Back to resultsSafety and Efficacy Study in Subjects With Seborrheic Dermatitis
Primary Purpose
Seborrheic Dermatitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Test Product 49778
Test Product 10156
Vehicle (placebo)
Sponsored by
About this trial
This is an interventional treatment trial for Seborrheic Dermatitis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Vehicle
Test Product 10156
Test Product 49778
Arm Description
Vehicle (placebo) treatment, twice a week for four weeks.
Product 10156 treatment, twice a week for four weeks.
Product 49778 treatment, twice a week for four weeks.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Symptom Improvement (subject assessment)
Assess the change in the pruritus score from baseline to week 2 and to week 4.
Full Information
NCT ID
NCT01703793
First Posted
October 7, 2012
Last Updated
January 7, 2013
Sponsor
Medicis Global Service Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01703793
Brief Title
Safety and Efficacy Study in Subjects With Seborrheic Dermatitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medicis Global Service Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if two test products are safe and effective in the treatment of seborrheic dermatitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seborrheic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle (placebo) treatment, twice a week for four weeks.
Arm Title
Test Product 10156
Arm Type
Experimental
Arm Description
Product 10156 treatment, twice a week for four weeks.
Arm Title
Test Product 49778
Arm Type
Experimental
Arm Description
Product 49778 treatment, twice a week for four weeks.
Intervention Type
Drug
Intervention Name(s)
Test Product 49778
Intervention Type
Drug
Intervention Name(s)
Test Product 10156
Intervention Type
Drug
Intervention Name(s)
Vehicle (placebo)
Primary Outcome Measure Information:
Title
Symptom Improvement (investigator assessment)
Description
Proportion of subjects with a response of clear or almost clear, and at least a two-grade improvement from baseline to week 4
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Symptom Improvement (subject assessment)
Description
Assess the change in the pruritus score from baseline to week 2 and to week 4.
Time Frame
Weeks 2 and 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ira Lawrence, MD
Organizational Affiliation
Medicis Pharmaceutical
Official's Role
Study Chair
Facility Information:
City
Fremont
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
New Haven
State/Province
Connecticut
Country
United States
City
Aventura
State/Province
Florida
Country
United States
City
Augusta
State/Province
Georgia
Country
United States
City
Snellville
State/Province
Georgia
Country
United States
City
Evansville
State/Province
Indiana
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Fridley
State/Province
Minnesota
Country
United States
City
Paramus
State/Province
New Jersey
Country
United States
City
Mount Kisco
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
High Point
State/Province
North Carolina
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Arlington
State/Province
Texas
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
College Station
State/Province
Texas
Country
United States
City
Plano
State/Province
Texas
Country
United States
City
Webster
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
12. IPD Sharing Statement
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Safety and Efficacy Study in Subjects With Seborrheic Dermatitis
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