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
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Sponsor:
Galderma R&D
Information provided by (Responsible Party):
Galderma R&D
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Tracking Information | |||
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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 |
Percent Changes From Baseline in Total Lesion Counts [ Time Frame: Baseline - Week12 ] | ||
Original Primary Outcome Measures ICMJE |
Percent Reduction in Total Lesion Counts [ Time Frame: 12 weeks ] | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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 |
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Condition ICMJE | Acne Vulgaris | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
417 | ||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |