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

LEO Pharma

Status and phase: Completed; Phase 1

Conditions: Skin and Connective Tissue Diseases

Treatments: Drug: Betamethasone dipropionate 0.064 % ointment; Drug: Clobetasol propionate 0.05 % ointment; Drug: Petrolatum ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT02355639

EXP-1090

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: Male

Ages: 25 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 3 patient groups, including a placebo group

Clobetasol propionate 0.05 % ointment

Experimental group

Description:

Active drug

Treatment:

Drug: Clobetasol propionate 0.05 % ointment

Betamethasone dipropionate 0.064 % ointment

Experimental group

Description:

Active drug

Treatment:

Drug: Betamethasone dipropionate 0.064 % ointment

Petrolatum ointment

Placebo Comparator group

Description:

Placebo drug

Treatment:

Drug: Petrolatum ointment