A Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Common Facial Acne - W0260-301

• 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: Stiefel, a GSK Company
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Tazarotene Foam	Vehicle Foam
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

Baseline Characteristics

Arm/Group Title		Tazarotene Foam	Vehicle Foam	Total
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
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.

Outcome Measures

1. Primary Outcome

Title	Absolute Change in Lesion Counts (LCs) From Baseline to Week 12
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

Outcome Measure Data

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
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)

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]

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]

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
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

Outcome Measure Data

Analysis Population Description

ITT Analysis Set

Arm/Group Title	Tazarotene Foam	Vehicle Foam
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

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.

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
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

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Missing values were imputed using the LOCF method.

Arm/Group Title	Tazarotene Foam	Vehicle Foam
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

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.

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
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

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. The LOCF imputation method was used for missing data.

Arm/Group Title	Tazarotene Foam	Vehicle Foam
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
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

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Calculation was based on the LOCF imputation method for missing data.

Arm/Group Title	Tazarotene Foam	Vehicle Foam
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)
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

Outcome Measure Data

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
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
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

Outcome Measure Data

Analysis Population Description

ITT Analysis Set

Arm/Group Title	Tazarotene Foam	Vehicle Foam
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
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

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. Missing values were imputed using the LOCF method.

Arm/Group Title	Tazarotene Foam	Vehicle Foam
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
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

Outcome Measure Data

Analysis Population Description

ITT Analysis Set

Arm/Group Title	Tazarotene Foam	Vehicle Foam
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

Analysis Population Description

All Randomized Participants: all participants who were randomized in the study

Arm/Group Title	Tazarotene Foam	Vehicle Foam
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
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

Outcome Measure Data

Analysis Population Description

All Randomized Participants

Arm/Group Title	Tazarotene Foam	Vehicle Foam
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
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

Outcome Measure Data

Analysis Population Description

All Randomized Participants

Arm/Group Title	Tazarotene Foam	Vehicle Foam
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
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

Outcome Measure Data

Analysis Population Description

All Randomized Participants

Arm/Group Title	Tazarotene Foam	Vehicle Foam
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
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

Outcome Measure Data

Analysis Population Description

All Randomized Participants

Arm/Group Title	Tazarotene Foam	Vehicle Foam
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

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Tazarotene Foam	Vehicle Foam
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	--/--	--/--
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
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

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: GSK Response Center
• Organization: GlaxoSmithKline
• Phone: 866-435-7343

Publications:

Feldman SR, Werner CP, Alió Saenz AB. The efficacy and tolerability of tazarotene foam, 0.1%, in the treatment of acne vulgaris in 2 multicenter, randomized, vehicle-controlled, double-blind studies. J Drugs Dermatol. 2013 Apr;12(4):438-46.

• 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