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

Skin and Connective Tissue Diseases Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02355639
• Other study ID #: EXP-1090
• Status: Completed
• Phase: Phase 1
• First received: January 27, 2015
• Last updated: May 1, 2017
• Start date: January 2015
• Est. completion date: April 2015

Study information

• Verified date: May 2017
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Connective Tissue Diseases
• Skin and Connective Tissue Diseases

Intervention

Drug:
• Clobetasol propionate 0.05 % ointment

• Betamethasone dipropionate 0.064 % ointment

• Petrolatum ointment

Locations

Country	Name	City	State
Germany	Charité - Universitaetsmedizin Berlin, Department of Dermatology and Allergy	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in skin thickness from baseline to end of treatment		4 weeks
Secondary	Relation of clinical features (skin transparency and telangiectasia) to the steroid induced skin atrophy after end of treatment		4 weeks

External Links

•   Clinical Trials at LEO Pharma