Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Common Facial Acne - W0260-301 (NCT NCT01017146)

NCT ID: NCT01017146

Last Updated: 2017-01-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 744 participants
• Primary outcome timeframe: Baseline (Week 0/Day 1) and Week 12
• Results posted on: 2017-01-18

Participant Flow

Participant milestones

Measure	Tazarotene Foam 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.	Vehicle Foam 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 Study STARTED	372	372
Overall Study COMPLETED	306	333
Overall Study NOT COMPLETED	66	39

Reasons for withdrawal

Measure	Tazarotene Foam 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.	Vehicle Foam 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 Study Adverse Event	11	1
Overall Study Lost to Follow-up	14	14
Overall Study Noncompliance with Study Product	1	1
Overall Study Withdrawal by Subject	32	16
Overall Study Relocation	0	4
Overall Study Pregnancy	2	1
Overall Study Protocol Violation	2	0
Overall Study Took Excluded Medication	2	0
Overall Study Did Not Meet Eligibility Criteria	1	2
Overall Study Change in Work Situation	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Tazarotene Foam n=371 Participants 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.	Vehicle Foam n=372 Participants 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 n=743 Participants Total of all reporting groups
Age, Continuous Years	18.2 Years STANDARD_DEVIATION 5.7 • n=5 Participants	18.6 Years STANDARD_DEVIATION 6.4 • n=7 Participants	18.4 Years STANDARD_DEVIATION 6.1 • n=5 Participants
Gender Female	182 Participants n=5 Participants	192 Participants n=7 Participants	374 Participants n=5 Participants
Gender Male	189 Participants n=5 Participants	180 Participants n=7 Participants	369 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	12 participants n=5 Participants	3 participants n=7 Participants	15 participants n=5 Participants
Race/Ethnicity, Customized Asian	11 participants n=5 Participants	4 participants n=7 Participants	15 participants n=5 Participants
Race/Ethnicity, Customized Black	53 participants n=5 Participants	50 participants n=7 Participants	103 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized White	285 participants n=5 Participants	307 participants n=7 Participants	592 participants n=5 Participants
Race/Ethnicity, Customized Mixed Race	10 participants n=5 Participants	7 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0/Day 1) and Week 12

Population: 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.

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.

Outcome measures

Measure	Tazarotene Foam n=371 Participants 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.	Vehicle Foam n=372 Participants 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.
Absolute Change in Lesion Counts (LCs) From Baseline to Week 12 ILs	-18.0 lesion counts Standard Deviation 11.01	-14.1 lesion counts Standard Deviation 12.37
Absolute Change in Lesion Counts (LCs) From Baseline to Week 12 NILs	-27.9 lesion counts Standard Deviation 21.65	-16.7 lesion counts Standard Deviation 21.72
Absolute Change in Lesion Counts (LCs) From Baseline to Week 12 TLs	-45.8 lesion counts Standard Deviation 27.89	-30.8 lesion counts Standard Deviation 26.68

PRIMARY outcome

Timeframe: Baseline (Week 0/Day 1) and Week 12

Population: ITT Analysis Set

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.

Outcome measures

Measure	Tazarotene Foam n=371 Participants 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.	Vehicle Foam n=372 Participants 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.
Number of Participants With a Minimum 2-grade (G) Improvement in the Investigator Static Global Assessment (ISGA) Score From Baseline at Week 12	132 participants	89 participants

PRIMARY outcome

Timeframe: Week 12

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

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.

Outcome measures

Measure	Tazarotene Foam n=371 Participants 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.	Vehicle Foam n=372 Participants 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.
Number of Participants With an ISGA Score of 0 or 1 at Week 12	107 participants	60 participants

SECONDARY outcome

Timeframe: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12

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

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.

