Efficacy and Safety Study of 2 Different Concentrations of CD1579 Gels Versus Vehicle in the Treatment of Acne Vulgaris.

Galderma

Status and phase: Completed; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: Vehicle; Drug: CD1579 5%; Drug: CD1579 2.5%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02073461

RDT.07.SPR.27124

Details and patient eligibility

About

This study is to assess the efficacy and safety of two concentrations of CD1579 (2.5% and 5%) versus vehicle in the treatment of acne vulgaris in the Japanese patients.

Enrollment: 236 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women at the age of 12 or older at the Screening visit.
• Those with clinical diagnosis of acne vulgaris with more than 20 noninflammatory lesions (open and closed comedones) and 12 to 100 (inclusive) inflammatory lesions (papules, pustules and nodules) on the face (forehead, both cheeks, nose and chin).

Exclusion criteria

• Those with more than two nodular acne lesions or any cysts.
• Those with the diagnosis of any acne conglobata, any acne fulminans, any chloracne, or any drug induced acne.
• Those who have clinically significant abnormal findings or conditions on skin other than acne such as atopic dermatitis, perioral dermatitis, or rosacea that potentially interfere with study assessments according to Investigator's judgment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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236 participants in 3 patient groups, including a placebo group

CD1579 2.5%

Experimental group

Description:

Benzoyl Peroxide 2.5%

Treatment:

Drug: CD1579 2.5%

CD1579 5%

Experimental group

Description:

Benzoyl Peroxide 5%

Treatment:

Drug: CD1579 5%

Vehicle

Placebo Comparator group

Description:

Vehicle

Treatment:

Drug: Vehicle