Safety and Efficacy Study in Subjects With Seborrheic Dermatitis

Medicis Global Service

Status and phase: Completed; Phase 2

Conditions: Seborrheic Dermatitis

Treatments: Drug: Vehicle (placebo); Drug: Test Product 10156; Drug: Test Product 49778

Study type: Interventional

Funder types: Industry

Identifiers

NCT01703793

MP-1001-01

Details and patient eligibility

About

The purpose of this study is to determine if two test products are safe and effective in the treatment of seborrheic dermatitis.

Enrollment: 240 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Investigator assessment of seborrheic dermatitis.
• Additional criteria as identified in the protocol.

Exclusion criteria

• History of or ongoing psoriasis of the scalp.
• History of or ongoing atopic dermatitis of the scalp.
• Additional criteria as identified in the protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 3 patient groups, including a placebo group

Vehicle

Placebo Comparator group

Description:

Vehicle (placebo) treatment, twice a week for four weeks.

Treatment:

Drug: Vehicle (placebo)

Test Product 10156

Experimental group

Description:

Product 10156 treatment, twice a week for four weeks.

Treatment:

Drug: Test Product 10156

Test Product 49778

Experimental group

Description:

Product 49778 treatment, twice a week for four weeks.

Treatment:

Drug: Test Product 49778