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Trial record 50 of 164 for:    acne AND Vehicle

A Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Common Facial 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: NCT01017120
Recruitment Status : Completed
First Posted : November 20, 2009
Results First Posted : July 6, 2012
Last Update Posted : May 18, 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: Tazarotene Foam
Drug: Vehicle Foam
Enrollment 742
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tazarotene Foam Vehicle Foam
Hide Arm/Group Description Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant. The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Period Title: Overall Study
Started 373 369
Completed 307 334
Not Completed 66 35
Reason Not Completed
Adverse Event             9             0
Lost to Follow-up             13             11
Lack of Efficacy             1             0
Withdrawal by Subject             39             21
Pregnancy             1             1
Did Not Meet Eligibility Criteria             1             0
Relocated Out of Town             0             2
Protocol Violation             1             0
Parent Unable to Provide Transportation             1             0
Arm/Group Title Tazarotene Foam Vehicle Foam Total
Hide Arm/Group Description Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant. The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant. Total of all reporting groups
Overall Number of Baseline Participants 373 369 742
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 373 participants 369 participants 742 participants
19.2  (6.5) 19.2  (6.8) 19.2  (6.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 373 participants 369 participants 742 participants
Female
197
  52.8%
185
  50.1%
382
  51.5%
Male
176
  47.2%
184
  49.9%
360
  48.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 373 participants 369 participants 742 participants
American Indian or Alaskan Native 2 2 4
Asian 28 21 49
Black 60 57 117
Native Hawaiian or Other Pacific Islander 0 4 4
White 278 280 558
Mixed Race 5 5 10
1.Primary Outcome
Title Absolute Change in Lesion Counts (LCs) From Baseline to Week 12
Hide Description LC: count of all inflammatory lesions (ILs, i.e., papules, pustules, and nodules) and non-inflammatory lesions (NILs, i.e., open and closed comedones) at Baseline and at Week 12. Total lesions (TLs) were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline.
Time Frame Baseline (Week 0/Day 1) and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Analysis Set: all randomized participants who were dispensed study product. Calculation was based on the last observation carried forward (LOCF) imputation method for missing data, in which missing final values of the outcome variable are replaced by the last known value before the participant was lost to follow up.
Arm/Group Title Tazarotene Foam Vehicle Foam
Hide Arm/Group Description:
Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Overall Number of Participants Analyzed 373 369
Mean (Standard Deviation)
Unit of Measure: lesion counts
ILs -17.8  (11.81) -14.7  (10.66)
NILs -25.6  (17.06) -18.2  (15.21)
TLs -43.4  (24.27) -32.9  (21.99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tazarotene Foam, Vehicle Foam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p-value indicates treatment differences between tazarotene foam and vehicle foam for ILs
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tazarotene Foam, Vehicle Foam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p-value indicates treatment differences between tazarotene foam and vehicle foam for NILs
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tazarotene Foam, Vehicle Foam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p-value indicates treatment differences between tazarotene foam and vehicle foam for TLs
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With a Minimum 2-grade (G) Improvement in the Investigator Static Global Assessment (ISGA) Score From Baseline at Week 12
Hide Description Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.
Time Frame Baseline (Week 0/Day 1) and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Tazarotene Foam Vehicle Foam
Hide Arm/Group Description:
Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Overall Number of Participants Analyzed 373 369
Measure Type: Number
Unit of Measure: participants
120 67
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tazarotene Foam, Vehicle Foam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants
Estimated Value 32.2
Confidence Interval (2-Sided) 95%
27.4 to 36.9
Estimation Comments The estimated value represents the percentage of participants receiving tazarotene foam with a minimum 2 G improvement in the ISGA score from Baseline at Week 12.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Foam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants
Estimated Value 18.2
Confidence Interval (2-Sided) 95%
14.2 to 22.1
Estimation Comments The estimated value represents the percentage of participants receiving vehicle foam with a minimum 2 G improvement in the ISGA score from Baseline at Week 12.
3.Primary Outcome
Title Number of Participants With an ISGA Score of 0 or 1 at Week 12
Hide Description Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set. Missing values were imputed using the LOCF method.
