Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Common Facial Acne (NCT NCT01017120)

NCT ID: NCT01017120

Last Updated: 2017-05-18

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: 742 participants
• Primary outcome timeframe: Baseline (Week 0/Day 1) and Week 12
• Results posted on: 2017-05-18

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	373	369
Overall Study COMPLETED	307	334
Overall Study NOT COMPLETED	66	35

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	9	0
Overall Study Lost to Follow-up	13	11
Overall Study Lack of Efficacy	1	0
Overall Study Withdrawal by Subject	39	21
Overall Study Pregnancy	1	1
Overall Study Did Not Meet Eligibility Criteria	1	0
Overall Study Relocated Out of Town	0	2
Overall Study Protocol Violation	1	0
Overall Study Parent Unable to Provide Transportation	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Tazarotene Foam n=373 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=369 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=742 Participants Total of all reporting groups
Age, Continuous	19.2 Years STANDARD_DEVIATION 6.5 • n=5 Participants	19.2 Years STANDARD_DEVIATION 6.8 • n=7 Participants	19.2 Years STANDARD_DEVIATION 6.6 • n=5 Participants
Sex: Female, Male Female	197 Participants n=5 Participants	185 Participants n=7 Participants	382 Participants n=5 Participants
Sex: Female, Male Male	176 Participants n=5 Participants	184 Participants n=7 Participants	360 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized Asian	28 participants n=5 Participants	21 participants n=7 Participants	49 participants n=5 Participants
Race/Ethnicity, Customized Black	60 participants n=5 Participants	57 participants n=7 Participants	117 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized White	278 participants n=5 Participants	280 participants n=7 Participants	558 participants n=5 Participants
Race/Ethnicity, Customized Mixed Race	5 participants n=5 Participants	5 participants n=7 Participants	10 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=373 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=369 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	-17.8 lesion counts Standard Deviation 11.81	-14.7 lesion counts Standard Deviation 10.66
Absolute Change in Lesion Counts (LCs) From Baseline to Week 12 NILs	-25.6 lesion counts Standard Deviation 17.06	-18.2 lesion counts Standard Deviation 15.21
Absolute Change in Lesion Counts (LCs) From Baseline to Week 12 TLs	-43.4 lesion counts Standard Deviation 24.27	-32.9 lesion counts Standard Deviation 21.99

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=373 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=369 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	120 participants	67 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=373 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=369 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	103 participants	49 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=373 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=369 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 percentage change Standard Deviation 26.12	-17.4 percentage change Standard Deviation 26.16
Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 ILs, Week 12	-54.5 percentage change Standard Deviation 32.79	-45.3 percentage change Standard Deviation 30.72
Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 NILs, Week 2	-23.7 percentage change Standard Deviation 25.82	-17.3 percentage change Standard Deviation 25.03
Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 NILs, Week 8	-50.6 percentage change Standard Deviation 27.35	-36.6 percentage change Standard Deviation 27.81
Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 NILs, Week 12	-56.7 percentage change Standard Deviation 28.84	-41.2 percentage change Standard Deviation 31.09
Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 TLs, Week 2	-21.6 percentage change Standard Deviation 20.44	-17.1 percentage change Standard Deviation 20.38
Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 ILs, Week 4	-32.9 percentage change Standard Deviation 30.18	-31.4 percentage change Standard Deviation 29.13
Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 ILs, Week 8	-48.1 percentage change Standard Deviation 30.99	-41.0 percentage change Standard Deviation 28.77
Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 NILs, Week 4	-39.2 percentage change Standard Deviation 27.30	-27.3 percentage change Standard Deviation 29.28
Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 TLs, Week 4	-36.8 percentage change Standard Deviation 23.43	-28.9 percentage change Standard Deviation 23.35
Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 TLs, Week 8	-49.7 percentage change Standard Deviation 24.65	-38.4 percentage change Standard Deviation 24.33
Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 TLs, Week 12	-56.0 percentage change Standard Deviation 26.76	-42.6 percentage change Standard Deviation 26.80

