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

Information source: LEO Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Skin and Connective Tissue Diseases

Intervention: Clobetasol propionate 0.05 % ointment (Drug); Betamethasone dipropionate 0.064 % ointment (Drug); Petrolatum ointment (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: LEO Pharma

Overall contact:
Rikke L Fischer, Phone: +4544945888, Email: rikke.fischer@leo-pharma.com


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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Primary outcome: Change in skin thickness from baseline to end of treatment

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


Minimum age: 25 Years. Maximum age: 40 Years. Gender(s): Male.


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 and Contacts

Rikke L Fischer, Phone: +4544945888, Email: rikke.fischer@leo-pharma.com

Charité - Universitaetsmedizin Berlin, Department of Dermatology and Allergy, Berlin 10117, Germany; Recruiting
Phone: +4930450518122, Email: crc-office@charite.de
Additional Information

Starting date: January 2015
Last updated: February 18, 2015

Page last updated: August 23, 2015

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