Arm/Group Title Tazarotene Foam Vehicle Foam
Hide Arm/Group Description:
Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Overall Number of Participants Analyzed 373 369
Measure Type: Number
Unit of Measure: participants
103 49
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tazarotene Foam, Vehicle Foam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants
Estimated Value 27.6
Confidence Interval (2-Sided) 95%
23.1 to 32.2
Estimation Comments The estimated value represents the percentage of participants receiving tazarotene foam with an ISGA score of 0 or 1 at Week 12.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Foam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants
Estimated Value 13.3
Confidence Interval (2-Sided) 95%
9.8 to 16.7
Estimation Comments The estimated value represents the percentage of participants receiving vehicle foam with an ISGA score of 0 or 1 at Week 12.
4.Secondary Outcome
Title Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12
Hide Description LC: count of all ILs (i.e., papules, pustules, and nodules) and NILs (i.e., open and closed comedones) at Baseline and at Week 12. TLs were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Percent change from Baseline in LC at Weeks 2, 4, 8, and12 was calculated as the (Week 2/4/8/12 value minus the baseline value divided by baseline value) x 100.
Time Frame Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set. The LOCF imputation method was used for missing data.
Arm/Group Title Tazarotene Foam Vehicle Foam
Hide Arm/Group Description:
Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Overall Number of Participants Analyzed 373 369
Mean (Standard Deviation)
Unit of Measure: percentage change
ILs, Week 2 -18.2  (26.12) -17.4  (26.16)
ILs, Week 4 -32.9  (30.18) -31.4  (29.13)
ILs, Week 8 -48.1  (30.99) -41.0  (28.77)
ILs, Week 12 -54.5  (32.79) -45.3  (30.72)
NILs, Week 2 -23.7  (25.82) -17.3  (25.03)
NILs, Week 4 -39.2  (27.30) -27.3  (29.28)
NILs, Week 8 -50.6  (27.35) -36.6  (27.81)
NILs, Week 12 -56.7  (28.84) -41.2  (31.09)
TLs, Week 2 -21.6  (20.44) -17.1  (20.38)
TLs, Week 4 -36.8  (23.43) -28.9  (23.35)
TLs, Week 8 -49.7  (24.65) -38.4  (24.33)
TLs, Week 12 -56.0  (26.76) -42.6  (26.80)
5.Secondary Outcome
Title Absolute Change From Baseline in LC at Weeks 2, 4, and 8
Hide Description LC: count of all ILs (i.e., papules, pustules, and nodules) and NILs (i.e., open and closed comedones) at Baseline and at Week 12. TLs were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Calculation was based on last observation carried forward (LOCF) imputation method for missing data.
Time Frame Baseline (Week 0/Day 1); Weeks 2, 4, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set. Calculation was based on the LOCF imputation method for missing data.
Arm/Group Title Tazarotene Foam Vehicle Foam
Hide Arm/Group Description:
Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Overall Number of Participants Analyzed 373 369
Mean (Standard Deviation)
Unit of Measure: lesion counts
ILs, Week 2 -5.9  (8.87) -5.6  (8.80)
ILs, Week 4 -10.7  (10.41) -10.2  (9.95)
ILs, Week 8 -15.7  (11.06) -13.3  (9.77)
NILs, Week 2 -10.7  (13.37) -7.7  (12.50)
NILs, Week 4 -17.3  (13.73) -11.8  (14.37)
NILs, Week 8 -22.6  (15.42) -16.5  (14.26)
TLs, Week 2 -16.6  (17.15) -13.3  (17.50)
TLs, Week 4 -28.0  (18.85) -22.0  (19.39)
TLs, Week 8 -38.3  (21.49) -29.7  (20.42)
6.Secondary Outcome
Title Time to a 50 Percent Reduction in Total Lesion Counts (TLC)
Hide Description Time to a 50 percent reduction in TLC (sum of ILs and NILs) was the time difference between Baseline and the time to 50 percent reduction in LC. Participants who did not have a >=50 percent reduction from Baseline in TLC during the study were censored at their last visit date.
Time Frame Baseline (Week 0/Day 1) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set: only those participants with a >=50 percent reduction from Baseline in TLC were evaluated.
