Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 4, Single-Blind, Randomized, Study to Compare the Tolerability and Efficacy of 0.1% Tazorac Cream When Used in Combination With Either Duac Gel or Acanya Gel for the Treatment of Facial Acne Vulgaris (C0000-411)

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: NCT01016977
Recruitment Status : Completed
First Posted : November 20, 2009
Results First Posted : February 23, 2012
Last Update Posted : January 30, 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: Single (Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene
Drug: clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tazorac Cream/Duac Gel Tazorac Cream/Acanya Gel
Hide Arm/Group Description Tazorac (tazarotene 0.1%) cream in evening (PM) and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in morning (AM) daily for topical administration on face Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
Period Title: Overall Study
Started 20 20
Completed 17 18
Not Completed 3 2
Reason Not Completed
Lost to Follow-up             1             0
Withdrawal by Subject             2             2
Arm/Group Title Tazorac Cream/Duac Gel Tazorac Cream/Acanya Gel Total
Hide Arm/Group Description Tazorac (tazarotene 0.1%) cream in evening (PM) and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in morning (AM) daily for topical administration on face Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
21.2  (9.0) 22.6  (7.8) 21.9  (8.3)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
13
  65.0%
9
  45.0%
22
  55.0%
Male
7
  35.0%
11
  55.0%
18
  45.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Asian 8 15 23
Black 1 1 2
White 9 4 13
Biracial, India, Black, and Phillipino 1 0 1
Multiracial (Black, White) 1 0 1
1.Primary Outcome
Title Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12
Hide Description Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Erythema (redness of the skin, due to increased blood flow in the capillaries in the lower layers of theh skin) was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense.
Time Frame Baseline and Weeks 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all randomized participants who received study product. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.
Arm/Group Title Tazorac Cream/Duac Gel Tazorac Cream/Acanya Gel
Hide Arm/Group Description:
Tazorac (tazarotene 0.1%) cream in evening (PM) and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in morning (AM) daily for topical administration on face
Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1, n=19, 17 0.79  (1.03) 0.76  (0.75)
Week 2, n=20, 19 0.60  (0.82) 0.47  (0.70)
Week 4, n=20, 20 0.50  (0.89) 0.55  (0.76)
Week 8, n=20, 20 0.20  (0.62) 0.20  (0.52)
Week 12, n=20, 20 0.25  (0.64) 0.10  (0.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9597
Comments Week 1
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5538
Comments Week 2
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6315
Comments Week 4
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5655
Comments Week 8
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7917
Comments Week 12
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12
Hide Description Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Dryness was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense.
Time Frame Baseline and Weeks 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.
Arm/Group Title Tazorac Cream/Duac Gel Tazorac Cream/Acanya Gel
Hide Arm/Group Description:
Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1, n=19, 17 1.11  (1.05) 1.18  (0.81)
Week 2, n=20, 19 1.15  (0.81) 0.84  (0.96)
Week 4, n=20, 20 0.65  (0.75) 0.55  (0.83)
Week 8, n=20, 20 0.50  (0.95) 0.15  (0.59)
Week 12, n=20, 20 0.20  (0.70) -0.05  (0.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5961
Comments Week 1
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2293
Comments Week 2
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9852
Comments Week 4
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5538
Comments Week 8
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6540
Comments Week 12
Method ANCOVA
Comments [Not Specified]
3.Primary Outcome
Title Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12
Hide Description Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Peeling was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense.
Time Frame Baseline and Weeks 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.
Arm/Group Title Tazorac Cream/Duac Gel Tazorac Cream/Acanya Gel
Hide Arm/Group Description:
Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
Tazorac (tazarotene 0.1%) cream at PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1, n=19, 17 1.11  (1.05) 1.06  (0.83)
Week 2, n=20, 19 1.05  (0.83) 0.79  (0.98)
Week 4, n=20, 20 0.60  (0.75) 0.55  (0.83)
Week 8, n=20, 20 0.50  (0.95) 0.10  (0.55)
Week 12, n=20, 20 0.20  (0.70) -0.05  (0.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8545
Comments Week 1
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2895
Comments Week 2
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8234
Comments Week 4
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3644
Comments Week 8
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6540
Comments Week 12
Method ANCOVA
Comments [Not Specified]
4.Primary Outcome
Title Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12
Hide Description Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Burning/stinging was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities.
