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 |
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
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2095 Langhorne Road
Lynchburg, Virginia 24501
Lynchburg, Virginia 24501
434-847-8400
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611 NE Main Street
Simpsonville, South Carolina 29681
Simpsonville, South Carolina 29681
864-962-0431
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PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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