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OpenTrials
Completed

NCT Number: NCT02392130

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

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.

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Key information

Conditions

Skin Tissue Diseases Connective Tissue Diseases Skin and Connective Tissue Diseases

Age range

25 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

bioskin GmbH

Hamburg, 20095, 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 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

Treatment and study plan

clobetasol propionate 0.05% ointment

Drug

LEO 130852A gel 1%

Drug

LEO 130852A placebo gel

Drug

Primary outcomes

  1. Skin thickness measured by sonography and histology

    Time frame: 4 weeks

Secondary outcomes

  1. Clinical assessments measured by atrophy score

    Time frame: 4 weeks

  2. Clinical assessments measured by telangiectasia score

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 18, 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.

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