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A Clinical Trial to Assess the Potential of LEO 130852A Gel to Reduce 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 Tissue Diseases; Connective Tissue Diseases

Intervention: Clobetasol propionate 0.05% ointment (Drug); LEO 130852A gel 1% (Drug); LEO 130852A placebo gel (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: LEO Pharma

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.

Clinical Details

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

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

Primary outcome: Skin thickness measured by sonography and histology

Secondary outcome:

Clinical assessments measured by atrophy score

Clinical assessments measured by telangiectasia score

Eligibility

Minimum age: 25 Years. Maximum age: 50 Years. Gender(s): Male.

Criteria:

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

Locations and Contacts

bioskin GmbH, Hamburg 20095, Germany
Additional Information

Starting date: March 2015
Last updated: August 12, 2015

Page last updated: August 23, 2015

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