Study STF115287, a Clinical Confirmation Study of GSK2585823 in the Treatment of Acne Vulgaris in Japanese Subjects
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ClinicalTrials.gov Identifier: NCT01445301 |
Recruitment Status :
Completed
First Posted : October 3, 2011
Results First Posted : April 27, 2018
Last Update Posted : April 27, 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: GSK2585823(CLDM 1%-BPO 3% gel) Drug: CLDM 1% gel twice daily |
Enrollment | 800 |
Participant Flow
Recruitment Details | A total of 800 Japanese participants across 26 investigational centers in Japan, with Acne Vulgaris were enrolled in this study. The study was conducted from 27 September 2011 - 02 August 2012. |
Pre-assignment Details |
Arm/Group Title | GSK2585823 Once Daily | GSK2585823 Twice Daily | CLDM Twice Daily |
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Participants were instructed to apply GSK2585823 (Topical gel in 1 gram (g) containing clindamycin (CLDM) 10 milligram (mg) and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU (Finger Tip Unit). | Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. | Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. |
Period Title: Overall Study | |||
Started | 204 | 297 | 299 |
Completed | 183 | 262 | 290 |
Not Completed | 21 | 35 | 9 |
Reason Not Completed | |||
Adverse Event | 15 | 25 | 4 |
Lack of Efficacy | 0 | 1 | 0 |
Protocol Violation | 1 | 0 | 0 |
Protocol-Defined Stopping Criteria | 0 | 1 | 1 |
Physician Decision | 0 | 2 | 0 |
Withdrawal by Subject | 5 | 6 | 4 |
Baseline Characteristics
Arm/Group Title | GSK2585823 Once Daily | GSK2585823 Twice Daily | CLDM Twice Daily | Total | |
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Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. | Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. | Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. | Total of all reporting groups | |
Overall Number of Baseline Participants | 204 | 296 | 299 | 799 | |
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Intent-to-treat (ITT) population comprised all randomized participants who received at least one application of investigational product. One participant excluded was randomized but was not administered study drug. 799 participant were included in the ITT population.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 204 participants | 296 participants | 299 participants | 799 participants | |
20.4 (6.06) | 20.7 (6.33) | 21.1 (6.55) | 20.8 (6.34) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 204 participants | 296 participants | 299 participants | 799 participants | |
Female |
139 68.1%
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187 63.2%
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202 67.6%
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528 66.1%
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Male |
65 31.9%
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109 36.8%
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97 32.4%
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271 33.9%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 204 participants | 296 participants | 299 participants | 799 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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0 0.0%
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Asian |
204 100.0%
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296 100.0%
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299 100.0%
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799 100.0%
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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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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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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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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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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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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: | NCT01445301 |
Other Study ID Numbers: |
115287 |
First Submitted: | September 15, 2011 |
First Posted: | October 3, 2011 |
Results First Submitted: | April 11, 2017 |
Results First Posted: | April 27, 2018 |
Last Update Posted: | April 27, 2018 |