Outcome measures

Measure	Tazarotene Foam n=371 Participants 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.	Vehicle Foam n=372 Participants 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.
Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 ILs, Week 2	-18.2 percent change Standard Deviation 35.84	-20.9 percent change Standard Deviation 33.64
Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 ILs, Week 4	-33.0 percent change Standard Deviation 32.75	-24.8 percent change Standard Deviation 34.42
Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 ILs, Week 8	-50.1 percent change Standard Deviation 31.53	-42.1 percent change Standard Deviation 38.62
Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 ILs, Week 12	-57.5 percent change Standard Deviation 33.39	-45.2 percent change Standard Deviation 38.64
Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 NILs, Week 2	-24.5 percent change Standard Deviation 26.21	-16.6 percent change Standard Deviation 28.64
Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 NILs, Week 4	-36.6 percent change Standard Deviation 28.59	-25.0 percent change Standard Deviation 32.45
Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 NILs, Week 8	-48.7 percent change Standard Deviation 29.20	-30.6 percent change Standard Deviation 36.64
Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 NILs, Week 12	-55.1 percent change Standard Deviation 30.88	-34.3 percent change Standard Deviation 42.56
Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 TLs, Week 2	-22.5 percent change Standard Deviation 23.39	-18.8 percent change Standard Deviation 22.21
Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 TLs, Week 4	-35.3 percent change Standard Deviation 25.41	-29.3 percent change Standard Deviation 26.98
Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 TLs, Week 8	-49.5 percent change Standard Deviation 26.2	-35.6 percent change Standard Deviation 31.16
Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 TLs, Week 12	-56.3 percent change Standard Deviation 28.52	-39.0 percent change Standard Deviation 34.40

SECONDARY outcome

Timeframe: Baseline (Week 0/Day 1); Weeks 2, 4, and 8

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

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.

Outcome measures

Measure	Tazarotene Foam n=371 Participants 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.	Vehicle Foam n=372 Participants 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.
Absolute Change From Baseline in LC at Weeks 2, 4, and 8 ILs, Week 2	-5.5 lesion counts Standard Deviation 11.54	-6.5 lesion counts Standard Deviation 11.98
Absolute Change From Baseline in LC at Weeks 2, 4, and 8 ILs, Week 4	-10.1 lesion counts Standard Deviation 10.44	-10.9 lesion counts Standard Deviation 11.74
Absolute Change From Baseline in LC at Weeks 2, 4, and 8 ILs, Week 8	-15.6 lesion counts Standard Deviation 10.40	-13.2 lesion counts Standard Deviation 12.71
Absolute Change From Baseline in LC at Weeks 2, 4, and 8 NILs, Week 2	-12.6 lesion counts Standard Deviation 15.72	-8.6 lesion counts Standard Deviation 16.22
Absolute Change From Baseline in LC at Weeks 2, 4, and 8 NILs, Week 4	-18.2 lesion counts Standard Deviation 17.70	-12.2 lesion counts Standard Deviation 18.41
Absolute Change From Baseline in LC at Weeks 2, 4, and 8 NILs, Week 8	-24.6 lesion counts Standard Deviation 19.64	-14.8 lesion counts Standard Deviation 21.63
Absolute Change From Baseline in LC at Weeks 2, 4, and 8 TLs, Week 2	-18.1 lesion counts Standard Deviation 20.22	-15.1 lesion counts Standard Deviation 18.80
Absolute Change From Baseline in LC at Weeks 2, 4, and 8 TLs, Week 4	-28.3 lesion counts Standard Deviation 22.77	-23.1 lesion counts Standard Deviation 23.30
Absolute Change From Baseline in LC at Weeks 2, 4, and 8 TLs, Week 8	-40.1 lesion counts Standard Deviation 24.67	-27.9 lesion counts Standard Deviation 28.09

SECONDARY outcome

Timeframe: Baseline (Week 0/Day 1) to Week 12

Population: ITT Analysis Set: only those participants with a \>=50 percent reduction from Baseline in TLC were evaluated.

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.

Outcome measures

Measure	Tazarotene Foam n=273 Participants 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.	Vehicle Foam n=197 Participants 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.
Time to a 50 Percent Reduction in Total Lesion Counts (TLC)	57 days Interval 57.0 to 58.0	85 days Interval 80.0 to 86.0

SECONDARY outcome

Timeframe: Baseline (Week 0/Day 1); Weeks 2, 4, and 8

Population: ITT Analysis Set

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.

Outcome measures

Measure	Tazarotene Foam n=371 Participants 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.	Vehicle Foam n=372 Participants 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.
Number of Participants With a Minimum 2-grade Improvement in ISGA Score at Weeks 2, 4, and 8 Week 2	10 participants	11 participants
Number of Participants With a Minimum 2-grade Improvement in ISGA Score at Weeks 2, 4, and 8 Week 4	23 participants	29 participants
Number of Participants With a Minimum 2-grade Improvement in ISGA Score at Weeks 2, 4, and 8 Week 8	64 participants	44 participants

SECONDARY outcome

Timeframe: Weeks 2, 4, and 8

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

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.

