Safety and Efficacy Study in Subjects With Seborrheic Dermatitis
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
1 other identifier
interventional
240
1 country
22
Brief Summary
The purpose of this study is to determine if two test products are safe and effective in the treatment of seborrheic dermatitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2012
Shorter than P25 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 7, 2012
CompletedFirst Posted
Study publicly available on registry
October 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedJanuary 9, 2013
January 1, 2013
4 months
October 7, 2012
January 7, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Symptom Improvement (subject assessment)
Weeks 2 and 4
Study Arms (3)
Vehicle
PLACEBO COMPARATORVehicle (placebo) treatment, twice a week for four weeks.
Test Product 10156
EXPERIMENTALProduct 10156 treatment, twice a week for four weeks.
Test Product 49778
EXPERIMENTALProduct 49778 treatment, twice a week for four weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Investigator assessment of seborrheic dermatitis.
- Additional criteria as identified in the protocol.
You may not qualify if:
- History of or ongoing psoriasis of the scalp.
- History of or ongoing atopic dermatitis of the scalp.
- Additional criteria as identified in the protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Unknown Facility
Fremont, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
New Haven, Connecticut, United States
Unknown Facility
Aventura, Florida, United States
Unknown Facility
Augusta, Georgia, United States
Unknown Facility
Snellville, Georgia, United States
Unknown Facility
Evansville, Indiana, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Fridley, Minnesota, United States
Unknown Facility
Paramus, New Jersey, United States
Unknown Facility
Mount Kisco, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
High Point, North Carolina, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Arlington, Texas, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
College Station, Texas, United States
Unknown Facility
Plano, Texas, United States
Unknown Facility
Webster, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ira Lawrence, MD
Medicis Pharmaceutical
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2012
First Posted
October 11, 2012
Study Start
September 1, 2012
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
January 9, 2013
Record last verified: 2013-01