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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Galderma R&D
ClinicalTrials.gov Identifier:
NCT02073461
First received: February 20, 2014
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Acne Vulgaris
Drug: CD1579 2.5%
Drug: CD1579 5%
Drug: Vehicle
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Galderma R&D:

Primary Outcome Measures:
  • Percent reduction in total lesion counts [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent of Subjects With Adverse Events will be evaluated [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 234
Study Start Date: March 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CD1579 2.5%
Benzoyl Peroxide 2.5%
Drug: CD1579 2.5%
Other Name: Benzoyl Peroxide 2.5%
Experimental: CD1579 5%
Benzoyl Peroxide 5%
Drug: CD1579 5%
Other Name: Benzoyl Peroxide 5%
Placebo Comparator: Vehicle
Vehicle
Drug: Vehicle
Other Name: Vehicle

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02073461

Locations
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
Galderma investigational site
Fukuoka, Japan
Sponsors and Collaborators
Galderma R&D
  More Information

No publications provided

Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT02073461     History of Changes
Other Study ID Numbers: RDT.07.SPR.27124
Study First Received: February 20, 2014
Last Updated: June 16, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Galderma R&D:
Acne Vulgaris

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Benzoyl Peroxide
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014