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=373 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=369 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 NILs, Week 4	-17.3 lesion counts Standard Deviation 13.73	-11.8 lesion counts Standard Deviation 14.37
Absolute Change From Baseline in LC at Weeks 2, 4, and 8 TLs, Week 4	-28.0 lesion counts Standard Deviation 18.85	-22.0 lesion counts Standard Deviation 19.39
Absolute Change From Baseline in LC at Weeks 2, 4, and 8 ILs, Week 2	-5.9 lesion counts Standard Deviation 8.87	-5.6 lesion counts Standard Deviation 8.80
Absolute Change From Baseline in LC at Weeks 2, 4, and 8 ILs, Week 4	-10.7 lesion counts Standard Deviation 10.41	-10.2 lesion counts Standard Deviation 9.95
Absolute Change From Baseline in LC at Weeks 2, 4, and 8 ILs, Week 8	-15.7 lesion counts Standard Deviation 11.06	-13.3 lesion counts Standard Deviation 9.77
Absolute Change From Baseline in LC at Weeks 2, 4, and 8 NILs, Week 2	-10.7 lesion counts Standard Deviation 13.37	-7.7 lesion counts Standard Deviation 12.50
Absolute Change From Baseline in LC at Weeks 2, 4, and 8 NILs, Week 8	-22.6 lesion counts Standard Deviation 15.42	-16.5 lesion counts Standard Deviation 14.26
Absolute Change From Baseline in LC at Weeks 2, 4, and 8 TLs, Week 2	-16.6 lesion counts Standard Deviation 17.15	-13.3 lesion counts Standard Deviation 17.50
Absolute Change From Baseline in LC at Weeks 2, 4, and 8 TLs, Week 8	-38.3 lesion counts Standard Deviation 21.49	-29.7 lesion counts Standard Deviation 20.42

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=265 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=194 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 56.0 to 57.0	85 days Interval 65.0 to 85.0

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=373 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=369 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 G Improvement in ISGA Score at Weeks 2, 4, and 8 Week 2	8 participants	4 participants
Number of Participants With a Minimum 2 G Improvement in ISGA Score at Weeks 2, 4, and 8 Week 4	33 participants	16 participants
Number of Participants With a Minimum 2 G Improvement in ISGA Score at Weeks 2, 4, and 8 Week 8	69 participants	35 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=373 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=369 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 4	26 participants	12 participants
Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8 Week 8	56 participants	26 participants
Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8 Week 2	5 participants	2 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=373 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=369 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	83 participants	93 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	136 participants	114 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	171 participants	125 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	213 participants	153 participants

SECONDARY outcome

Timeframe: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 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=373 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=369 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 2-G Improvement in ISGA Score and an ISGA Score of 0 or 1 at Weeks 2, 4, 8, and 12 Week 2	5 participants	2 participants
Number of Participants With a 2-G Improvement in ISGA Score and an ISGA Score of 0 or 1 at Weeks 2, 4, 8, and 12 Week 4	26 participants	12 participants
Number of Participants With a 2-G Improvement in ISGA Score and an ISGA Score of 0 or 1 at Weeks 2, 4, 8, and 12 Week 8	56 participants	26 participants
Number of Participants With a 2-G Improvement in ISGA Score and an ISGA Score of 0 or 1 at Weeks 2, 4, 8, and 12 Week 12	103 participants	49 participants

SECONDARY outcome

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

Population: ITT Analysis Set

A papule is a circumscribed, solid elevation of the skin with no visible fluid. Change from basline in papule count at Weeks 2, 4, 8, and 12 was calculated as the papule count at Week 2/4/8/12 minus the papule count at Baseline.

Outcome measures

Measure	Tazarotene Foam n=373 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=369 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 Papule Count From Baseline at Weeks 2, 4, 8, and 12 Week 2	-4.3 papule count Standard Deviation 7.23	-4.3 papule count Standard Deviation 8.28
Absolute Change in Papule Count From Baseline at Weeks 2, 4, 8, and 12 Week 4	-8.3 papule count Standard Deviation 8.76	-7.8 papule count Standard Deviation 9.27
Absolute Change in Papule Count From Baseline at Weeks 2, 4, 8, and 12 Week 8	-12.0 papule count Standard Deviation 9.55	-10.4 papule count Standard Deviation 9.13
Absolute Change in Papule Count From Baseline at Weeks 2, 4, 8, and 12 Week 12	-13.5 papule count Standard Deviation 10.06	-11.5 papule count Standard Deviation 10.00

SECONDARY outcome

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

Population: ITT Analysis Set

A pustule is a small elevation of the skin containing cloudy or purulent material usually consisting of necrotic inflammatory cells. Change from basline in pustule count at Weeks 2, 4, 8, and 12 was calculated as the pustule count at Week 2/4/8/12 minus the pustule count at Baseline.

Outcome measures

Measure	Tazarotene Foam n=373 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=369 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 Pustule Count From Baseline at Weeks 2, 4, 8, and 12 Week 2	-1.5 pustule count Standard Deviation 5.70	-1.3 pustule count Standard Deviation 4.46
Absolute Change in Pustule Count From Baseline at Weeks 2, 4, 8, and 12 Week 4	-2.4 pustule count Standard Deviation 6.21	-2.4 pustule count Standard Deviation 5.04
Absolute Change in Pustule Count From Baseline at Weeks 2, 4, 8, and 12 Week 8	-3.7 pustule count Standard Deviation 6.08	-2.9 pustule count Standard Deviation 5.14
Absolute Change in Pustule Count From Baseline at Weeks 2, 4, 8, and 12 Week 12	-4.2 pustule count Standard Deviation 6.42	-3.2 pustule count Standard Deviation 5.68

SECONDARY outcome

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

Population: ITT Analysis Set

A nodule is a slightly elevated lesion on or in the skin. Change from basline in nodule count at Weeks 2, 4, 8, and 12 was calculated as the nodule count at Week 2/4/8/12 value (s) minus the nodule count at Baseline.

