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

• Sponsor: Stiefel, a GSK Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01017146
• Collaborator: GlaxoSmithKline (Industry)
• Enrollment: 744
• Locations: 22
• Arms: 2
• Duration (Months): 13
• Patients Per Site: 33.8
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief Summary

The purpose of this study is to assess safety and efficacy of a new foam formulation of tazarotene in subjects with acne vulgaris.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Tazarotene foam; Drug: Vehicle Foam	Phase 3

Detailed Description

A multicenter, randomized, double-blind, vehicle-controlled, parallel-group study comparing tazarotene foam with vehicle foam in subjects with acne vulgaris. Approximately 742 subjects will be enrolled and randomized to 1 of the 2 study product groups in a 1:1 ratio (tazarotene foam: vehicle foam). Subjects will apply tazarotene foam or vehicle foam to the entire face once daily for 12 weeks; study visits will occur at baseline (week 0/day 1) and at weeks 2, 4, 8, and 12.

Study Design

• Study Type: Interventional
• Actual Enrollment: 744 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Acne Vulgaris
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Tazarotene foam, 0.1%	Drug: Tazarotene foam; Tazarotene foam once a day application to the face
Placebo Comparator: 2 Vehicle Foam	Drug: Vehicle Foam; Vehicle Foam once a day application to the face

Outcome Measures

Primary Outcome Measures

1. Absolute Change in Lesion Counts (LCs) From Baseline to Week 12 [Baseline (Week 0/Day 1) and Week 12]

   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.

2. Number of Participants With a Minimum 2-grade (G) Improvement in the Investigator Static Global Assessment (ISGA) Score From Baseline at Week 12 [Baseline (Week 0/Day 1) and Week 12]

   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.

3. Number of Participants With an ISGA Score of 0 or 1 at Week 12 [Week 12]

   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.

Secondary Outcome Measures

1. Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 [Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12]

   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.

2. Absolute Change From Baseline in LC at Weeks 2, 4, and 8 [Baseline (Week 0/Day 1); Weeks 2, 4, and 8]

   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.

3. Time to a 50 Percent Reduction in Total Lesion Counts (TLC) [Baseline (Week 0/Day 1) to Week 12]

   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.

4. Number of Participants With a Minimum 2-grade Improvement in ISGA Score at Weeks 2, 4, and 8 [Baseline (Week 0/Day 1); Weeks 2, 4, and 8]

   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.

5. Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8 [Weeks 2, 4, and 8]

   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.

6. Number of Participants With a Subject's Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12 [Weeks 2, 4, 8, and 12]

   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.

7. 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 [Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12]

   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.

8. 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 [Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12]

   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.

9. Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator [Baseline (Week 0/Day 1) to Week 12]

   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.

10. Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator [Baseline (Week 0/Day 1) to Week 12]

    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.

11. Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator [Baseline (Week 0/Day 1) to Week 12]

    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.

12. Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants [Baseline (Week 0/Day 1) to Week 12]

    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.

13. Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants [Baseline (Week 0/Day 1) to Week 12]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female age 12 through 45 years, inclusive, who is in good general health.

• An ISGA score of 3 or greater at baseline.

• Lesion counts meeting both of the following criteria:

1. Between 25 and 50 facial inflammatory lesions and no more than 1 facial nodular lesion (<5mm), with NO cystic lesions.

2. Between 30 and 125 facial noninflammatory lesions, excluding nasal lesions.

• Regular menstrual cycle prior to study entry for females of childbearing potential.

• Negative urine pregnancy test for females of childbearing potential. • Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses.

Women who are not currently sexually active must agree to use medically accepted method of contraception should they become sexually active while participating in the study. Male subjects and/or their partners must use a medically acceptable form of contraception.

• Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed.

• Ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.

Exclusion Criteria:

• Female who is pregnant, trying to become pregnant, or breast feeding.

• Use of topical antibiotics on the face within the past 2 weeks.

• Use of systemic antibiotics for acne treatment within the past 4 weeks.

• Concurrent use of medications known to be photosensitizers (eg, thiazides, tetracyclines) because of the possibility of augmented photosensitivity.

• Use of topical corticosteroids on the face within the past 2 weeks or systemic corticosteroids within the past 4 weeks.

• Use of systemic retinoids (eg, isotretinoin) within the past 6 months.