Outcome measures

Measure	Tazarotene Foam n=371 Participants 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.	Vehicle Foam n=372 Participants 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.
Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8 Week 2	4 participants	1 participants
Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8 Week 4	12 participants	7 participants
Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8 Week 8	40 participants	22 participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, and 12

Population: ITT Analysis Set

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.

Outcome measures

Measure	Tazarotene Foam n=371 Participants 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.	Vehicle Foam n=372 Participants 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.
Number of Participants With a Subject's Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12 Week 2	104 participants	1 participants
Number of Participants With a Subject's Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12 Week 4	143 participants	130 participants
Number of Participants With a Subject's Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12 Week 8	187 participants	165 participants
Number of Participants With a Subject's Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12 Week 12	220 participants	180 participants

SECONDARY outcome

Timeframe: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12

Population: 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.

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.

Outcome measures

Measure	Tazarotene Foam n=171 Participants 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.	Vehicle Foam n=165 Participants 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.
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 Week 2, n=171,165	-0.1 Scores on a scale Standard Deviation 4.98	-2.1 Scores on a scale Standard Deviation 3.68
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 Week 4, n=166, 167	-1.9 Scores on a scale Standard Deviation 4.60	-2.5 Scores on a scale Standard Deviation 3.85
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 Week 8, n=160, 155	-2.9 Scores on a scale Standard Deviation 4.86	-2.7 Scores on a scale Standard Deviation 4.40
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 Week 12, n=154, 155	-3.6 Scores on a scale Standard Deviation 5.22	-3.1 Scores on a scale Standard Deviation 4.31

SECONDARY outcome

Timeframe: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12

Population: 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.

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.

Outcome measures

Measure	Tazarotene Foam n=162 Participants 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.	Vehicle Foam n=179 Participants 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.
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 Week 2, n=162,179	1.1 scores on a scale Standard Deviation 4.16	-1.4 scores on a scale Standard Deviation 3.21
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 Week 4, n=153, 180	-0.6 scores on a scale Standard Deviation 3.45	-1.4 scores on a scale Standard Deviation 3.23
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 Week 8, n=148, 171	-1.2 scores on a scale Standard Deviation 3.53	-1.9 scores on a scale Standard Deviation 3.11
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 Week 12, n=146, 169	-1.7 scores on a scale Standard Deviation 4.09	-2.0 scores on a scale Standard Deviation 3.46

SECONDARY outcome

Timeframe: Baseline (Week 0/Day 1) to Week 12

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

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.

Outcome measures

Measure	Tazarotene Foam n=372 Participants 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.	Vehicle Foam n=372 Participants 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.
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator Baseline, G0	250 participants	242 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator Baseline, G1	69 participants	99 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator Baseline, G2	45 participants	24 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator Baseline, G3	7 participants	7 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator Baseline, G4	0 participants	0 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator Baseline, Missing G	1 participants	0 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator Maximum During Treatment (MDT), G0	81 participants	133 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator MDT, G1	99 participants	152 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator MDT, G2	115 participants	64 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator MDT, G3	64 participants	13 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator MDT, G4	3 participants	0 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator MDT, Missing G	10 participants	10 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator Week 12, G0	159 participants	216 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator Week 12, G1	83 participants	87 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator Week 12, G2	50 participants	24 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator Week 12, G3	11 participants	3 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator Week 12, G4	1 participants	0 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator Week 12, Missing G	68 participants	42 participants

SECONDARY outcome

Timeframe: Baseline (Week 0/Day 1) to Week 12

Population: All Randomized Participants

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.

Outcome measures

Measure	Tazarotene Foam n=372 Participants 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.	Vehicle Foam n=372 Participants 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.
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator Baseline, G0	329 participants	327 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator Baseline, G1	34 participants	36 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator Baseline, G2	6 participants	9 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator Baseline, G3	2 participants	0 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator Baseline, G4	0 participants	0 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator Baseline, Missing G	1 participants	0 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator MDT, G0	96 participants	222 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator MDT, G1	101 participants	102 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator MDT, G2	90 participants	36 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator MDT, G3	72 participants	2 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator MDT, G4	3 participants	0 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator MDT, Missing G	10 participants	10 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator Week 12, G0	208 participants	292 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator Week 12, G1	67 participants	33 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator Week 12, G2	22 participants	5 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator Week 12, G3	7 participants	0 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator Week 12, G4	0 participants	0 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator Week 12, Missing G	68 participants	42 participants

SECONDARY outcome

Timeframe: Baseline (Week 0/Day 1) to Week 12

Population: All Randomized Participants

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.

Outcome measures

Measure	Tazarotene Foam n=372 Participants 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.	Vehicle Foam n=372 Participants 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.
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator Baseline, G0	344 participants	339 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator Baseline, G1	22 participants	29 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator Baseline, G2	5 participants	4 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator Baseline, G3	0 participants	0 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator Baseline, G4	0 participants	0 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator Baseline, Missing G	1 participants	0 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator MDT, G0	112 participants	256 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator MDT, G1	104 participants	76 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator MDT, G2	87 participants	28 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator MDT, G3	51 participants	2 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator MDT, G4	8 participants	0 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator MDT, Missing G	10 participants	10 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator Week 12, G0	221 participants	300 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator Week 12, G1	57 participants	25 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator Week 12, G2	16 participants	5 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator Week 12, G3	10 participants	0 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator Week 12, G4	0 participants	0 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator Week 12, Missing G	68 participants	42 participants

SECONDARY outcome

Timeframe: Baseline (Week 0/Day 1) to Week 12

Population: All Randomized Participants

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.

Outcome measures

Measure	Tazarotene Foam n=372 Participants 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.	Vehicle Foam n=372 Participants 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.
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants Baseline, G0	237 participants	229 participants
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants Baseline, G1	104 participants	109 participants
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants Baseline, G2	26 participants	30 participants
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants Baseline, G3	3 participants	4 participants
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants Baseline, Missing G	2 participants	0 participants
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants MDT, G0	68 participants	126 participants
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants MDT, G1	164 participants	182 participants
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants MDT, G2	92 participants	48 participants
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants MDT, G3	38 participants	6 participants
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants MDT, Missing G	10 participants	10 participants
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants Week 12, G0	174 participants	216 participants
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants Week 12, G1	111 participants	96 participants
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants Week 12, G2	17 participants	16 participants
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants Week 12, G3	2 participants	2 participants
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants Week 12, Missing G	68 participants	42 participants

SECONDARY outcome

Timeframe: Baseline (Week 0/Day 1) to Week 12

Population: All Randomized Participants

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.

Outcome measures

Measure	Tazarotene Foam n=372 Participants 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.	Vehicle Foam n=372 Participants 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.
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants Week 12, G2	24 participants	13 participants
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants Baseline, G0	307 participants	291 participants
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants Baseline, G1	34 participants	64 participants
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants Baseline, G2	26 participants	15 participants
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants Baseline, G3	3 participants	2 participants
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants Baseline, Missing G	2 participants	0 participants
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants MDT, G0	52 participants	137 participants
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants MDT, G1	101 participants	159 participants
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants MDT, G2	122 participants	55 participants
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants MDT, G3	87 participants	11 participants
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants MDT, Missing G	10 participants	10 participants
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants Week 12, G0	179 participants	222 participants
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants Week 12, G1	94 participants	94 participants
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants Week 12, G3	7 participants	1 participants
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants Week 12, Missing G	68 participants	42 participants

Adverse Events

Tazarotene Foam

Serious events: 1 serious events

Other events: 88 other events

Deaths: 0 deaths

Vehicle Foam

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tazarotene Foam n=371 participants at risk 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.	Vehicle Foam n=372 participants at risk 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.
Injury, poisoning and procedural complications Brain contusion	0.00% 0/371	0.27% 1/372
Nervous system disorders Intracranial pressure increased	0.00% 0/371	0.27% 1/372
Psychiatric disorders Adjustment disorder with mixed disturbance of emotion, condu	0.27% 1/371	0.00% 0/372
Psychiatric disorders Depression	0.27% 1/371	0.00% 0/372

Other adverse events

Measure	Tazarotene Foam n=371 participants at risk 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.	Vehicle Foam n=372 participants at risk 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.
General disorders Application Site Dryness	5.9% 22/371	0.54% 2/372
General disorders Application Site Irritation	17.8% 66/371	4.0% 15/372

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER