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
Omaha, Nebraska 68144
1291
mi
from 91732
Omaha, NE
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2095 Langhorne Road
Lynchburg, Virginia 24501
434-847-8400
2174
mi
from 91732
Lynchburg, VA
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611 NE Main Street
Simpsonville, South Carolina 29681
864-962-0431
2027
mi
from 91732
Simpsonville, SC
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Albuquerque, New Mexico 87106
651
mi
from 91732
Albuquerque, NM
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Arlington, Texas 76011
1208
mi
from 91732
Arlington, TX
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Birmingham, Alabama 35205
1784
mi
from 91732
Birmingham, AL
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Evansville, Indiana 47713
1715
mi
from 91732
Evansville, IN
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Ft. Gratiot, Michigan 48059
2000
mi
from 91732
Ft. Gratiot, MI
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Glendale, California 91206
14
mi
from 91732
Glendale, CA
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High Point, North Carolina 27262
2141
mi
from 91732
High Point, NC
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1352
mi
from 91732
Houston, TX
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Houston, Texas 77030
1357
mi
from 91732
Houston, TX
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Louisville, Kentucky 40202
1813
mi
from 91732
Louisville, KY
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Marina Del Rey, California 90292
25
mi
from 91732
Marina Del Rey, CA
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Miami, Florida 33175
2320
mi
from 91732
Miami, FL
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Miramar, Florida 33027
2314
mi
from 91732
Miramar, FL
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Newnan, Georgia 30263
1900
mi
from 91732
Newnan, GA
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Norman, Oklahoma 73069
1169
mi
from 91732
Norman, OK
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Portland, Oregon 97210
829
mi
from 91732
Portland, OR
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Salt Lake City, Utah 84124
568
mi
from 91732
Salt Lake City, UT
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San Antonio, Texas 78229
1188
mi
from 91732
San Antonio, TX
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San Diego, California 92123
101
mi
from 91732
San Diego, CA
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Troy, Michigan 48084
1961
mi
from 91732
Troy, MI
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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...
2275
mi
from 91732
Wilmington, NC
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