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NCT02392130 Clinical Trial

A Clinical Trial to Assess the Potential of LEO 130852A Gel to Reduce Steroid Induced Skin Atrophy on Healthy Skin

Connective Tissue Diseases Clinical Trial

Official title:
A Prospective, Randomised, Investigator-Blinded, Vehicle-Controlled, Phase I Clinical Trial With Intra-Individual Comparison of Treatments to Assess the Potential of LEO 130852A Gel to Reduce Steroid Induced Skin Atrophy on Healthy Skin

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02392130
Other study ID # SKAT-1129
Secondary ID
Status Completed
Phase Phase 1
First received March 6, 2015
Last updated May 1, 2017
Start date March 2015
Est. completion date June 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 the effect of LEO 130852A gel 1% in maintaining skin thickness in healthy skin treated with steroid.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 25 Years to 50 Years
Eligibility Inclusion Criteria:

- Healthy male volunteers, 25 to 50 years old inclusive

- Healthy skin on volar arms with a hairless area sufficient for measurements

Exclusion Criteria:

- Clinical skin atrophy, telangiectasia or striae on volar arms

- Presence of any skin condition or colouration that would interfere with test sites or the response or assessment

- Fitzpatrick skin type IV - VI

- 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

• LEO 130852A gel 1%

• LEO 130852A placebo gel

Locations
Country Name City State
Germany bioskin GmbH Hamburg

Sponsors (1)
Lead Sponsor Collaborator
LEO Pharma

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Skin thickness measured by sonography and histology 4 weeks
Secondary Clinical assessments measured by atrophy score 4 weeks
Secondary Clinical assessments measured by telangiectasia score 4 weeks
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