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Efficacy and Safety Study of GK530G Versus CD0271 0.1% Gel and CD1579 2.5% Gel in the Treatment of Acne Vulgaris.

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ClinicalTrials.gov Identifier: NCT02073448
Recruitment Status : Completed
First Posted : February 27, 2014
Results First Posted : November 3, 2016
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Tracking Information
First Submitted Date  ICMJE February 20, 2014
First Posted Date  ICMJE February 27, 2014
Results First Submitted Date  ICMJE September 15, 2016
Results First Posted Date  ICMJE November 3, 2016
Last Update Posted Date March 28, 2017
Study Start Date  ICMJE March 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2017)
Percent Changes From Baseline in Total Lesion Counts [ Time Frame: Baseline - Week12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 25, 2014)
Percent Reduction in Total Lesion Counts [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2016)
  • Percent of Subjects With Adverse Events [ Time Frame: up to 12 weeks ]
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2014)
Percent of Subjects With Adverse Events [ Time Frame: up to 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of GK530G Versus CD0271 0.1% Gel and CD1579 2.5% Gel in the Treatment of Acne Vulgaris.
Official Title  ICMJE A Multicenter, Randomized, Double-blinded, Active-controlled Parallel Group Efficacy and Safety Study of GK530G Versus CD0271 0.1% Gel and CD1579 2.5% Gel in the Treatment of Acne Vulgaris.
Brief Summary This study is to demonstrate the superiority in efficacy of the GK530G (fixed combination of CD0271 0.1% and CD1579 2.5%) versus each of the monads (CD0271 0.1% and CD1579 2.5%) in the treatment of acne vulgaris for up to 12 weeks, in the Japanese patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: GK530G
    Other Name: Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
  • Drug: CD0271
    Other Name: Adapalene 0.1% Gel
  • Drug: CD1579
    Other Name: Benzoyl Peroxide 2.5% Gel
Study Arms  ICMJE
  • Experimental: GK530G
    Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
    Intervention: Drug: GK530G
  • Active Comparator: CD0271
    Adapalene 01% Gel
    Intervention: Drug: CD0271
  • Active Comparator: CD1579
    Benzoyl Peroxide 2.5% Gel
    Intervention: Drug: CD1579
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 17, 2014)
417
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2014)
412
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02073448
Other Study ID Numbers  ICMJE RDT.07.SPR.27123
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Galderma R&D
Study Sponsor  ICMJE Galderma R&D
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Galderma R&D
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP