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Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne

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: NCT00713609
Recruitment Status : Completed
First Posted : July 11, 2008
Results First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Benzoyl peroxide gel
Drug: Clindamycin gel
Drug: Tazarotene cream
Drug: Vehicle gel
Drug: Vehicle cream
Enrollment 591
Recruitment Details In this multi-center, double-blind, vehicle controlled study, participants were assigned to one of the six treatment groups in a 2:2:2:2:2:1 ratio for 12 weeks.
Pre-assignment Details Participants with facial acne vulgaris, 12 to 45 years of age were enrolled in this study. A total of 596 participants were randomized and 587 participants received study product.
Arm/Group Title Benzoyl Peroxide/Clindamycin + Tazarotene Benzoyl Peroxide/Clindamycin + Vehicle Cream Benzoyl Peroxide Gel + Tazarotene Clindamycin Gel + Tazarotene Vehicle Gel + Tazarotene Vehicle Gel + Vehicle Cream
Hide Arm/Group Description Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face. Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face. Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face. Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face. Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
Period Title: Overall Study
Started 106 105 107 108 106 55
Completed 85 90 92 99 87 47
Not Completed 21 15 15 9 19 8
Reason Not Completed
Adverse Event             2             0             2             2             3             1
Lost to Follow-up             5             7             5             5             7             0
Lack of Efficacy             1             3             0             0             1             0
Non-Compliance with Study Treatment             1             1             2             0             1             0
Withdrawal by Subject             6             1             5             1             5             7
Protocol Violation             6             3             1             1             2             0
Arm/Group Title Benzoyl Peroxide/Clindamycin + Tazarotene Benzoyl Peroxide/Clindamycin + Vehicle Cream Benzoyl Peroxide Gel + Tazarotene Clindamycin Gel + Tazarotene Vehicle Gel + Tazarotene Vehicle Gel + Vehicle Cream Total
Hide Arm/Group Description Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face. Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face. Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face. Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face. Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face. Total of all reporting groups
Overall Number of Baseline Participants 106 105 107 108 106 55 587
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants 105 participants 107 participants 108 participants 106 participants 55 participants 587 participants
19.7  (6.6) 19.7  (6.9) 20.2  (7.3) 19.2  (6.2) 21.7  (8.4) 19.8  (6.6) 20.1  (7.1)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 105 participants 107 participants 108 participants 106 participants 55 participants 587 participants
Female
58
  54.7%
56
  53.3%
60
  56.1%
60
  55.6%
65
  61.3%
35
  63.6%
334
  56.9%
Male
48
  45.3%
49
  46.7%
47
  43.9%
48
  44.4%
41
  38.7%
20
  36.4%
253
  43.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 106 participants 105 participants 107 participants 108 participants 106 participants 55 participants 587 participants
American Indian or Alaska Native 1 0 0 0 0 0 1
Asian 8 14 5 6 9 5 47
Black 23 16 24 15 14 8 100
Multiracial 10 11 9 8 8 5 51
Native Hawaiian or Other Pacific Islander 1 1 1 0 1 0 4
White 63 63 68 79 74 37 384
1.Primary Outcome
Title Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12
Hide Description The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts [only post-Baseline]) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).
Time Frame Baseline and up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) Analysis Set: all randomized participants who received study product and reached Week 12.
