Skip to main content
OpenTrials
Completed

NCT Number: NCT02355639

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Skin and Connective Tissue Diseases

Age range

25 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Charité - Universitaetsmedizin Berlin, Department of Dermatology and Allergy

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male volunteers, 25 to 40 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.

Treatment and study plan

Clobetasol propionate 0.05 % ointment

Drug

Betamethasone dipropionate 0.064 % ointment

Drug

Petrolatum ointment

Drug

Primary outcomes

  1. Change in skin thickness from baseline to end of treatment

    Time frame: 4 weeks

Secondary outcomes

  1. Relation of clinical features (skin transparency and telangiectasia) to the steroid induced skin atrophy after end of treatment

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 4, 2015
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.