Safety and Efficacy Study in Subjects With Seborrheic Dermatitis

Phase 2

Completed

• Conditions: Seborrheic Dermatitis
• Interventions: Drug: Vehicle (placebo); Drug: Test Product 10156; Drug: Test Product 49778

• Registration Number: NCT01703793
• Lead Sponsor: Medicis Global Service Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-10-07
• Study First Submitted QC: 2012-10-07
• Study First Posted: 2012-10-11
• Status Verified: 2013-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2013-01-07
• Last Update Posted: 2013-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle (placebo)	Vehicle (placebo) treatment, twice a week for four weeks.
Test Product 10156	Test Product 10156	Product 10156 treatment, twice a week for four weeks.
Test Product 49778	Test Product 49778	Product 49778 treatment, twice a week for four weeks.

Primary Outcome Measures

Name	Time	Method
Symptom Improvement (investigator assessment)	Week 4	Proportion of subjects with a response of clear or almost clear, and at least a two-grade improvement from baseline to week 4

Secondary Outcome Measures

Name	Time	Method
Symptom Improvement (subject assessment)	Weeks 2 and 4	Assess the change in the pruritus score from baseline to week 2 and to week 4.