Arm/Group Title Benzoyl Peroxide/Clindamycin + Tazarotene Benzoyl Peroxide/Clindamycin + Vehicle Cream Benzoyl Peroxide Gel + Tazarotene Clindamycin Gel + Tazarotene Vehicle Gel + Tazarotene Vehicle Gel + Vehicle Cream
Hide Arm/Group Description:
Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
Overall Number of Participants Analyzed 106 105 107 107 106 55
Mean (Standard Deviation)
Unit of Measure: Lesion count
ILC, n=101, 103, 105, 105, 104, 52 -16.8  (14.35) -18.1  (14.45) -18.9  (12.84) -18.8  (11.49) -14.5  (12.76) -8.96  (12.63)
NILC, n=101, 103, 105, 105, 104, 52 -33.0  (23.94) -24.9  (33.41) -37.1  (29.70) -37.5  (29.51) -33.0  (25.89) -18.9  (28.41)
TLC, n=101, 103, 105, 105, 104, 52 -49.8  (31.78) -43.0  (42.24) -56.0  (34.99) -56.3  (35.42) -47.6  (33.32) -27.8  (35.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Benzoyl Peroxide/Clindamycin + Vehicle Cream
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.692
Comments For ILC
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Benzoyl Peroxide Gel + Tazarotene
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.467
Comments For ILC
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Clindamycin Gel + Tazarotene
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.281
Comments For ILC
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Vehicle Gel + Tazarotene
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.075
Comments For ILC
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Vehicle Gel + Vehicle Cream
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments For ILC
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Benzoyl Peroxide/Clindamycin + Vehicle Cream
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments For NILC
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Benzoyl Peroxide Gel + Tazarotene
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.803
Comments For NILC
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Clindamycin Gel + Tazarotene
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.175
Comments For NILC
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Vehicle Gel + Tazarotene
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.552
Comments For NILC
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Vehicle Gel + Vehicle Cream
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments For NILC
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Benzoyl Peroxide/Clindamycin + Vehicle Cream
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments For TC
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Benzoyl Peroxide Gel + Tazarotene
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.618
Comments For TC
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Clindamycin Gel + Tazarotene
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.149
Comments For TC
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Vehicle Gel + Tazarotene
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.255
Comments For TC
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Vehicle Gel + Vehicle Cream
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments For TC
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Proportion of Participants With a Minimum 2-grade Improvement in the Investigator’s Static Global Assessment (ISGA) Score From Baseline to Week 12
Hide Description An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.
Time Frame Baseline and up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Benzoyl Peroxide/Clindamycin + Tazarotene Benzoyl Peroxide/Clindamycin + Vehicle Cream Benzoyl Peroxide Gel + Tazarotene Clindamycin Gel + Tazarotene Vehicle Gel + Tazarotene Vehicle Gel + Vehicle Cream
Hide Arm/Group Description:
Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
Overall Number of Participants Analyzed 106 105 107 108 106 55
Measure Type: Number
Unit of Measure: Percentage of participants
22 22 31 36 20 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Benzoyl Peroxide/Clindamycin + Vehicle Cream
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.922
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Benzoyl Peroxide Gel + Tazarotene
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.132