Outcome measures

Measure	Tazarotene Foam n=373 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=369 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 Nodule Count From Baseline at Weeks 2, 4, 8, and 12 Week 2	-0.0 nodule count Standard Deviation 0.35	0.0 nodule count Standard Deviation 0.72
Absolute Change in Nodule Count From Baseline at Weeks 2, 4, 8, and 12 Week 4	-0.0 nodule count Standard Deviation 0.40	0.0 nodule count Standard Deviation 0.80
Absolute Change in Nodule Count From Baseline at Weeks 2, 4, 8, and 12 Week 8	-0.0 nodule count Standard Deviation 0.40	0.1 nodule count Standard Deviation 0.83
Absolute Change in Nodule Count From Baseline at Weeks 2, 4, 8, and 12 Week 12	-0.0 nodule count Standard Deviation 0.35	0.0 nodule count Standard Deviation 0.78

SECONDARY outcome

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

Population: ITT Analysis Set

An open comedone is a yellow or blackish bump or plug on the skin. Change from Baseline in open comedone count at Weeks 2, 4, 8, and 12 was calculated as the open comedone count at Week 2/4/8/12 minus the open comedone count at Baseline.

Outcome measures

Measure	Tazarotene Foam n=373 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=369 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 Open Comedone Count From Baseline at Weeks 2, 4, 8, and 12 Week 12	-8.4 open comedone count Standard Deviation 10.90	-6.9 open comedone count Standard Deviation 9.56
Absolute Change in Open Comedone Count From Baseline at Weeks 2, 4, 8, and 12 Week 2	-3.5 open comedone count Standard Deviation 8.49	-3.1 open comedone count Standard Deviation 8.20
Absolute Change in Open Comedone Count From Baseline at Weeks 2, 4, 8, and 12 Week 4	-5.8 open comedone count Standard Deviation 9.19	-4.2 open comedone count Standard Deviation 9.06
Absolute Change in Open Comedone Count From Baseline at Weeks 2, 4, 8, and 12 Week 8	-7.3 open comedone count Standard Deviation 10.13	-5.8 open comedone count Standard Deviation 9.46

SECONDARY outcome

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

Population: ITT Analysis Set

A closed comedone is a whitehead. Change from basline in closed comedone count at Weeks 2, 4, 8, and 12 was calculated as the closed comedone count at Week 2/4/8/12 minus the closed comedone count at Baseline.

Outcome measures

Measure	Tazarotene Foam n=373 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=369 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 Closed Comedone Count From Baseline at Weeks 2, 4, 8, and 12 Week 2	-7.3 closed comedone count Standard Deviation 10.84	-4.5 closed comedone count Standard Deviation 10.52
Absolute Change in Closed Comedone Count From Baseline at Weeks 2, 4, 8, and 12 Week 4	-11.5 closed comedone count Standard Deviation 12.56	-7.6 closed comedone count Standard Deviation 11.55
Absolute Change in Closed Comedone Count From Baseline at Weeks 2, 4, 8, and 12 Week 8	-15.3 closed comedone count Standard Deviation 14.10	-10.7 closed comedone count Standard Deviation 11.98
Absolute Change in Closed Comedone Count From Baseline at Weeks 2, 4, 8, and 12 Week 12	-17.2 closed comedone count Standard Deviation 14.66	-11.4 closed comedone count Standard Deviation 13.96

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 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=175 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=178 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 4, n=170, 184	-2.4 scores on a scale Standard Deviation 4.80	-2.7 scores on a scale Standard Deviation 3.92
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=162, 176	-3.7 scores on a scale Standard Deviation 5.33	-3.2 scores on a scale Standard Deviation 4.98
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=163, 176	-2.9 scores on a scale Standard Deviation 5.14	-3.1 scores on a scale Standard Deviation 4.64
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=175, 178	-1.3 scores on a scale Standard Deviation 5.28	-1.9 scores on a scale Standard Deviation 3.68

