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

• 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: Galderma R&D
• Information provided by (Responsible Party): Galderma R&D

Tracking Information

• First Submitted Date: February 20, 2014
• First Posted Date: February 27, 2014
• Results First Submitted Date: September 15, 2016
• Results First Posted Date: November 3, 2016
• Last Update Posted Date: March 28, 2017
• Study Start Date: March 2014
• Actual Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 10, 2017): Percent Changes From Baseline in Total Lesion Counts [ Time Frame: Baseline - Week12 ]
• Original Primary Outcome Measures (submitted: February 25, 2014): Percent Reduction in Total Lesion Counts [ Time Frame: 12 weeks ]

Current Secondary Outcome Measures (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 (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: Efficacy and Safety Study of GK530G Versus CD0271 0.1% Gel and CD1579 2.5% Gel in the Treatment of Acne Vulgaris.
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Acne Vulgaris

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 17, 2014): 417
• Original Estimated Enrollment (submitted: February 25, 2014): 412
• Actual Study Completion Date: October 2014
• Actual Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT02073448
• Other Study ID Numbers: RDT.07.SPR.27123
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Galderma R&D
• Study Sponsor: Galderma R&D
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Galderma R&D
• Verification Date: February 2017