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

February 21, 2025 updated by: LEO Pharma

A Single-Centre, Explorative, Randomised, Investigator-Blinded, Negative-Controlled, Phase I Clinical Trial With Intra-Individual Comparison of Treatments to Assess Steroid Induced Skin Atrophy on Healthy Skin

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité - Universitaetsmedizin Berlin, Department of Dermatology and Allergy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clobetasol propionate 0.05 % ointment
Active drug
Drug: Clobetasol propionate 0.05 % ointment
Experimental: Betamethasone dipropionate 0.064 % ointment
Active drug
Drug: Betamethasone dipropionate 0.064 % ointment
Placebo Comparator: Petrolatum ointment
Placebo drug
Drug: Petrolatum ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in skin thickness from baseline to end of treatment
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Relation of clinical features (skin transparency and telangiectasia) to the steroid induced skin atrophy after end of treatment
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

January 27, 2015

First Submitted That Met QC Criteria

January 30, 2015

First Posted (Estimated)

February 4, 2015

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXP-1090

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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