Arm/Group Title Tazarotene Foam Vehicle Foam
Hide Arm/Group Description:
Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Overall Number of Participants Analyzed 265 194
Median (95% Confidence Interval)
Unit of Measure: days
57
(56 to 57)
85
(65 to 85)
7.Secondary Outcome
Title Number of Participants With a Minimum 2 G Improvement in ISGA Score at Weeks 2, 4, and 8
Hide Description Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.
Time Frame Baseline (Week 0/Day 1); Weeks 2, 4, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Tazarotene Foam Vehicle Foam
Hide Arm/Group Description:
Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Overall Number of Participants Analyzed 373 369
Measure Type: Number
Unit of Measure: participants
Week 2 8 4
Week 4 33 16
Week 8 69 35
8.Secondary Outcome
Title Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8
Hide Description Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.
Time Frame Weeks 2, 4, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set. Missing values were imputed using the LOCF method.
Arm/Group Title Tazarotene Foam Vehicle Foam
Hide Arm/Group Description:
Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Overall Number of Participants Analyzed 373 369
Measure Type: Number
Unit of Measure: participants
Week 2 5 2
Week 4 26 12
Week 8 56 26
9.Secondary Outcome
Title Number of Participants With a Subject’s Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12
Hide Description An SGA of the facial skin, excluding the scalp, was performed by participants using a rating scale of 0 to 4: 0=face is basically free of acne, with only an occasional blackhead (Bh) and/or whitehead (Wh); 1=face has several Bhs and/or Whs and small pimples (P), but there are no tender deep-seated bumps or cysts (DSBCs); 2=face has several to many Bhs and/or Whs and small- to medium-sized P, and may have one DSBC; 3=face has many Bhs and/or Whs, many medium- to large-sized P, and perhaps a few DSBCs; 4=face has Bhs and/or Whs, and several to many medium- to large-sized Ps and DSBCs dominate.
Time Frame Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Tazarotene Foam Vehicle Foam
Hide Arm/Group Description:
Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Overall Number of Participants Analyzed 373 369
Measure Type: Number
Unit of Measure: participants
Week 2 83 93
Week 4 136 114
Week 8 171 125
Week 12 213 153
10.Secondary Outcome
Title Number of Participants With a 2-G Improvement in ISGA Score and an ISGA Score of 0 or 1 at Weeks 2, 4, 8, and 12
Hide Description Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.
Time Frame Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Tazarotene Foam Vehicle Foam
Hide Arm/Group Description:
Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Overall Number of Participants Analyzed 373 369
Measure Type: Number
Unit of Measure: participants
Week 2 5 2
Week 4 26 12
Week 8 56 26
Week 12 103 49
11.Secondary Outcome
Title Absolute Change in Papule Count From Baseline at Weeks 2, 4, 8, and 12
Hide Description A papule is a circumscribed, solid elevation of the skin with no visible fluid. Change from basline in papule count at Weeks 2, 4, 8, and 12 was calculated as the papule count at Week 2/4/8/12 minus the papule count at Baseline.
Time Frame Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Tazarotene Foam Vehicle Foam
Hide Arm/Group Description:
Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Overall Number of Participants Analyzed 373 369
Mean (Standard Deviation)
Unit of Measure: papule count
Week 2 -4.3  (7.23) -4.3  (8.28)
Week 4 -8.3  (8.76) -7.8  (9.27)
Week 8 -12.0  (9.55) -10.4  (9.13)
Week 12 -13.5  (10.06) -11.5  (10.00)
12.Secondary Outcome
Title Absolute Change in Pustule Count From Baseline at Weeks 2, 4, 8, and 12
Hide Description A pustule is a small elevation of the skin containing cloudy or purulent material usually consisting of necrotic inflammatory cells. Change from basline in pustule count at Weeks 2, 4, 8, and 12 was calculated as the pustule count at Week 2/4/8/12 minus the pustule count at Baseline.
Time Frame Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Tazarotene Foam Vehicle Foam
Hide Arm/Group Description:
Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Overall Number of Participants Analyzed 373 369
Mean (Standard Deviation)
Unit of Measure: pustule count
Week 2 -1.5  (5.70) -1.3  (4.46)
Week 4 -2.4  (6.21) -2.4  (5.04)
Week 8 -3.7  (6.08) -2.9  (5.14)
Week 12 -4.2  (6.42) -3.2  (5.68)
13.Secondary Outcome
Title Absolute Change in Nodule Count From Baseline at Weeks 2, 4, 8, and 12
Hide Description A nodule is a slightly elevated lesion on or in the skin. Change from basline in nodule count at Weeks 2, 4, 8, and 12 was calculated as the nodule count at Week 2/4/8/12 value (s) minus the nodule count at Baseline.