Time Frame Baseline and Weeks 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.
Arm/Group Title Tazorac Cream/Duac Gel Tazorac Cream/Acanya Gel
Hide Arm/Group Description:
Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1, n=19, 17 1.58  (1.87) 1.65  (1.69)
Week 2, n=20, 19 0.70  (1.59) 0.84  (1.07)
Week 4, n=20, 20 1.25  (1.92) 0.55  (0.76)
Week 8, n=20, 20 0.60  (1.27) 0.45  (0.69)
Week 12, n=20, 20 0.50  (1.40) 0.40  (0.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7546
Comments Week 1
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7705
Comments Week 2
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0259
Comments Week 4
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9252
Comments Week 8
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2927
Comments Week 12
Method ANCOVA
Comments [Not Specified]
5.Primary Outcome
Title Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12
Hide Description Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 6, 8, and 12 minus the value at baseline. Itching was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities.
Time Frame Baseline and Weeks 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.
Arm/Group Title Tazorac Cream/Duac Gel Tazorac Cream/Acanya Gel
Hide Arm/Group Description:
Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
Tazorac (tazarotene 0.1%) cream at PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1, n=19, 17 0.68  (1.57) 0.76  (1.64)
Week 2, n=20, 19 0.10  (0.79) 0.84  (1.38)
Week 4, n=20, 20 0.20  (1.20) 0.65  (1.18)
Week 8, n=20, 20 -0.05  (1.15) 0.30  (0.80)
Week 12, n=20, 20 0.35  (1.42) 0.45  (1.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4010
Comments Week 1
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0963
Comments Week 2
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9291
Comments Week 4
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5523
Comments Week 8
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2556
Comments Week 12
Method ANCOVA
Comments [Not Specified]
6.Primary Outcome
Title Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12
Hide Description Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Oiliness was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities.
Time Frame Baseline and Weeks 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.
Arm/Group Title Tazorac Cream/Duac Gel Tazorac Cream/Acanya Gel
Hide Arm/Group Description:
Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
Tazorac (tazarotene 0.1%) cream at PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1, n=19, 17 -1.00  (1.60) -1.29  (1.40)
Week 2, n=20, 19 -0.95  (1.61) -1.05  (1.35)
Week 4, n=20, 20 -0.85  (1.87) -0.55  (1.85)
Week 8, n=20, 20 -0.80  (1.79) -1.05  (1.39)
Week 12, n=20, 20 -0.35  (1.84) -0.75  (1.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4037
Comments Week 1
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8662
Comments Week 2
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5951
Comments Week 4
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2349
Comments Week 8
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3461
Comments Week 12
Method ANCOVA
Comments [Not Specified]
7.Primary Outcome
Title Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12
Hide Description Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Skin comfort was assessed by participants based on 5-point scale: +2, very comfortable; +1, comfortable; 0, neutral; -1, somewhat uncomfortable; or -2, uncomfortable.
Time Frame Baseline and Weeks 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.
