A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00964223 |
Recruitment Status :
Completed
First Posted : August 24, 2009
Results First Posted : August 25, 2011
Last Update Posted : November 23, 2016
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Sponsor:
Stiefel, a GSK Company
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
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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: Clindamycin and benzoyl peroxide gel (Duac® Topical Gel) Drug: benzoyl peroxide and adapalene gel (EPIDUO™ Gel) |
Enrollment | 28 |
Participant Flow
Recruitment Details | Clinical research centers |
Pre-assignment Details |
Arm/Group Title | All Study Participants |
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Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks. |
Period Title: Split Face Treatment (Weeks 1 and 2) | |
Started | 28 |
Completed | 28 |
Not Completed | 0 |
Period Title: Full Face Treatment (Weeks 5 and 8) | |
Started | 28 |
Completed | 27 |
Not Completed | 1 |
Reason Not Completed | |
Lost to Follow-up | 1 |
Baseline Characteristics
Arm/Group Title | All Study Participants | |
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Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks. | |
Overall Number of Baseline Participants | 28 | |
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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 | 28 participants | |
29.6 (9.5) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 28 participants | |
Female |
24 85.7%
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Male |
4 14.3%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 28 participants |
Asian | 2 | |
Black or African American | 11 | |
White | 15 | |
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 28 participants |
28 | ||
Investigators Static Global Assessment (ISGA)
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 28 participants |
Mild | 2 | |
Moderate | 20 | |
Severe | 6 | |
[1]
Measure Description: Patients with the following ISGA grades were eligible for enrollment on this study: 0, Clear: clear skin with no inflammatory lesions (IL) or non-inflammatory lesions (NIL); 1, Almost clear: rare NIL with no more than one small IL; 2, Mild: some NIL with no more than a few IL (papules/pustules only, no nodular lesions); 3, Moderate: up to many NIL and may have some IL, but no more than one small nodular lesion; 4, Severe: up to many NIL and IL, but no more than a few small nodular lesions; 5, Very severe: many NIL and IL and more than a few nodular lesions. May have cystic lesions.
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Inflammatory Acne Lesion Count
[1] Mean (Standard Deviation) Unit of measure: Inflammatory Lesion |
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Number Analyzed | 28 participants | |
21.5 (9.3) | ||
[1]
Measure Description: Inflammatory acne lesion count at baseline (number of pustules and papules).
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Non-Inflammatory Acne Lesion Count
[1] Mean (Standard Deviation) Unit of measure: Non-Inflammatory lesion |
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Number Analyzed | 28 participants | |
33.0 (24.7) | ||
[1]
Measure Description: Non-Inflammatory acne lesion count at baseline (number of whiteheads and blackheads)
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Total Acne Lesion Count
[1] Mean (Standard Deviation) Unit of measure: Acne lesions |
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Number Analyzed | 28 participants | |
54.5 (27.1) | ||
[1]
Measure Description: Total acne lesion count (includes inflammatory and non-inflammatory lesions)
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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 ( Stiefel, a GSK Company ) |
ClinicalTrials.gov Identifier: | NCT00964223 |
Other Study ID Numbers: |
114547 |
First Submitted: | August 20, 2009 |
First Posted: | August 24, 2009 |
Results First Submitted: | September 7, 2010 |
Results First Posted: | August 25, 2011 |
Last Update Posted: | November 23, 2016 |