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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02392130
Enrollment
40
Registered
2015-03-18
Start date
2015-03-31
Completion date
2015-06-30
Last updated
2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Connective Tissue Diseases, Skin Tissue Diseases

Brief summary

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.

Interventions

DRUGLEO 130852A gel 1%
DRUGLEO 130852A placebo gel

Sponsors

LEO Pharma
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
MALE
Age
25 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Skin thickness measured by sonography and histology4 weeks

Secondary

MeasureTime frame
Clinical assessments measured by atrophy score4 weeks
Clinical assessments measured by telangiectasia score4 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026