Safety and Efficacy Study in Subjects With Seborrheic Dermatitis

January 7, 2013 updated by: Medicis Global Service Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fremont, California, United States
      • Los Angeles, California, United States
      • San Diego, California, United States
    • Connecticut
      • New Haven, Connecticut, United States
    • Florida
      • Aventura, Florida, United States
    • Georgia
      • Augusta, Georgia, United States
      • Snellville, Georgia, United States
    • Indiana
      • Evansville, Indiana, United States
    • Michigan
      • Detroit, Michigan, United States
    • Minnesota
      • Fridley, Minnesota, United States
    • New Jersey
      • Paramus, New Jersey, United States
    • New York
      • Mount Kisco, New York, United States
      • New York, New York, United States
    • North Carolina
      • High Point, North Carolina, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • Texas
      • Arlington, Texas, United States
      • Austin, Texas, United States
      • College Station, Texas, United States
      • Plano, Texas, United States
      • Webster, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom Improvement (investigator assessment)
Time Frame: 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
Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom Improvement (subject assessment)
Time Frame: Weeks 2 and 4
Assess the change in the pruritus score from baseline to week 2 and to week 4.
Weeks 2 and 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medicis Global Service Corporation

Investigators

  • Study Chair: Ira Lawrence, MD, Medicis Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

October 7, 2012

First Submitted That Met QC Criteria

October 7, 2012

First Posted (Estimate)

October 11, 2012

Study Record Updates

Last Update Posted (Estimate)

January 9, 2013

Last Update Submitted That Met QC Criteria

January 7, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-1001-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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