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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02073461
First Posted: February 27, 2014
Last Update Posted: March 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Galderma R&D
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Changes From Baseline in Total Lesion Counts [ Time Frame: Baseline - Week 12 ]
    Median percent reductions from Baseline in total lesion count (ITT-LOCF)


Secondary Outcome Measures:
  • Percent of Subjects With Adverse Events [ Time Frame: up to 12 weeks ]
    Adverse events which were observed in 5% or more patients with either group are listed.

  • Local Tolerability (Erythema) [ Time Frame: 12 weeks ]
    Highest severity of local tolerability scores worse than Baseline

  • Local Tolerability (Scaling) [ Time Frame: 12 weeks ]
    Highest severity of local tolerability scores worse than Baseline

  • Local Tolerability (Dryness) [ Time Frame: 12 weeks ]
    Highest severity of local tolerability scores worse than Baseline

  • Local Tolerability (Pruritus) [ Time Frame: 12 weeks ]
    Highest severity of local tolerability scores worse than Baseline

  • Local Tolerability (Stinging/Burning) [ Time Frame: 12 weeks ]
    Highest severity of local tolerability scores worse than Baseline


Enrollment: 236
Study Start Date: March 2014
Study Completion Date: October 2014
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT02073461     History of Changes
Other Study ID Numbers: RDT.07.SPR.27124
First Submitted: February 20, 2014
First Posted: February 27, 2014
Results First Submitted: September 15, 2016
Results First Posted: November 3, 2016
Last Update Posted: March 28, 2017
Last Verified: February 2017

Keywords provided by Galderma R&D:
Acne Vulgaris

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Benzoyl Peroxide
Dermatologic Agents