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Clindamycin Gel + Tazarotene
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Vehicle Gel + Tazarotene
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.706
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Vehicle Gel + Vehicle Cream
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory)
Hide Description The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).
Time Frame Baseline and up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Benzoyl Peroxide/Clindamycin + Tazarotene Benzoyl Peroxide/Clindamycin + Vehicle Cream Benzoyl Peroxide Gel + Tazarotene Clindamycin Gel + Tazarotene Vehicle Gel + Tazarotene Vehicle Gel + Vehicle Cream
Hide Arm/Group Description:
Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
Overall Number of Participants Analyzed 106 105 107 108 106 55
Mean (Standard Deviation)
Unit of Measure: Percent change
ILC, n=101, 103, 105, 105, 104, 52 -58.3  (45.57) -62.4  (39.33) -62.4  (34.83) -65.7  (33.38) -49.0  (40.90) -33.5  (41.10)
NILC, n=101, 103, 105, 105, 104, 52 -58.0  (29.97) -39.2  (51.29) -60.6  (35.00) -61.2  (31.60) -53.1  (30.56) -29.5  (44.05)
TLC, n=101, 103, 105, 105, 104, 52 -59.1  (29.96) -47.9  (38.89) -62.0  (29.42) -63.4  (28.75) -51.8  (29.18) -31.5  (37.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Benzoyl Peroxide/Clindamycin + Vehicle Cream
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.504
Comments For ILC
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Benzoyl Peroxide Gel + Tazarotene
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.504
Comments For ILC
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Clindamycin Gel + Tazarotene
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.177
Comments For ILC
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Vehicle Gel + Tazarotene
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.084
Comments For ILC
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Vehicle Gel + Vehicle Cream
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments For ILC
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Benzoyl Peroxide/Clindamycin + Vehicle Cream
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments For NILC
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Benzoyl Peroxide Gel + Tazarotene
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.776
Comments For NILC
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Clindamycin Gel + Tazarotene
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.465
Comments For NILC
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Vehicle Gel + Tazarotene
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.288
Comments For NILC
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Vehicle Gel + Vehicle Cream
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments For NILC
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Benzoyl Peroxide/Clindamycin + Vehicle Cream
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments For TC
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Benzoyl Peroxide Gel + Tazarotene
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.620
Comments For TC
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Clindamycin Gel + Tazarotene
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.291
Comments For TC
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Vehicle Gel + Tazarotene
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.085
Comments For TC
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Vehicle Gel + Vehicle Cream
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments For TC
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title Proportion of Participants With an ISGA Score of 0 or 1 at Week 12
Hide Description An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Benzoyl Peroxide/Clindamycin + Tazarotene Benzoyl Peroxide/Clindamycin + Vehicle Cream Benzoyl Peroxide Gel + Tazarotene Clindamycin Gel + Tazarotene Vehicle Gel + Tazarotene Vehicle Gel + Vehicle Cream
Hide Arm/Group Description:
Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
Overall Number of Participants Analyzed 106 105 107 108 106 55
Measure Type: Number
