Dose Range Study of CD5789 in Acne Vulgaris

Completed · Phase 2

Conditions studied: Acne Vulgaris

In brief

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

Key facts

Study ID

NCT01616654

Run by

Galderma R&D

People needed

304

Starts

2012-06-20

Expected to finish

2014-06-12

Last updated by the study team

2021-09-20

Who can join

Age: 12 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participant, 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: Participants of Japanese origin with at least 20 inflammatory lesions and up to four nodules on the face.
• Note: Participants 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.

You may not qualify if…

• 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 participant at significant risk (according to the Investigator's judgment) if the participant 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.

Where it is running

• Total Skin and Beauty Dermatology Center, PC — Birmingham, Alabama, United States
• Parexel Early Phase — Glendale, California, United States
• Odyssey Medispa — Marina del Rey, California, United States
• Rady Children's Hospital — San Diego, California, United States
• FXM Research Corp Miami — Miami, Florida, United States
• FMX Research Miramar — Miramar, Florida, United States
• Meda Phase, Inc — Newnan, Georgia, United States
• Deaconess Clinic, Inc. — Evansville, Indiana, United States
• Dermatology Specialists PC — Louisville, Kentucky, United States
• Hamzavi Dermatology — Fort Gratiot, Michigan, United States
• Somerset Skin Centre — Troy, Michigan, United States
• Skin Specialists, PC — Omaha, Nebraska, United States
• Academic Dermatology Associates — Albuquerque, New Mexico, United States
• Zoe Drealos, MD — High Point, North Carolina, United States
• PMG Research of Wilmington — Wilmington, North Carolina, United States
• Central Sooner Research — Norman, Oklahoma, United States
• Oregon Dermatology and Research Center — Portland, Oregon, United States
• Palmetto Clinical Trial Services, LLC — Greenville, South Carolina, United States
• Arlington Center for Dermatology — Arlington, Texas, United States
• Suzanne Bruce and Associates P.A. The Center for Skin Research — Houston, Texas, United States
• Stephen Miller MD — San Antonio, Texas, United States
• Center for Clinical Studies — Webster, Texas, United States
• Dermatology Research Center — Salt Lake City, Utah, United States
• The Education & Research Foundation, Inc. — Lynchburg, Virginia, United States

Full record on ClinicalTrials.gov

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