Seborrheic Dermatitis Clinical Trial
Official title:
A Parallel-group, Vehicle-controlled, Randomized, Double-blind Study of the Efficacy and Safety of Product 49778 and Product 10156 in Subjects With Seborrheic Dermatitis
The purpose of this study is to determine if two test products are safe and effective in the treatment of seborrheic dermatitis.
Status | Completed |
Enrollment | 240 |
Est. completion date | January 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Medicis Global Service Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Symptom Improvement (investigator assessment) | Proportion of subjects with a response of clear or almost clear, and at least a two-grade improvement from baseline to week 4 | Week 4 | No |
Secondary | Symptom Improvement (subject assessment) | Assess the change in the pruritus score from baseline to week 2 and to week 4. | Weeks 2 and 4 | No |
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