A Efficacy and Safety of Duac™Compared With Clindamycin Phosphate Gel in the Treatment of Mild to Moderate Acne Vulgaris
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ClinicalTrials.gov Identifier: NCT01915732 |
Recruitment Status :
Completed
First Posted : August 5, 2013
Results First Posted : November 25, 2014
Last Update Posted : February 28, 2017
|
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 (Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Acne Vulgaris |
Interventions |
Drug: Duac™Once Daily Gel Drug: 1% clindamycin phosphate gel |
Enrollment | 1018 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Duac Once Daily Gel | Dalin Gel |
---|---|---|
Arm/Group Description | Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks. | Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks. |
Period Title: Overall Study | ||
Started | 500 | 516 |
Completed | 430 | 445 |
Not Completed | 70 | 71 |
Reason Not Completed | ||
Withdrawal by Subject | 18 | 18 |
Failure to Meet Randomization Criteria | 1 | 0 |
Adverse Event | 12 | 4 |
Protocol Violation | 5 | 5 |
Lack of Efficacy | 6 | 11 |
Lost to Follow-up | 22 | 26 |
Par. Improved, Voluntary (Vol) exit | 1 | 0 |
Par. Conscious Ineffective Vol Exit | 1 | 0 |
Drug Release Error | 1 | 0 |
Recovered | 1 | 0 |
Pregnancy | 1 | 0 |
Poor Perceived Efficacy | 1 | 0 |
Par. Unable to Come to the Hospital | 0 | 1 |
Got Well | 0 | 1 |
Par. not Willing to Continue Treatment | 0 | 1 |
Par. Refused to Hospital Visits | 0 | 1 |
Job Transfer | 0 | 1 |
Improper Facial Procedure | 0 | 1 |
Poor Conscious Effect | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Duac Once Daily Gel | Dalin Gel | Total | |
---|---|---|---|---|
Arm/Group Description | Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks. | Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks. | Total of all reporting groups | |
Overall Number of Baseline Participants | 500 | 516 | 1016 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 500 participants | 516 participants | 1016 participants | |
23.4 (4.64) | 23.3 (4.29) | 23.4 (4.46) | ||
Gender
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 500 participants | 516 participants | 1016 participants | |
Female |
382 76.4%
|
383 74.2%
|
765 75.3%
|
|
Male |
118 23.6%
|
133 25.8%
|
251 24.7%
|
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 500 participants | 516 participants | 1016 participants |
Asian | 500 | 515 | 1015 | |
White | 0 | 1 | 1 |
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01915732 |
Other Study ID Numbers: |
114543 |
First Submitted: | April 5, 2013 |
First Posted: | August 5, 2013 |
Results First Submitted: | November 20, 2014 |
Results First Posted: | November 25, 2014 |
Last Update Posted: | February 28, 2017 |