• Treatment with estrogens, androgens, or anti-androgenic agents for 12 weeks or less immediately prior to study enrollment. Subjects that have been treated with these medications for more than 12 consecutive weeks prior to study enrollment are allowed to enroll as long as they do not expect to change the dose or drug, or to discontinue use during the study and it has not been indicated for the treatment of acne vulgaris.

• Use of topical anti-acne medications (eg, benzoyl peroxide, retinoids, or salicylates) within the past 2 weeks.

• Concomitant use of facial products such as: abradants, facials, peels containing glycolic or other acids, masks, washes or soaps.

• Concomitant use of medications that are reported to exacerbate acne (eg, mega-doses of certain vitamins, haloperidol, and immunosuppressants such as cyclosporine) as these may impact efficacy assessments. Multivitamins, iron supplements, and folate are acceptable.

• Facial procedure (eg, blue light, chemical or laser peel, or microdermabrasion) within the past 4 weeks.

• Require or desire excessive or prolonged exposure to ultraviolet light during the study.

• Known hypersensitivity or previous allergic reaction to any of the active components of the study product.

• A significant medical history of or currently immunocompromised.

• Use of any investigational product within the past 4 weeks or currently participating in another clinical study.

• Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.

• Any major illness within 30 days before study enrollment.

• Currently lives in the same household as currently enrolled subjects; is an employee of Stiefel, an investigator, or a CRO involved in the study; or is an immediate family member (eg, partner, offspring, parents) of an employee involved in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cherry Creek Research, Inc.	Denver	Colorado	United States	80209
2	Cosmetic Medicine & Treatment Research Insttitute, Inc.	Miami Beach	Florida	United States	33140
3	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana	United States	46260
4	Minnesota Clinical Study Center	Fridley	Minnesota	United States	55432
5	Academic Dermatology Associates	Albuquerque	New Mexico	United States	87106
6	DermResearch Center of New York, Inc.	Stony Brook	New York	United States	11790
7	Dermatology Consulting Services	High Point	North Carolina	United States	27262
8	Wake Forest University Health Sciences	Winston Salem	North Carolina	United States	27157
9	The Dermatology Research of Cincinnati	Cincinnati	Ohio	United States	45220
10	Group Health Associates	Cincinnatti	Ohio	United States	45220
11	Haber Dermatology & Cosmetic Surgery, Inc.	South Euclid	Ohio	United States	44118
12	Oregon Dermatology and Research Center	Portland	Oregon	United States	97210
13	Yardley Dermatology Associates	Yardley	Pennsylvania	United States	19067
14	The Skin Wellness Center, PC	Knoxville	Tennessee	United States	37922
15	Dermatology Research Associates, Inc.	Nashville	Tennessee	United States	37203
16	DermResearch, Inc.	Austin	Texas	United States	78759
17	J & S Studies, Inc.	College Station	Texas	United States	77845
18	Dermatology Treatment & Research Center	Dallas	Texas	United States	75230
19	Aurora Advanced Healthcare, Inc. Clinical Research Center	Milwaukee	Wisconsin	United States	53209
20	Ultranova Skincare	Barrie	Ontario	Canada	L4M 6L2
21	Dermatrials Research	Hamilton	Ontario	Canada	L8N 1V6
22	Nexus Clinical Research	St. John's		Canada	NL A1B 3E1

Sponsors and Collaborators

• Stiefel, a GSK Company
• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Publications

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

• Responsible Party: Stiefel, a GSK Company
• ClinicalTrials.gov Identifier: NCT01017146
• Other Study ID Numbers: 114575
• First Posted: Nov 20, 2009
• Last Update Posted: Jan 18, 2017
• Last Verified: Nov 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Stiefel, a GSK Company: Ance
• Additional relevant MeSH terms: Acne Vulgaris; Tazarotene

Study Results

Participant Flow

Arm/Group Title	Tazarotene Foam	Vehicle Foam
Arm/Group Description	Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.	The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Period Title: Overall Study
STARTED	372	372
COMPLETED	306	333
NOT COMPLETED	66	39

