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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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
Acne Vulgaris |
Interventions |
Drug: GK530G Drug: CD0271 Drug: CD1579 |
Enrollment | 417 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | CD0271 | GK530G | CD1579 |
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Adapalene 01% Gel CD0271 |
Fixed-dose combination gel of Adapalene and Benzoyl Peroxide GK530G |
Benzoyl Peroxide 2.5% Gel CD1579 |
Period Title: Overall Study | |||
Started | 101 | 212 | 104 |
Completed | 99 | 200 | 99 |
Not Completed | 2 | 12 | 5 |
Baseline Characteristics
Arm/Group Title | GK530G | CD0271 | CD1579 | Total | |
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Fixed-dose combination gel of Adapalene and Benzoyl Peroxide GK530G |
Adapalene 01% Gel CD0271 |
Benzoyl Peroxide 2.5% Gel CD1579 |
Total of all reporting groups | |
Overall Number of Baseline Participants | 212 | 101 | 104 | 417 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 212 participants | 101 participants | 104 participants | 417 participants | |
<=18 years |
116 54.7%
|
56 55.4%
|
56 53.8%
|
228 54.7%
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Between 18 and 65 years |
96 45.3%
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45 44.6%
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48 46.2%
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189 45.3%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 212 participants | 101 participants | 104 participants | 417 participants | |
19.7 (6.5) | 19.6 (6.0) | 19.3 (5.4) | 19.6 (6.1) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 212 participants | 101 participants | 104 participants | 417 participants | |
Female |
141 66.5%
|
67 66.3%
|
74 71.2%
|
282 67.6%
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Male |
71 33.5%
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34 33.7%
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30 28.8%
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135 32.4%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Japan | Number Analyzed | 212 participants | 101 participants | 104 participants | 417 participants |
212 | 101 | 104 | 417 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Clinical Project Manager |
Organization: | Galderma K.K |
Phone: | +81 3 5937 3850 |
EMail: | GaldermaKK.ClinDev@galderma.com |
Responsible Party: | Galderma R&D |
ClinicalTrials.gov Identifier: | NCT02073448 |
Other Study ID Numbers: |
RDT.07.SPR.27123 |
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 |