Unit of Measure: Percentage of participants
33 31 27 39 22 13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Benzoyl Peroxide/Clindamycin + Vehicle Cream
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.652
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Benzoyl Peroxide Gel + Tazarotene
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.279
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Clindamycin Gel + Tazarotene
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.312
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Vehicle Gel + Tazarotene
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.063
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Benzoyl Peroxide/Clindamycin + Tazarotene, Vehicle Gel + Vehicle Cream
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Time Frame Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 up to Day 89.
Adverse Event Reporting Description SAEs and non-serious AEs were assessed in the ITT Analysis Set.
 
Arm/Group Title Benzoyl Peroxide/Clindamycin + Tazarotene Benzoyl Peroxide/Clindamycin + Vehicle Cream Benzoyl Peroxide Gel + Tazarotene Clindamycin Gel + Tazarotene Vehicle Gel + Tazarotene Vehicle Gel + Vehicle Cream
Hide Arm/Group Description Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face. Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face. Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face. Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face. Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face. Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
All-Cause Mortality
Benzoyl Peroxide/Clindamycin + Tazarotene Benzoyl Peroxide/Clindamycin + Vehicle Cream Benzoyl Peroxide Gel + Tazarotene Clindamycin Gel + Tazarotene Vehicle Gel + Tazarotene Vehicle Gel + Vehicle Cream
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Benzoyl Peroxide/Clindamycin + Tazarotene Benzoyl Peroxide/Clindamycin + Vehicle Cream Benzoyl Peroxide Gel + Tazarotene Clindamycin Gel + Tazarotene Vehicle Gel + Tazarotene Vehicle Gel + Vehicle Cream
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/106 (0.00%)   0/105 (0.00%)   0/107 (0.00%)   0/108 (0.00%)   0/106 (0.00%)   0/55 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Benzoyl Peroxide/Clindamycin + Tazarotene Benzoyl Peroxide/Clindamycin + Vehicle Cream Benzoyl Peroxide Gel + Tazarotene Clindamycin Gel + Tazarotene Vehicle Gel + Tazarotene Vehicle Gel + Vehicle Cream
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/106 (23.58%)   22/105 (20.95%)   24/107 (22.43%)   18/108 (16.67%)   29/106 (27.36%)   12/55 (21.82%) 
Eye disorders             
Conjunctivitis  1  1/106 (0.94%)  0/105 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Gastrointestinal disorders             
Aphthous stomatitis  1  0/106 (0.00%)  1/105 (0.95%)  0/107 (0.00%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Dyspepsia  1  0/106 (0.00%)  0/105 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  1/106 (0.94%)  0/55 (0.00%) 
Lip blister  1  1/106 (0.94%)  0/105 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Nausea  1  0/106 (0.00%)  0/105 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  1/106 (0.94%)  0/55 (0.00%) 
Tooth impacted  1  1/106 (0.94%)  0/105 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Vomiting  1  1/106 (0.94%)  0/105 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
General disorders             
Application site burn  1  0/106 (0.00%)  0/105 (0.00%)  1/107 (0.93%)  0/108 (0.00%)  1/106 (0.94%)  1/55 (1.82%) 
Application site dermatitis  1  0/106 (0.00%)  0/105 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  1/106 (0.94%)  0/55 (0.00%) 
Application site discolouration  1  1/106 (0.94%)  0/105 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Application site dryness  1  1/106 (0.94%)  0/105 (0.00%)  1/107 (0.93%)  1/108 (0.93%)  1/106 (0.94%)  1/55 (1.82%) 
Application site erythema  1  1/106 (0.94%)  0/105 (0.00%)  2/107 (1.87%)  1/108 (0.93%)  0/106 (0.00%)  1/55 (1.82%) 
Application site exfoliation  1  0/106 (0.00%)  0/105 (0.00%)  1/107 (0.93%)  0/108 (0.00%)  0/106 (0.00%)  1/55 (1.82%) 
Application site irritation  1  1/106 (0.94%)  0/105 (0.00%)  3/107 (2.80%)  4/108 (3.70%)  2/106 (1.89%)  0/55 (0.00%) 
