Dose Range Study of CD5789 in Acne Vulgaris



Status:Completed
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:12 - 35
Updated:3/30/2013
Start Date:June 2012
End Date:September 2013
Contact:Clincal Trial Administrator
Email:clinicaltrials@galderma.com
Phone:609-860-8298

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A Randomized, Multi-center, Investigator-blind, Vehicle- and Active-controlled, Phase 2 Study to Assess the Efficacy and Safety of Different Concentrations of CD5789 Cream Applied Once Daily in Subjects With Moderate to Severe Acne Vulgaris


To assess the efficacy and safety of different concentrations of CD5789 cream in subjects
with acne vulgaris for the purpose of dose identification.


Inclusion Criteria:

- Male or female subject, 12 to 35 years old with the following characteristics:

- Facial acne severity grade of the following:

- Stratum 1: IGA score of 3 or 4

- Stratum 2: IGA score of 4

- Stratum 3: IGA score of 3 or 4

- A minimum of 30 non-inflammatory lesions and fulfills the criteria of one of the
following strata:

- Stratum 1: A minimum of 20 but not more than 40 inflammatory lesions, and a
maximum of one nodule on the face.

- Stratum 2: More than 40 inflammatory lesions, and up to four nodules on the
face.

- Stratum 3: Subjects of Japanese origin with at least 20 inflammatory lesions and
up to four nodules on the face.

- Note: Subjects of Japanese origin will not be included in Stratum 1 or
Stratum 2. Japanese origin is defined as all four grandparents were born in
Japan.

Exclusion Criteria:

- The presence of severe forms of acne (acne conglobata, acne fulminans) or secondary
acne form (chloracne, drug-induced acne, etc.)

- Any uncontrolled or serious disease, or any medical or surgical condition, that may
either interfere with the interpretation of the clinical trial results and/or put the
subject at significant risk (according to the Investigator's judgment) if the subject
participates in the clinical trial.

- Known or suspected allergies or sensitivities to any components of any of the study
drugs.

- Current participation in any other clinical trial of a drug or device OR past
participation within the 30 days prior to the Baseline visit.
We found this trial at
24
sites
Evansville, Indiana 47713
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2095 Langhorne Road
Lynchburg, Virginia 24501
434-847-8400
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611 NE Main Street
Simpsonville, South Carolina 29681
864-962-0431
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Albuquerque, New Mexico 87106
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Arlington, Texas 76011
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Birmingham, Alabama 35205
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Ft. Gratiot, Michigan 48059
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Glendale, California 91206
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High Point, North Carolina 27262
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Houston, TX
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Houston, Texas 77030
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Louisville, Kentucky 40202
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Marina Del Rey, California 90292
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Miami, Florida 33175
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Miramar, Florida 33027
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Newnan, Georgia 30263
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Norman, Oklahoma 73069
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Omaha, Nebraska 68144
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Portland, Oregon 97210
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Salt Lake City, Utah 84124
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San Antonio, Texas 78229
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San Diego, California 92123
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Troy, Michigan 48084
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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Wilmington, NC
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