Arm/Group Title Tazorac Cream/Duac Gel Tazorac Cream/Acanya Gel
Hide Arm/Group Description:
Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1, n=19, 17 -0.37  (1.54) -0.29  (0.92)
Week 2, n=20, 19 0.25  (1.45) 0.05  (0.91)
Week 4, n=20, 20 0.05  (1.23) -0.10  (0.85)
Week 8, n=20, 20 0.30  (1.17) 0.10  (0.85)
Week 12, n=20, 20 0.45  (1.39) 0.60  (0.99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7250
Comments Week 1
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9743
Comments Week 2
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9816
Comments Week 4
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8809
Comments Week 8
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tazorac Cream/Duac Gel, Tazorac Cream/Acanya Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1679
Comments Week 12
Method ANCOVA
Comments [Not Specified]
8.Secondary Outcome
Title Number of Participants With at Least a Two-grade Improvement in ISGA Score From Baseline to Week 12
Hide Description The investigator conducted the overall assessment of the participant’s facial acne vulgaris based on the Investigator's Static Global Assessment Scale (ISGA). The ISGA is a 6-point scale: 0, clear skin with no acne vulgaris; 1, almost clear skin; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Tazorac Cream/Duac Gel Tazorac Cream/Acanya Gel
Hide Arm/Group Description:
Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: participants
7 10
9.Secondary Outcome
Title Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12
Hide Description Inflammation is defined as a localized protective reaction of tissue to irritation, injury, or infection, characterized by pain, redness, swelling, and sometimes loss of function. The investigator counted inflammatory (papules, pustules, and nodules) and non-inflammatory (open and closed comedones) lesions on a participant's face at each study visit. The face is defined as the hairline edge to the mandibular line and should include the forehead, cheeks, and chin. W, Week.
Time Frame Baseline and Weeks 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Tazorac Cream/Duac Gel Tazorac Cream/Acanya Gel
Hide Arm/Group Description:
Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: lesions
W1, Inflammatory lesions, n=19, 17 -6.6  (5.3) -5.9  (6.1)
W2, Inflammatory lesions, n=20, 19 -8.8  (8.7) -8.1  (6.3)
W4, Inflammatory lesions, n=20, 20 -13.0  (6.3) -9.6  (9.2)
W8, Inflammatory lesions, n=20, 20 -14.9  (7.2) -16.3  (5.7)
W12, Inflammatory lesions, n=20, 20 -18.0  (6.6) -13.4  (13.6)
W1, Non-inflammatory lesions, n=19, 17 -3.2  (11.2) -7.6  (7.1)
W2, Non-inflammatory lesions, n=20, 19 -17.9  (11.4) -15.1  (11.4)
W4, Non-inflammatory lesions, n=20, 20 -23.6  (13.6) -26.6  (13.2)
W8, Non-inflammatory lesions, n=20, 20 -28.9  (19.1) -33.1  (17.3)
W12, Non-inflammatory lesions, n=20, 20 -32.6  (19.4) -37.8  (21.4)
10.Secondary Outcome
Title Mean Change From Baseline in Total Lesion Count at Weeks 1, 2, 4, 8, and 12
Hide Description The investigator will count inflammatory (papules, pustules, and nodules) and non-inflammatory (open and closed comedones) lesions on the participant's face at each study visit. The face is defined as the hairline edge to the mandibular line and should include the forehead, cheeks, and chin.
Time Frame Baseline and Weeks 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Tazorac Cream/Duac Gel Tazorac Cream/Acanya Gel
Hide Arm/Group Description:
Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: lesions
Week 1, n=19, 17 -9.8  (14.0) -13.5  (9.4)
Week 2, n=20, 19 -26.6  (15.3) -23.1  (14.5)
Week 4, n=20, 20 -36.6  (15.4) -36.2  (15.4)
Week 8, n=20, 20 -43.7  (23.5) -49.4  (20.2)
Week 12, n=20, 20 -50.6  (23.1) -51.1  (27.8)
11.Secondary Outcome
Title Mean Change From Baseline for the Global Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12
Hide Description Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Global Score is the sum of the 30 question scores; total score ranges from 30 to 150.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants with missing baseline values were not included in this analysis. No sunscreen or moisturizer data were collected; thus, there was no analysis of these data.
Arm/Group Title Tazorac Cream/Duac Gel Tazorac Cream/Acanya Gel
Hide Arm/Group Description:
Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.1  (11.6) -3.7  (8.4)
12.Secondary Outcome
Title Mean Change From Baseline for the Symptomatic Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12
Hide Description Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Symptomatic Score is the sum of 7 question scores; total score ranges from 7 to 35.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants with missing baseline values were not included in this analysis. No sunscreen or moisturizer data were collected; thus, there was no analysis of these data.