Time Frame Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
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ITT Analysis Set
Arm/Group Title Tazarotene Foam Vehicle Foam
Hide Arm/Group Description:
Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Overall Number of Participants Analyzed 373 369
Mean (Standard Deviation)
Unit of Measure: nodule count
Week 2 -0.0  (0.35) 0.0  (0.72)
Week 4 -0.0  (0.40) 0.0  (0.80)
Week 8 -0.0  (0.40) 0.1  (0.83)
Week 12 -0.0  (0.35) 0.0  (0.78)
14.Secondary Outcome
Title Absolute Change in Open Comedone Count From Baseline at Weeks 2, 4, 8, and 12
Hide Description An open comedone is a yellow or blackish bump or plug on the skin. Change from Baseline in open comedone count at Weeks 2, 4, 8, and 12 was calculated as the open comedone count at Week 2/4/8/12 minus the open comedone count at Baseline.
Time Frame Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
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Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Tazarotene Foam Vehicle Foam
Hide Arm/Group Description:
Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Overall Number of Participants Analyzed 373 369
Mean (Standard Deviation)
Unit of Measure: open comedone count
Week 2 -3.5  (8.49) -3.1  (8.20)
Week 4 -5.8  (9.19) -4.2  (9.06)
Week 8 -7.3  (10.13) -5.8  (9.46)
Week 12 -8.4  (10.90) -6.9  (9.56)
15.Secondary Outcome
Title Absolute Change in Closed Comedone Count From Baseline at Weeks 2, 4, 8, and 12
Hide Description A closed comedone is a whitehead. Change from basline in closed comedone count at Weeks 2, 4, 8, and 12 was calculated as the closed comedone count at Week 2/4/8/12 minus the closed comedone count at Baseline.
Time Frame Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Tazarotene Foam Vehicle Foam
Hide Arm/Group Description:
Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Overall Number of Participants Analyzed 373 369
Mean (Standard Deviation)
Unit of Measure: closed comedone count
Week 2 -7.3  (10.84) -4.5  (10.52)
Week 4 -11.5  (12.56) -7.6  (11.55)
Week 8 -15.3  (14.10) -10.7  (11.98)
Week 12 -17.2  (14.66) -11.4  (13.96)
16.Secondary Outcome
Title Change in Dermatology Life Quality Index (DLQI) Score From Baseline at Weeks 2, 4, 8, and 12 in Participants 17 Years of Age or Older
Hide Description The DLQI was used to measure how much the participants’ skin problem had affected their life over the last week. The DLQI total score ranges from 0 to 30: 0-1=no effect at all on the participant’s life; 2-5=small effect on the participant’s life; 6-10=moderate effect on the participant’s life; 11-20=very large effect on the participant’s life; 21-30=extremely large effect on the participant’s life. A lower score on the DLQI indicates increased quality of life; therefore, negative changes from Baseline indicate improvements.
Time Frame Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
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Hide Analysis Population Description
ITT Analysis Set: only those participants 17 years of age or older and whose DLQI scores were calculated at baseline and at Weeks 2, 4, 8, or 12 were evaluated for change in DLQI score at respective week.
Arm/Group Title Tazarotene Foam Vehicle Foam
Hide Arm/Group Description:
Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Overall Number of Participants Analyzed 175 178
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 2, n=175, 178 -1.3  (5.28) -1.9  (3.68)
Week 4, n=170, 184 -2.4  (4.80) -2.7  (3.92)
Week 8, n=163, 176 -2.9  (5.14) -3.1  (4.64)
Week 12, n=162, 176 -3.7  (5.33) -3.2  (4.98)
17.Secondary Outcome
Title Change in Children’s Dermatology Life Quality Index (CDLQI) From Baseline at Week 2, 4, 8 and 12 in Participant's With 16 Years Old or Younger
Hide Description The CDLQI was used to measure how much the participants’ skin problem had affected their life over the last week. The CDLQI total score ranges from 0 to 30: 0-1=no effect at all on the participant’s life; 2-6=small effect on the participant’s life; 7-12=moderate effect on the participant’s life; 13-18=very large effect on the participant’s life; 19-30=extremely large effect on the participant’s life. A lower score on the CDLQI indicates increased quality of life; therefore, negative changes from Baseline indicate improvements.