Baseline Characteristics

Arm/Group Title	Tazarotene Foam	Vehicle Foam	Total
Arm/Group Description	Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.	The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.	Total of all reporting groups
Overall Participants	371	372	743
Age (Years) [Mean (Standard Deviation) ]
Years	18.2 (5.7)	18.6 (6.4)	18.4 (6.1)
Gender (Count of Participants)
Female	182 49.1%	192 51.6%	374 50.3%
Male	189 50.9%	180 48.4%	369 49.7%
Race/Ethnicity, Customized (participants) [Number]
American Indian or Alaska Native	12 3.2%	3 0.8%	15 2%
Asian	11 3%	4 1.1%	15 2%
Black	53 14.3%	50 13.4%	103 13.9%
Native Hawaiian or Other Pacific Islander	0 0%	1 0.3%	1 0.1%
White	285 76.8%	307 82.5%	592 79.7%
Mixed Race	10 2.7%	7 1.9%	17 2.3%

Outcome Measures

1. Primary Outcome

Title	Absolute Change in Lesion Counts (LCs) From Baseline to Week 12
Description	LC: count of all inflammatory lesions (ILs, i.e., papules, pustules, and nodules) and non-inflammatory lesions (NILs, i.e., open and closed comedones) at Baseline and at Week 12. Total lesions (TLs) were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline.
Time Frame	Baseline (Week 0/Day 1) and Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Analysis Set: all randomized participants who were dispensed study product. Calculation was based on the last observation carried forward (LOCF) imputation method for missing data, in which missing final values of the outcome variable are replaced by the last known value before the participant was lost to follow up.

Arm/Group Title	Tazarotene Foam	Vehicle Foam
Arm/Group Description	Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.	The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Measure Participants	371	372
ILs	-18.0 (11.01)	-14.1 (12.37)
NILs	-27.9 (21.65)	-16.7 (21.72)
TLs	-45.8 (27.89)	-30.8 (26.68)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tazarotene Foam, Vehicle Foam
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The p-value indicates treatment differences between tazarotene foam and vehicle foam for ILs
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tazarotene Foam, Vehicle Foam
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The p-value indicates treatment differences between tazarotene foam and vehicle foam for NILs
	Method	ANCOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tazarotene Foam, Vehicle Foam
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The p-value indicates treatment differences between tazarotene foam and vehicle foam for TLs
	Method	ANCOVA
	Comments

2. Primary Outcome

Title	Number of Participants With a Minimum 2-grade (G) Improvement in the Investigator Static Global Assessment (ISGA) Score From Baseline at Week 12
Description	Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.
Time Frame	Baseline (Week 0/Day 1) and Week 12

Outcome Measure Data

Analysis Population Description

ITT Analysis Set

Arm/Group Title	Tazarotene Foam	Vehicle Foam
Arm/Group Description	Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.	The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Measure Participants	371	372
Number [participants]	132 35.6%	89 23.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tazarotene Foam, Vehicle Foam
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Percentage of participants
	Estimated Value	35.6
	Confidence Interval	(2-Sided) 95%; 30.7 to 40.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	The estimated value represents the percentage of participants receiving tazarotene foam with a minimum 2 G improvement in the ISGA score from Baseline at Week 12.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Vehicle Foam
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage of participants
	Estimated Value	23.9
	Confidence Interval	(2-Sided) 95%; 19.6 to 28.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	The estimated value represents the percentage of participants receiving vehicle foam with a minimum 2 G improvement in the ISGA score from Baseline at Week 12.

3. Primary Outcome

Title	Number of Participants With an ISGA Score of 0 or 1 at Week 12
Description	Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tazarotene Foam	Vehicle Foam
Arm/Group Description	Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.	The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Measure Participants	371	372
Number [participants]	107 28.8%	60 16.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tazarotene Foam, Vehicle Foam
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Percentage of participants
	Estimated Value	28.8
	Confidence Interval	(2-Sided) 95%; 24.2 to 33.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	The estimated value represents the percentage of participants receiving tazarotene foam with an ISGA score of 0 or 1 at Week 12.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Vehicle Foam
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage of participants
	Estimated Value	16.1
	Confidence Interval	(2-Sided) 95%; 12.4 to 19.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	The estimated value represents the percentage of participants receiving vehicle foam with an ISGA score of 0 or 1 at Week 12.

