Dose Range Study of CD5789 in Acne Vulgaris

• Status: Completed
• Trial end date: 2014-06-12
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma; Galderma R&D
• Treatments: Nicotinic Acids; Tazarotene; Trifarotene

Criteria

Inclusion Criteria:

• 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.

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 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.