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

NCT ID: NCT02355639

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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-04-30

Brief Summary

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

Detailed Description

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Conditions

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Skin and 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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Clobetasol propionate 0.05 % ointment

Active drug

Group Type EXPERIMENTAL

Clobetasol propionate 0.05 % ointment

Intervention Type DRUG

Betamethasone dipropionate 0.064 % ointment

Active drug

Group Type EXPERIMENTAL

Betamethasone dipropionate 0.064 % ointment

Intervention Type DRUG

Petrolatum ointment

Placebo drug

Group Type PLACEBO_COMPARATOR

Petrolatum ointment

Intervention Type DRUG

Interventions

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Clobetasol propionate 0.05 % ointment

Intervention Type DRUG

Betamethasone dipropionate 0.064 % ointment

Intervention Type DRUG

Petrolatum ointment

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

40 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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Charité - Universitaetsmedizin Berlin, Department of Dermatology and Allergy

Berlin, , 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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EXP-1090

Identifier Type: -

Identifier Source: org_study_id

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