Time Frame Baseline (Week 0/Day 1); Week 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set: only those participants 16 years of age or younger and whose CDLQI scores were calculated at Baseline and at Weeks 2, 4, 8, or 12 were evaluated for change in DLQI score at respective week.
Arm/Group Title Tazarotene Foam Vehicle Foam
Hide Arm/Group Description:
Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Overall Number of Participants Analyzed 153 163
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 2, n=153, 163 1.3  (4.01) -1.5  (2.96)
Week 4, n=143, 158 -0.9  (3.30) -1.9  (3.33)
Week 8, n=137, 158 -1.6  (3.19) -1.9  (3.13)
Week 12, n=137, 153 -1.6  (4.06) -2.0  (3.58)
18.Secondary Outcome
Title Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator
Hide Description Erythema is a skin condition characterized by redness or rash. Local tolerability assessments were performed by the Investigator at each study visit and were graded based on severity as G0 to G4: G0=absent (no redness); G1=slight (faint red or pink coloration, barely perceptible); G2=mild (light red or pink coloration); G3=moderate (medium red coloration); G4=severe (beet red coloration). Maximum During Treatment is defined as the maximum severity of erythema reported at any time during treatment.
Time Frame Baseline (Week 0/Day 1) to Week 12
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Hide Analysis Population Description
All Randomized Participants: all participants who were randomized in the study
Arm/Group Title Tazarotene Foam Vehicle Foam
Hide Arm/Group Description:
Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Overall Number of Participants Analyzed 373 369
Measure Type: Number
Unit of Measure: participants
Baseline, G0 247 234
Baseline, G1 65 75
Baseline, G2 21 20
Baseline, G3 40 40
Baseline, G4 0 0
Baseline, Missing G 0 0
Maximum During Treatment (MDT), G0 76 141
MDT, G1 117 132
MDT, G2 111 51
MDT, G3 56 37
MDT, G4 2 0
MDT, Missing G 11 8
Week 12, G0 175 218
Week 12, G1 93 73
Week 12, G2 30 21
Week 12, G3 9 19
Week 12, G4 0 0
Week 12, Missing G 66 38
19.Secondary Outcome
Title Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator
Hide Description Dryness=skin epidermis that lacks moisture/sebum. Local tolerability assessments were performed by the Investigator at each study visit and were graded based on severity as G0 to G4. G0=absent (none); G1=slight (barely perceptible dryness with no flakes or fissure formation); G2=mild (easily perceptible dryness with no flakes or fissure formation); G3=moderate (easily noted dryness and flakes but no fissure formation); G4=severe (easily noted dryness with flakes and fissure formation). Maximum During Treatment is defined as the maximum severity of dryness reported at any time during treatment.
Time Frame Baseline (Week 0/Day 1) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Participants
Arm/Group Title Tazarotene Foam Vehicle Foam
Hide Arm/Group Description:
Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Overall Number of Participants Analyzed 373 369
Measure Type: Number
Unit of Measure: participants
Baseline, G0 316 312
Baseline, G1 39 43
Baseline, G2 13 8
Baseline, G3 5 6
Baseline, G4 0 0
Baseline, Missing G 0 0
MDT, G0 73 193
MDT, G1 136 124
MDT, G2 87 36
MDT, G3 61 7
MDT, G4 5 1
MDT, Missing G 11 8
Week 12, G0 219 294
Week 12, G1 73 35
Week 12, G2 14 2
Week 12, G3 1 0
Week 12, G4 0 0
Week 12, Missing G 66 38
20.Secondary Outcome
Title Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator
Hide Description Peeling skin: damage to and loss of the upper layer of skin (epidermis). Local tolerability assessments for peeling were performed by the Investigator at each study visit and were graded based on severity as G0 to G4: G0=absent (no peeling); G1=slight (mild localized peeling); G2=mild (mild and diffuse peeling); G3=moderate (moderate and diffuse peeling); G4=severe (moderate to prominent, dense peeling). Maximum During Treatment is defined as the maximum severity of peeling reported at any time during treatment.
