DUAC® Early Onset Efficacy Study in Japanese Subjects
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ClinicalTrials.gov Identifier: NCT02557399 |
Recruitment Status :
Completed
First Posted : September 23, 2015
Results First Posted : February 15, 2018
Last Update Posted : August 20, 2018
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment |
Condition |
Acne Vulgaris |
Interventions |
Drug: Duac® fixed dose combination gel Drug: ADA 0.1% gel Drug: CLDM 1% gel |
Enrollment | 350 |
Participant Flow
Recruitment Details | DUAC® (clindamycin phosphate 1.2 percent [%] + benzoyl peroxide 3%) is the registered product of GlaxoSmithKline. This study was conducted between 07 October 2015 and 17 February 2016 in which 349 participants were randomized. |
Pre-assignment Details |
Arm/Group Title | DUAC | ADA 0.1% +CLDM 1% |
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Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 finger tip unit (FTU) about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks. | Participants were instructed to use combination therapy of Adapalene (ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and clindamycin (CLDM) 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to inflammatory lesions (ILs) only. |
Period Title: Overall Study | ||
Started | 172 | 177 |
Completed | 165 | 169 |
Not Completed | 7 | 8 |
Reason Not Completed | ||
Adverse Event | 6 | 5 |
Protocol Violation | 0 | 1 |
Protocol-defined stopping criteria | 0 | 1 |
Withdrawal by Subject | 1 | 1 |
Baseline Characteristics
Arm/Group Title | DUAC | ADA 0.1% +CLDM 1% | Total | |
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Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity equal to about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks. | Participants were instructed to use combination therapy of ADA 0.1% gel with quantity equal to about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only. | Total of all reporting groups | |
Overall Number of Baseline Participants | 172 | 177 | 349 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 172 participants | 177 participants | 349 participants | |
20.3 (5.91) | 19.8 (4.90) | 20.0 (5.42) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 172 participants | 177 participants | 349 participants | |
Female |
97 56.4%
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110 62.1%
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207 59.3%
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Male |
75 43.6%
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67 37.9%
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142 40.7%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 172 participants | 177 participants | 349 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
172 100.0%
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177 100.0%
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349 100.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
0 0.0%
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0 0.0%
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0 0.0%
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White |
0 0.0%
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0 0.0%
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0 0.0%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: | GSK Response Center |
Organization: | GlaxoSmithKline |
Phone: | 866-435-7343 |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT02557399 |
Other Study ID Numbers: |
201884 |
First Submitted: | June 11, 2015 |
First Posted: | September 23, 2015 |
Results First Submitted: | February 24, 2017 |
Results First Posted: | February 15, 2018 |
Last Update Posted: | August 20, 2018 |