SECONDARY outcome

Timeframe: Baseline (Week 0/Day 1); Week 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 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=153 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=163 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=153, 163	1.3 scores on a scale Standard Deviation 4.01	-1.5 scores on a scale Standard Deviation 2.96
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=143, 158	-0.9 scores on a scale Standard Deviation 3.30	-1.9 scores on a scale Standard Deviation 3.33
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=137, 158	-1.6 scores on a scale Standard Deviation 3.19	-1.9 scores on a scale Standard Deviation 3.13
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=137, 153	-1.6 scores on a scale Standard Deviation 4.06	-2.0 scores on a scale Standard Deviation 3.58

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=373 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=369 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 MDT, G4	2 participants	0 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator Week 12, G0	175 participants	218 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator Baseline, G0	247 participants	234 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator Baseline, G1	65 participants	75 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator Baseline, G2	21 participants	20 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator Baseline, G3	40 participants	40 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	0 participants	0 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator Maximum During Treatment (MDT), G0	76 participants	141 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator MDT, G1	117 participants	132 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator MDT, G2	111 participants	51 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator MDT, G3	56 participants	37 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator MDT, Missing G	11 participants	8 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator Week 12, G1	93 participants	73 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator Week 12, G2	30 participants	21 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator Week 12, G3	9 participants	19 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator Week 12, G4	0 participants	0 participants
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator Week 12, Missing G	66 participants	38 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 dryness reported at any time during treatment.

Outcome measures

Measure	Tazarotene Foam n=373 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=369 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 MDT, G4	5 participants	1 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator MDT, Missing G	11 participants	8 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator Week 12, G3	1 participants	0 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator Baseline, G0	316 participants	312 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator Baseline, G1	39 participants	43 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator Baseline, G2	13 participants	8 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator Baseline, G3	5 participants	6 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	0 participants	0 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator MDT, G0	73 participants	193 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator MDT, G1	136 participants	124 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator MDT, G2	87 participants	36 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator MDT, G3	61 participants	7 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator Week 12, G0	219 participants	294 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator Week 12, G1	73 participants	35 participants
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator Week 12, G2	14 participants	2 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	66 participants	38 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=373 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=369 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, G4	0 participants	0 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator Baseline, Missing G	0 participants	0 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator MDT, G0	108 participants	255 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator MDT, G1	152 participants	85 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator MDT, G2	69 participants	18 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator MDT, G3	28 participants	3 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator MDT, G4	5 participants	0 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator MDT, Missing G	11 participants	8 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator Week 12, G0	251 participants	313 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator Week 12, G2	7 participants	1 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator Week 12, G3	1 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	66 participants	38 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator Baseline, G1	22 participants	18 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator Baseline, G2	7 participants	6 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator Baseline, G3	2 participants	6 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator Week 12, G1	48 participants	17 participants
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator Baseline, G0	342 participants	339 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=373 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=369 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	205 participants	209 participants
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants Baseline, G1	133 participants	131 participants
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants Baseline, G3	4 participants	2 participants
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants Baseline, Missing G	0 participants	0 participants
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants MDT, G0	57 participants	145 participants
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants MDT, G1	169 participants	155 participants
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants MDT, G2	96 participants	51 participants
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants MDT, G3	39 participants	10 participants
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants MDT, Missing G	12 participants	8 participants
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants Week 12, G0	176 participants	224 participants
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants Week 12, G3	4 participants	6 participants
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants Week 12, Missing G	66 participants	38 participants
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants Baseline, G2	31 participants	27 participants
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants Week 12, G1	105 participants	88 participants
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants Week 12, G2	22 participants	13 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=373 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=369 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 Baseline, G0	299 participants	290 participants
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants Baseline, G1	60 participants	62 participants
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants Baseline, G2	12 participants	16 participants
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants Baseline, G3	2 participants	1 participants
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants Baseline, Missing G	0 participants	0 participants
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants MDT, G0	57 participants	109 participants
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants MDT, G1	169 participants	181 participants
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants MDT, G3	104 participants	16 participants
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants MDT, Missing G	12 participants	8 participants
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants Week 12, G0	168 participants	223 participants
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants Week 12, G1	97 participants	86 participants
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants Week 12, G3	8 participants	7 participants
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants Week 12, Missing G	66 participants	38 participants
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants MDT, G2	105 participants	55 participants
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants Week 12, G2	34 participants	15 participants

Adverse Events

Tazarotene Foam

Serious events: 1 serious events

Other events: 69 other events

Deaths: 0 deaths

Vehicle Foam

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tazarotene Foam n=373 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=369 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.
Nervous system disorders Convulsion	0.27% 1/373	0.00% 0/369

Other adverse events

Measure	Tazarotene Foam n=373 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=369 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	7.5% 28/373	1.6% 6/369
General disorders Application Site Irritation	11.0% 41/373	1.1% 4/369

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