Arm/Group Title Tazorac Cream/Duac Gel Tazorac Cream/Acanya Gel
Hide Arm/Group Description:
Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
-8.7  (15.7) -1.4  (13.5)
13.Secondary Outcome
Title Mean Change From Baseline for the Emotional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12
Hide Description Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Emotional Score is the sum of 10 question scores; total score ranges from 10 to 50.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants with missing baseline values were not included in this analysis. No sunscreen or moisturizer data were collected; thus, there was no analysis of these data.
Arm/Group Title Tazorac Cream/Duac Gel Tazorac Cream/Acanya Gel
Hide Arm/Group Description:
Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
-11.2  (11.8) -7.1  (8.9)
14.Secondary Outcome
Title Mean Change From Baseline for the Functional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12
Hide Description Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Functional Score is the sum of 12 question scores; total score ranges from 12 to 60.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants with missing baseline values were not included in this analysis. No sunscreen or moisturizer data were collected; thus, there was no analysis of these data.
Arm/Group Title Tazorac Cream/Duac Gel Tazorac Cream/Acanya Gel
Hide Arm/Group Description:
Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.1  (11.6) -3.7  (8.4)
15.Secondary Outcome
Title Overall Satisfaction With Study Product at Week 12
Hide Description Overall satisfaction with the study product was assessed from a participant's answer to the following question on the product acceptability and preference questionnaire at the end of study (i.e., Week 12): "What is your overall satisfaction with the study product." Participants assessed overall satisfaction with the study product in the morning and evening, based on a 6-point scale: 1, very satisfied; 2, satisfied; 3, neutral (no opinion); 4, unsatisfied; 5, very unsatisfied.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Tazorac Cream/Duac Gel Tazorac Cream/Acanya Gel
Hide Arm/Group Description:
Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Morning 1.76  (1.15) 1.75  (0.72)
Evening 1.59  (1.00) 1.70  (0.92)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tazorac Cream/Duac Gel Tazorac Cream/Acanya Gel
Hide Arm/Group Description Tazorac (tazarotene 0.1%) cream in evening (PM) and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in morning (AM) daily for topical administration on face Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
All-Cause Mortality
Tazorac Cream/Duac Gel Tazorac Cream/Acanya Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tazorac Cream/Duac Gel Tazorac Cream/Acanya Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tazorac Cream/Duac Gel Tazorac Cream/Acanya Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   11/20 (55.00%)   7/20 (35.00%) 
General disorders     
Application Site Erythema  1  1/20 (5.00%)  0/20 (0.00%) 
Application Site Irritation  1  1/20 (5.00%)  0/20 (0.00%) 
Pyrexia  1  1/20 (5.00%)  0/20 (0.00%) 
Infections and infestations     
Nasopharyngitis  1  6/20 (30.00%)  6/20 (30.00%) 
Bacterial Infection  1  1/20 (5.00%)  0/20 (0.00%) 
Influenza  1  1/20 (5.00%)  0/20 (0.00%) 
Viral Infection  1  0/20 (0.00%)  1/20 (5.00%) 
Reproductive system and breast disorders     
Dysmenorrhea  1  0/20 (0.00%)  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal Pain  1  2/20 (10.00%)  0/20 (0.00%) 
Cough  1  1/20 (5.00%)  0/20 (0.00%) 
Nasal Congestion  1  0/20 (0.00%)  1/20 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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
Layout table for additonal information
Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT01016977     History of Changes
Obsolete Identifiers: NCT01334970
Other Study ID Numbers: 114566
First Submitted: November 19, 2009
First Posted: November 20, 2009
Results First Submitted: January 19, 2012
Results First Posted: February 23, 2012
Last Update Posted: January 30, 2017