Application site pain  1  0/106 (0.00%)  0/105 (0.00%)  2/107 (1.87%)  0/108 (0.00%)  0/106 (0.00%)  2/55 (3.64%) 
Application site pruritus  1  0/106 (0.00%)  0/105 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  2/106 (1.89%)  1/55 (1.82%) 
Condition aggravated  1  0/106 (0.00%)  0/105 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  1/106 (0.94%)  0/55 (0.00%) 
Cyst  1  0/106 (0.00%)  1/105 (0.95%)  0/107 (0.00%)  1/108 (0.93%)  0/106 (0.00%)  0/55 (0.00%) 
Local swelling  1  0/106 (0.00%)  0/105 (0.00%)  0/107 (0.00%)  1/108 (0.93%)  0/106 (0.00%)  0/55 (0.00%) 
Pain  1  0/106 (0.00%)  0/105 (0.00%)  0/107 (0.00%)  1/108 (0.93%)  0/106 (0.00%)  0/55 (0.00%) 
Pyrexia  1  0/106 (0.00%)  0/105 (0.00%)  0/107 (0.00%)  1/108 (0.93%)  1/106 (0.94%)  0/55 (0.00%) 
Immune system disorders             
Allergy to arthropod bite  1  2/106 (1.89%)  0/105 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  1/106 (0.94%)  0/55 (0.00%) 
Allergy to metals  1  0/106 (0.00%)  0/105 (0.00%)  0/107 (0.00%)  1/108 (0.93%)  0/106 (0.00%)  0/55 (0.00%) 
Food allergy  1  0/106 (0.00%)  1/105 (0.95%)  0/107 (0.00%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Multiple allergies  1  0/106 (0.00%)  0/105 (0.00%)  1/107 (0.93%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Seasonal allergy  1  0/106 (0.00%)  0/105 (0.00%)  1/107 (0.93%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Infections and infestations             
Cellulitis  1  0/106 (0.00%)  1/105 (0.95%)  0/107 (0.00%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Ear infection  1  0/106 (0.00%)  0/105 (0.00%)  1/107 (0.93%)  1/108 (0.93%)  0/106 (0.00%)  0/55 (0.00%) 
Furuncle  1  0/106 (0.00%)  0/105 (0.00%)  1/107 (0.93%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Gastroenteritis  1  0/106 (0.00%)  0/105 (0.00%)  1/107 (0.93%)  1/108 (0.93%)  0/106 (0.00%)  0/55 (0.00%) 
Gastroenteritis viral  1  1/106 (0.94%)  1/105 (0.95%)  0/107 (0.00%)  1/108 (0.93%)  0/106 (0.00%)  1/55 (1.82%) 
Herpes simplex  1  1/106 (0.94%)  0/105 (0.00%)  0/107 (0.00%)  1/108 (0.93%)  0/106 (0.00%)  0/55 (0.00%) 
Hordeolum  1  1/106 (0.94%)  0/105 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Infectious mononucleosis  1  0/106 (0.00%)  1/105 (0.95%)  1/107 (0.93%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Influenza  1  1/106 (0.94%)  0/105 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  2/106 (1.89%)  0/55 (0.00%) 
Localised infection  1  0/106 (0.00%)  1/105 (0.95%)  0/107 (0.00%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Lyme disease  1  0/106 (0.00%)  0/105 (0.00%)  1/107 (0.93%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Nasopharyngitis  1  3/106 (2.83%)  3/105 (2.86%)  3/107 (2.80%)  5/108 (4.63%)  4/106 (3.77%)  3/55 (5.45%) 
Oral herpes  1  0/106 (0.00%)  1/105 (0.95%)  0/107 (0.00%)  0/108 (0.00%)  1/106 (0.94%)  0/55 (0.00%) 
Pharyngitis  1  0/106 (0.00%)  0/105 (0.00%)  1/107 (0.93%)  0/108 (0.00%)  0/106 (0.00%)  1/55 (1.82%) 
Pharyngitis streptococcal  1  1/106 (0.94%)  1/105 (0.95%)  0/107 (0.00%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Sinusitis  1  1/106 (0.94%)  1/105 (0.95%)  2/107 (1.87%)  0/108 (0.00%)  1/106 (0.94%)  2/55 (3.64%) 
Tinea pedis  1  0/106 (0.00%)  1/105 (0.95%)  0/107 (0.00%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Tonsillitis  1  0/106 (0.00%)  0/105 (0.00%)  0/107 (0.00%)  1/108 (0.93%)  0/106 (0.00%)  0/55 (0.00%) 
Upper respiratory tract infection  1  5/106 (4.72%)  4/105 (3.81%)  5/107 (4.67%)  2/108 (1.85%)  4/106 (3.77%)  1/55 (1.82%) 
Urinary tract infection  1  1/106 (0.94%)  0/105 (0.00%)  1/107 (0.93%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Vaginitis bacterial  1  0/106 (0.00%)  0/105 (0.00%)  0/107 (0.00%)  1/108 (0.93%)  0/106 (0.00%)  0/55 (0.00%) 
Viral infection  1  1/106 (0.94%)  0/105 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Viral pharyngitis  1  0/106 (0.00%)  0/105 (0.00%)  0/107 (0.00%)  1/108 (0.93%)  0/106 (0.00%)  0/55 (0.00%) 
Injury, poisoning and procedural complications             
Contusion  1  0/106 (0.00%)  0/105 (0.00%)  0/107 (0.00%)  1/108 (0.93%)  0/106 (0.00%)  0/55 (0.00%) 
