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Trial record 57 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 - W0260-301

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ClinicalTrials.gov Identifier: NCT01017146
Recruitment Status : Completed
First Posted : November 20, 2009
Results First Posted : July 6, 2012
Last Update Posted : January 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 744
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 372 372
Completed 306 333
Not Completed 66 39
Reason Not Completed
Adverse Event             11             1
Lost to Follow-up             14             14
Noncompliance with Study Product             1             1
Withdrawal by Subject             32             16
Relocation             0             4
Pregnancy             2             1
Protocol Violation             2             0
Took Excluded Medication             2             0
Did Not Meet Eligibility Criteria             1             2
Change in Work Situation             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 371 372 743
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Years Number Analyzed 371 participants 372 participants 743 participants
18.2  (5.7) 18.6  (6.4) 18.4  (6.1)
[1]
Measure Description: Baseline Characteristics were collected in members of the Intent-to-Treat (ITT) Analysis Set, consisting of all randomized participants who were dispensed study product. One participant was randomized to the tazarotene foam group, but discontinued due to pregnancy and did not receive study product.
Gender   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 371 participants 372 participants 743 participants
Female
182
  49.1%
192
  51.6%
374
  50.3%
Male
189
  50.9%
180
  48.4%
369
  49.7%
[1]
Measure Description: Baseline Characteristics were collected in members of the Intent-to-Treat (ITT) Analysis Set, consisting of all randomized participants who were dispensed study product. One participant was randomized to the tazarotene foam group, but discontinued due to pregnancy and did not receive study product.
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 371 participants 372 participants 743 participants
American Indian or Alaska Native 12 3 15
Asian 11 4 15
Black 53 50 103
Native Hawaiian or Other Pacific Islander 0 1 1
White 285 307 592
Mixed Race 10 7 17
[1]
Measure Description: Baseline Characteristics were collected in members of the Intent-to-Treat (ITT) Analysis Set, consisting of all randomized participants who were dispensed study product. One participant was randomized to the tazarotene foam group, but discontinued due to pregnancy and did not receive study product.
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 371 372
Mean (Standard Deviation)
Unit of Measure: lesion counts
ILs -18.0  (11.01) -14.1  (12.37)
NILs -27.9  (21.65) -16.7  (21.72)
TLs -45.8  (27.89) -30.8  (26.68)
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 371 372
Measure Type: Number
Unit of Measure: participants
132 89
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 35.6
Confidence Interval (2-Sided) 95%
30.7 to 40.5
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 23.9
Confidence Interval (2-Sided) 95%
19.6 to 28.3
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 371 372
Measure Type: Number
Unit of Measure: participants
107 60
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 28.8
Confidence Interval (2-Sided) 95%
24.2 to 33.5
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 16.1
Confidence Interval (2-Sided) 95%
12.4 to 19.9
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 371 372
Mean (Standard Deviation)
Unit of Measure: percent change
ILs, Week 2 -18.2  (35.84) -20.9  (33.64)
ILs, Week 4 -33.0  (32.75) -24.8  (34.42)
ILs, Week 8 -50.1  (31.53) -42.1  (38.62)
ILs, Week 12 -57.5  (33.39) -45.2  (38.64)
NILs, Week 2 -24.5  (26.21) -16.6  (28.64)
NILs, Week 4 -36.6  (28.59) -25.0  (32.45)
NILs, Week 8 -48.7  (29.20) -30.6  (36.64)
NILs, Week 12 -55.1  (30.88) -34.3  (42.56)
TLs, Week 2 -22.5  (23.39) -18.8  (22.21)
TLs, Week 4 -35.3  (25.41) -29.3  (26.98)
TLs, Week 8 -49.5  (26.2) -35.6  (31.16)
TLs, Week 12 -56.3  (28.52) -39.0  (34.40)
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 371 372
Mean (Standard Deviation)
Unit of Measure: lesion counts
ILs, Week 2 -5.5  (11.54) -6.5  (11.98)
ILs, Week 4 -10.1  (10.44) -10.9  (11.74)
ILs, Week 8 -15.6  (10.40) -13.2  (12.71)
NILs, Week 2 -12.6  (15.72) -8.6  (16.22)
NILs, Week 4 -18.2  (17.70) -12.2  (18.41)
NILs, Week 8 -24.6  (19.64) -14.8  (21.63)
TLs, Week 2 -18.1  (20.22) -15.1  (18.80)
TLs, Week 4 -28.3  (22.77) -23.1  (23.30)
TLs, Week 8 -40.1  (24.67) -27.9  (28.09)
