Safety and Efficacy Study in Subjects With Seborrheic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medicis Global Service Corporation
ClinicalTrials.gov Identifier:
NCT01703793
First received: October 7, 2012
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Seborrheic Dermatitis
Drug: Test Product 49778
Drug: Test Product 10156
Drug: Vehicle (placebo)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by Medicis Global Service Corporation:

Primary Outcome Measures:
  • Symptom Improvement (investigator assessment) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]
    Assess the change in the pruritus score from baseline to week 2 and to week 4.


Enrollment: 240
Study Start Date: September 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Vehicle
Vehicle (placebo) treatment, twice a week for four weeks.
Drug: Vehicle (placebo)
Experimental: Test Product 10156
Product 10156 treatment, twice a week for four weeks.
Drug: Test Product 10156
Experimental: Test Product 49778
Product 49778 treatment, twice a week for four weeks.
Drug: Test Product 49778

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01703793

Locations
United States, California
Fremont, California, United States
Los Angeles, California, United States
San Diego, California, United States
United States, Connecticut
New Haven, Connecticut, United States
United States, Florida
Aventura, Florida, United States
United States, Georgia
Augusta, Georgia, United States
Snellville, Georgia, United States
United States, Indiana
Evansville, Indiana, United States
United States, Michigan
Detroit, Michigan, United States
United States, Minnesota
Fridley, Minnesota, United States
United States, New Jersey
Paramus, New Jersey, United States
United States, New York
Mount Kisco, New York, United States
New York, New York, United States
United States, North Carolina
High Point, North Carolina, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas
Arlington, Texas, United States
Austin, Texas, United States
College Station, Texas, United States
Plano, Texas, United States
Webster, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
Sponsors and Collaborators
Medicis Global Service Corporation
Investigators
Study Chair: Ira Lawrence, MD Medicis Pharmaceutical
  More Information

No publications provided

Responsible Party: Medicis Global Service Corporation
ClinicalTrials.gov Identifier: NCT01703793     History of Changes
Other Study ID Numbers: MP-1001-01
Study First Received: October 7, 2012
Last Updated: January 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Seborrheic
Skin Diseases
Sebaceous Gland Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on August 21, 2014