Excoriation  1  0/106 (0.00%)  1/105 (0.95%)  1/107 (0.93%)  1/108 (0.93%)  0/106 (0.00%)  0/55 (0.00%) 
Facial bones fracture  1  0/106 (0.00%)  1/105 (0.95%)  0/107 (0.00%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Joint injury  1  0/106 (0.00%)  0/105 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  0/106 (0.00%)  1/55 (1.82%) 
Joint sprain  1  1/106 (0.94%)  0/105 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Muscle strain  1  1/106 (0.94%)  0/105 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Procedural pain  1  1/106 (0.94%)  1/105 (0.95%)  0/107 (0.00%)  1/108 (0.93%)  0/106 (0.00%)  0/55 (0.00%) 
Sunburn  1  0/106 (0.00%)  1/105 (0.95%)  0/107 (0.00%)  0/108 (0.00%)  1/106 (0.94%)  0/55 (0.00%) 
Investigations             
Smear cervix abnormal  1  0/106 (0.00%)  0/105 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  0/106 (0.00%)  1/55 (1.82%) 
Metabolism and nutrition disorders             
Dehydration  1  1/106 (0.94%)  0/105 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Musculoskeletal and connective tissue disorders             
Arthralgia  1  0/106 (0.00%)  0/105 (0.00%)  0/107 (0.00%)  1/108 (0.93%)  0/106 (0.00%)  0/55 (0.00%) 
Back pain  1  0/106 (0.00%)  1/105 (0.95%)  0/107 (0.00%)  0/108 (0.00%)  1/106 (0.94%)  1/55 (1.82%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Fibromatosis  1  0/106 (0.00%)  0/105 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  1/106 (0.94%)  0/55 (0.00%) 
Nervous system disorders             
Headache  1  0/106 (0.00%)  0/105 (0.00%)  1/107 (0.93%)  0/108 (0.00%)  2/106 (1.89%)  0/55 (0.00%) 
Insomnia  1  0/106 (0.00%)  0/105 (0.00%)  1/107 (0.93%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Reproductive system and breast disorders             
Menorrhagia  1  1/106 (0.94%)  0/105 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Ovarian cyst  1  1/106 (0.94%)  0/105 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Bronchitis  1  1/106 (0.94%)  0/105 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Cough  1  0/106 (0.00%)  0/105 (0.00%)  1/107 (0.93%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Epistaxis  1  0/106 (0.00%)  0/105 (0.00%)  3/107 (2.80%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Nasal congestion  1  0/106 (0.00%)  0/105 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  1/106 (0.94%)  0/55 (0.00%) 
Pharyngolaryngeal pain  1  0/106 (0.00%)  0/105 (0.00%)  1/107 (0.93%)  0/108 (0.00%)  1/106 (0.94%)  0/55 (0.00%) 
Rhinorrhoea  1  0/106 (0.00%)  1/105 (0.95%)  0/107 (0.00%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Sinus congestion  1  0/106 (0.00%)  1/105 (0.95%)  0/107 (0.00%)  0/108 (0.00%)  0/106 (0.00%)  1/55 (1.82%) 
Skin and subcutaneous tissue disorders             
Dermatitis  1  1/106 (0.94%)  0/105 (0.00%)  1/107 (0.93%)  0/108 (0.00%)  2/106 (1.89%)  0/55 (0.00%) 
Dermatitis atopic  1  0/106 (0.00%)  0/105 (0.00%)  0/107 (0.00%)  1/108 (0.93%)  0/106 (0.00%)  0/55 (0.00%) 
Dry skin  1  0/106 (0.00%)  0/105 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  1/106 (0.94%)  0/55 (0.00%) 
Erythema  1  1/106 (0.94%)  0/105 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Rash generalised  1  0/106 (0.00%)  1/105 (0.95%)  0/107 (0.00%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Skin exfoliation  1  0/106 (0.00%)  0/105 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  1/106 (0.94%)  0/55 (0.00%) 
Skin irritation  1  0/106 (0.00%)  0/105 (0.00%)  0/107 (0.00%)  0/108 (0.00%)  1/106 (0.94%)  0/55 (0.00%) 
Surgical and medical procedures             
Wisdom teeth removal  1  0/106 (0.00%)  1/105 (0.95%)  0/107 (0.00%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Vascular disorders             
Hypotension  1  0/106 (0.00%)  1/105 (0.95%)  1/107 (0.93%)  0/108 (0.00%)  0/106 (0.00%)  0/55 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.1
Certain Agreements
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
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00713609     History of Changes
Other Study ID Numbers: 114570
First Submitted: July 7, 2008
First Posted: July 11, 2008
Results First Submitted: November 12, 2016
Results First Posted: March 6, 2017
Last Update Posted: March 6, 2017