Time Frame Baseline (Week 0/Day 1) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Participants
Arm/Group Title Tazarotene Foam Vehicle Foam
Hide Arm/Group Description:
Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Overall Number of Participants Analyzed 373 369
Measure Type: Number
Unit of Measure: participants
Baseline, G0 342 339
Baseline, G1 22 18
Baseline, G2 7 6
Baseline, G3 2 6
Baseline, G4 0 0
Baseline, Missing G 0 0
MDT, G0 108 255
MDT, G1 152 85
MDT, G2 69 18
MDT, G3 28 3
MDT, G4 5 0
MDT, Missing G 11 8
Week 12, G0 251 313
Week 12, G1 48 17
Week 12, G2 7 1
Week 12, G3 1 0
Week 12, G4 0 0
Week 12, Missing G 66 38
21.Secondary Outcome
Title Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants
Hide Description Itching is a sensation that causes the desire or reflex to scratch. Local tolerability assessments for itching were performed by the participant at each study visit and were graded based on severity as G0 to G3. G0=none; G1=slight; G2=moderate; G3=strong. Maximum During Treatment is defined as the maximum severity of itching reported at any time during treatment.
Time Frame Baseline (Week 0/Day 1) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Participants
Arm/Group Title Tazarotene Foam Vehicle Foam
Hide Arm/Group Description:
Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Overall Number of Participants Analyzed 373 369
Measure Type: Number
Unit of Measure: participants
Baseline, G0 205 209
Baseline, G1 133 131
Baseline, G2 31 27
Baseline, G3 4 2
Baseline, Missing G 0 0
MDT, G0 57 145
MDT, G1 169 155
MDT, G2 96 51
MDT, G3 39 10
MDT, Missing G 12 8
Week 12, G0 176 224
Week 12, G1 105 88
Week 12, G2 22 13
Week 12, G3 4 6
Week 12, Missing G 66 38
22.Secondary Outcome
Title Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants
Hide Description Burning/stinging is a pain and burning sensation. Local tolerability assessments were performed by the participant at each study visit based on severity as G0 to G3: G0=none; G1=slight; G2=moderate; G3=strong. Maximum During Treatment is defined as the maximum severity of burning/stinging reported at any time during treatment.
Time Frame Baseline (Week 0/Day 1) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Participants
Arm/Group Title Tazarotene Foam Vehicle Foam
Hide Arm/Group Description:
Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Overall Number of Participants Analyzed 373 369
Measure Type: Number
Unit of Measure: participants
Baseline, G0 299 290
Baseline, G1 60 62
Baseline, G2 12 16
Baseline, G3 2 1
Baseline, Missing G 0 0
MDT, G0 57 109
MDT, G1 169 181
MDT, G2 105 55
MDT, G3 104 16
MDT, Missing G 12 8
Week 12, G0 168 223
Week 12, G1 97 86
Week 12, G2 34 15
Week 12, G3 8 7
Week 12, Missing G 66 38
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tazarotene Foam Vehicle Foam
Hide Arm/Group Description Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant. The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
All-Cause Mortality
Tazarotene Foam Vehicle Foam
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tazarotene Foam Vehicle Foam
Affected / at Risk (%) Affected / at Risk (%)
Total   1/373 (0.27%)   0/369 (0.00%) 
Nervous system disorders     
Convulsion  1  1/373 (0.27%)  0/369 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tazarotene Foam Vehicle Foam
Affected / at Risk (%) Affected / at Risk (%)
Total   69/373 (18.50%)   10/369 (2.71%) 
General disorders     
Application site dryness  1  28/373 (7.51%)  6/369 (1.63%) 
Application Site Irritation  1  41/373 (10.99%)  4/369 (1.08%) 
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: NCT01017120     History of Changes
Other Study ID Numbers: 114576
First Submitted: November 19, 2009
First Posted: November 20, 2009
Results First Submitted: May 31, 2012
Results First Posted: July 6, 2012
Last Update Posted: May 18, 2017