January 27, 2015
Last updated May 1, 2017
Start date January 2015
Est. completion date April 2015

Study information
Verified date May 2017
Source LEO Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 25 Years to 40 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Clobetasol propionate 0.05 % ointment

• Betamethasone dipropionate 0.064 % ointment

• Petrolatum ointment

Locations
Country Name City State
Germany Charité - Universitaetsmedizin Berlin, Department of Dermatology and Allergy Berlin

Sponsors (1)
Lead Sponsor Collaborator
LEO Pharma

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in skin thickness from baseline to end of treatment 4 weeks
Secondary Relation of clinical features (skin transparency and telangiectasia) to the steroid induced skin atrophy after end of treatment 4 weeks
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