Safety and Efficacy Study in Subjects With Seborrheic Dermatitis

NCT ID: NCT01703793

Last Updated: 2013-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-01-31

Brief Summary

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

Detailed Description

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Conditions

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Seborrheic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vehicle

Vehicle (placebo) treatment, twice a week for four weeks.

Group Type PLACEBO_COMPARATOR

Vehicle (placebo)

Intervention Type DRUG

Test Product 10156

Product 10156 treatment, twice a week for four weeks.

Group Type EXPERIMENTAL

Test Product 10156

Intervention Type DRUG

Test Product 49778

Product 49778 treatment, twice a week for four weeks.

Group Type EXPERIMENTAL

Test Product 49778

Intervention Type DRUG

Interventions

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Test Product 49778

Intervention Type DRUG

Test Product 10156

Intervention Type DRUG

Vehicle (placebo)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medicis Global Service Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ira Lawrence, MD

Role: STUDY_CHAIR

Medicis Pharmaceutical

Locations

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Fremont, California, United States

Site Status

Los Angeles, California, United States

Site Status

San Diego, California, United States

Site Status

New Haven, Connecticut, United States

Site Status

Aventura, Florida, United States

Site Status

Augusta, Georgia, United States

Site Status

Snellville, Georgia, United States

Site Status

Evansville, Indiana, United States

Site Status

Detroit, Michigan, United States

Site Status

Fridley, Minnesota, United States

Site Status

Paramus, New Jersey, United States

Site Status

Mount Kisco, New York, United States

Site Status

New York, New York, United States

Site Status

High Point, North Carolina, United States

Site Status

Portland, Oregon, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Arlington, Texas, United States

Site Status

Austin, Texas, United States

Site Status

College Station, Texas, United States

Site Status

Plano, Texas, United States

Site Status

Webster, Texas, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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MP-1001-01

Identifier Type: -

Identifier Source: org_study_id

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