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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02355639

Enrollment

Registered

2015-02-04

Start date

2015-01-31

Completion date

2015-04-30

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

Skin and Connective Tissue Diseases

Brief summary

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

Interventions

DRUGClobetasol propionate 0.05 % ointment

DRUGBetamethasone dipropionate 0.064 % ointment

DRUGPetrolatum ointment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

MALE

Age

25 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Change in skin thickness from baseline to end of treatment	4 weeks

Secondary

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

Countries

Germany

Outcome results

None listed

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