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

LEO Pharma

Status and phase: Completed; Phase 1

Conditions: Connective Tissue Diseases; Skin Tissue Diseases

Treatments: Drug: LEO 130852A gel 1%; Drug: LEO 130852A placebo gel; Drug: Clobetasol propionate 0.05% ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT02392130

SKAT-1129

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Male

Ages: 25 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 3 patient groups, including a placebo group

Active Drug

Active Comparator group

Description:

Clobetasol propionate 0.05% ointment

Treatment:

Drug: Clobetasol propionate 0.05% ointment

Experimental Drug

Experimental group

Description:

LEO 130852A gel 1%

Treatment:

Drug: LEO 130852A gel 1%

Placebo Drug

Placebo Comparator group

Description:

LEO 130852A placebo gel

Treatment:

Drug: LEO 130852A placebo gel