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

Information source: Galderma R&D
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acne Vulgaris

Intervention: CD1579 2.5% (Drug); CD1579 5% (Drug); Vehicle (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Galderma R&D

Summary

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.

Clinical Details

Official title: A Multicenter, Randomized, Double-blinded, Vehicle-controlled Parallel Group Efficacy and Safety Study of 2 Different Concentrations of CD1579 Gels Versus Vehicle in the Treatment of Acne Vulgaris.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Percent reduction in total lesion counts

Secondary outcome: Percent of Subjects With Adverse Events will be evaluated

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Galderma investigational site, Fukuoka, Japan

Galderma investigational site, Amagasaki, Hyogo, Japan

Galderma investigational site, Kobe, Hyogo, Japan

Galderma investigational site, Nakano, Tokyo, Japan

Galderma investigational site, Shibuya, Tokyo, Japan

Galderma investigational site, Shinjuku, Tokyo, Japan

Additional Information

Starting date: March 2014
Last updated: November 17, 2014

Page last updated: August 23, 2015

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