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

NCT ID: NCT02392130

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Skin Tissue Diseases Connective Tissue Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Active Drug

Clobetasol propionate 0.05% ointment

Group Type ACTIVE_COMPARATOR

Clobetasol propionate 0.05% ointment

Intervention Type DRUG

Experimental Drug

LEO 130852A gel 1%

Group Type EXPERIMENTAL

LEO 130852A gel 1%

Intervention Type DRUG

Placebo Drug

LEO 130852A placebo gel

Group Type PLACEBO_COMPARATOR

LEO 130852A placebo gel

Intervention Type DRUG

Interventions

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Clobetasol propionate 0.05% ointment

Intervention Type DRUG

LEO 130852A gel 1%

Intervention Type DRUG

LEO 130852A placebo gel

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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LEO Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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bioskin GmbH

Hamburg, , Germany

Site Status

Countries

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Germany

Related Links

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https://www.leopharmatrials.com/en

Clinical Trials at LEO Pharma

Other Identifiers

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SKAT-1129

Identifier Type: -

Identifier Source: org_study_id

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