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 273 197
Median (95% Confidence Interval)
Unit of Measure: days
57
(57 to 58)
85
(80 to 86)
7.Secondary Outcome
Title Number of Participants With a Minimum 2-grade 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 371 372
Measure Type: Number
Unit of Measure: participants
Week 2 10 11
Week 4 23 29
Week 8 64 44
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 371 372
Measure Type: Number
Unit of Measure: participants
Week 2 4 1
Week 4 12 7
Week 8 40 22
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 371 372
Measure Type: Number
Unit of Measure: participants
Week 2 104 1
Week 4 143 130
Week 8 187 165
Week 12 220 180
10.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
Hide Outcome Measure Data
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 the 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 171 165
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Week 2, n=171,165 -0.1  (4.98) -2.1  (3.68)
Week 4, n=166, 167 -1.9  (4.60) -2.5  (3.85)
Week 8, n=160, 155 -2.9  (4.86) -2.7  (4.40)
Week 12, n=154, 155 -3.6  (5.22) -3.1  (4.31)
11.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); Weeks 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 the 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 162 179
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 2, n=162,179 1.1  (4.16) -1.4  (3.21)
Week 4, n=153, 180 -0.6  (3.45) -1.4  (3.23)
Week 8, n=148, 171 -1.2  (3.53) -1.9  (3.11)
Week 12, n=146, 169 -1.7  (4.09) -2.0  (3.46)
12.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
Hide Outcome Measure Data
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 372 372
Measure Type: Number
Unit of Measure: participants
Baseline, G0 250 242
Baseline, G1 69 99
Baseline, G2 45 24
Baseline, G3 7 7
Baseline, G4 0 0
Baseline, Missing G 1 0
Maximum During Treatment (MDT), G0 81 133
MDT, G1 99 152
MDT, G2 115 64
MDT, G3 64 13
MDT, G4 3 0
MDT, Missing G 10 10
Week 12, G0 159 216
Week 12, G1 83 87
Week 12, G2 50 24
Week 12, G3 11 3
Week 12, G4 1 0
Week 12, Missing G 68 42
13.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 drying 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 372 372
Measure Type: Number
Unit of Measure: participants
Baseline, G0 329 327
Baseline, G1 34 36
Baseline, G2 6 9
Baseline, G3 2 0
Baseline, G4 0 0
Baseline, Missing G 1 0
MDT, G0 96 222
MDT, G1 101 102
MDT, G2 90 36
MDT, G3 72 2
MDT, G4 3 0
MDT, Missing G 10 10
Week 12, G0 208 292
Week 12, G1 67 33
Week 12, G2 22 5
Week 12, G3 7 0
Week 12, G4 0 0
Week 12, Missing G 68 42
14.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 372 372
Measure Type: Number
Unit of Measure: participants
Baseline, G0 344 339
Baseline, G1 22 29
Baseline, G2 5 4
Baseline, G3 0 0
Baseline, G4 0 0
Baseline, Missing G 1 0
MDT, G0 112 256
MDT, G1 104 76
MDT, G2 87 28
MDT, G3 51 2
MDT, G4 8 0
MDT, Missing G 10 10
Week 12, G0 221 300
Week 12, G1 57 25
Week 12, G2 16 5
Week 12, G3 10 0
Week 12, G4 0 0
Week 12, Missing G 68 42
15.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 372 372
Measure Type: Number
Unit of Measure: participants
Baseline, G0 237 229
Baseline, G1 104 109
Baseline, G2 26 30
Baseline, G3 3 4
Baseline, Missing G 2 0
MDT, G0 68 126
MDT, G1 164 182
MDT, G2 92 48
MDT, G3 38 6
MDT, Missing G 10 10
Week 12, G0 174 216
Week 12, G1 111 96
Week 12, G2 17 16
Week 12, G3 2 2
Week 12, Missing G 68 42
16.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 372 372
Measure Type: Number
Unit of Measure: participants
Baseline, G0 307 291
Baseline, G1 34 64
Baseline, G2 26 15
Baseline, G3 3 2
Baseline, Missing G 2 0
MDT, G0 52 137
MDT, G1 101 159
MDT, G2 122 55
MDT, G3 87 11
MDT, Missing G 10 10
Week 12, G0 179 222
Week 12, G1 94 94
Week 12, G2 24 13
Week 12, G3 7 1
Week 12, Missing G 68 42
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   1/371 (0.27%)   1/372 (0.27%) 
Injury, poisoning and procedural complications     
Brain contusion  1  0/371 (0.00%)  1/372 (0.27%) 
Nervous system disorders     
Intracranial pressure increased  1  0/371 (0.00%)  1/372 (0.27%) 
Psychiatric disorders     
Adjustment disorder with mixed disturbance of emotion, condu  1  1/371 (0.27%)  0/372 (0.00%) 
Depression  1  1/371 (0.27%)  0/372 (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   88/371 (23.72%)   17/372 (4.57%) 
General disorders     
Application Site Dryness  1  22/371 (5.93%)  2/372 (0.54%) 
Application Site Irritation  1  66/371 (17.79%)  15/372 (4.03%) 
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: NCT01017146     History of Changes
Other Study ID Numbers: 114575
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: January 18, 2017