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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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