4. Secondary Outcome

Title	Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12
Description	LC: count of all ILs (i.e., papules, pustules, and nodules) and NILs (i.e., open and closed comedones) at Baseline and at Week 12. TLs were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Percent change from Baseline in LC at Weeks 2, 4, 8, and12 was calculated as the (Week 2/4/8/12 value minus the baseline value divided by baseline value) x 100.
Time Frame	Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tazarotene Foam	Vehicle Foam
Arm/Group Description	Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.	The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Measure Participants	371	372
ILs, Week 2	-18.2 (35.84)	-20.9 (33.64)
ILs, Week 4	-33.0 (32.75)	-24.8 (34.42)
ILs, Week 8	-50.1 (31.53)	-42.1 (38.62)
ILs, Week 12	-57.5 (33.39)	-45.2 (38.64)
NILs, Week 2	-24.5 (26.21)	-16.6 (28.64)
NILs, Week 4	-36.6 (28.59)	-25.0 (32.45)
NILs, Week 8	-48.7 (29.20)	-30.6 (36.64)
NILs, Week 12	-55.1 (30.88)	-34.3 (42.56)
TLs, Week 2	-22.5 (23.39)	-18.8 (22.21)
TLs, Week 4	-35.3 (25.41)	-29.3 (26.98)
TLs, Week 8	-49.5 (26.2)	-35.6 (31.16)
TLs, Week 12	-56.3 (28.52)	-39.0 (34.40)

5. Secondary Outcome

Title	Absolute Change From Baseline in LC at Weeks 2, 4, and 8
Description	LC: count of all ILs (i.e., papules, pustules, and nodules) and NILs (i.e., open and closed comedones) at Baseline and at Week 12. TLs were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at baseline. Calculation was based on last observation carried forward (LOCF) imputation method for missing data.
Time Frame	Baseline (Week 0/Day 1); Weeks 2, 4, and 8

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tazarotene Foam	Vehicle Foam
Arm/Group Description	Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.	The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Measure Participants	371	372
ILs, Week 2	-5.5 (11.54)	-6.5 (11.98)
ILs, Week 4	-10.1 (10.44)	-10.9 (11.74)
ILs, Week 8	-15.6 (10.40)	-13.2 (12.71)
NILs, Week 2	-12.6 (15.72)	-8.6 (16.22)
NILs, Week 4	-18.2 (17.70)	-12.2 (18.41)
NILs, Week 8	-24.6 (19.64)	-14.8 (21.63)
TLs, Week 2	-18.1 (20.22)	-15.1 (18.80)
TLs, Week 4	-28.3 (22.77)	-23.1 (23.30)
TLs, Week 8	-40.1 (24.67)	-27.9 (28.09)

6. Secondary Outcome

Title	Time to a 50 Percent Reduction in Total Lesion Counts (TLC)
Description	Time to a 50 percent reduction in TLC (sum of ILs and NILs) was the time difference between Baseline and the time to 50 percent reduction in LC. Participants who did not have a >=50 percent reduction from Baseline in TLC during the study were censored at their last visit date.
Time Frame	Baseline (Week 0/Day 1) to Week 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tazarotene Foam	Vehicle Foam
Arm/Group Description	Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.	The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Measure Participants	273	197
Median (95% Confidence Interval) [days]	57	85

7. Secondary Outcome

Title	Number of Participants With a Minimum 2-grade Improvement in ISGA Score at Weeks 2, 4, and 8
Description	Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.
Time Frame	Baseline (Week 0/Day 1); Weeks 2, 4, and 8

Outcome Measure Data

Analysis Population Description

ITT Analysis Set

Arm/Group Title	Tazarotene Foam	Vehicle Foam
Arm/Group Description	Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.	The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Measure Participants	371	372
Week 2	10 2.7%	11 3%
Week 4	23 6.2%	29 7.8%
Week 8	64 17.3%	44 11.8%

8. Secondary Outcome

Title	Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8
Description	Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.
Time Frame	Weeks 2, 4, and 8

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tazarotene Foam	Vehicle Foam
Arm/Group Description	Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.	The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Measure Participants	371	372
Week 2	4 1.1%	1 0.3%
Week 4	12 3.2%	7 1.9%
Week 8	40 10.8%	22 5.9%

9. Secondary Outcome

Title	Number of Participants With a Subject's Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12
Description	An SGA of the facial skin, excluding the scalp, was performed by participants using a rating scale of 0 to 4: 0=face is basically free of acne, with only an occasional blackhead (Bh) and/or whitehead (Wh); 1=face has several Bhs and/or Whs and small pimples (P), but there are no tender deep-seated bumps or cysts (DSBCs); 2=face has several to many Bhs and/or Whs and small- to medium-sized P, and may have one DSBC; 3=face has many Bhs and/or Whs, many medium- to large-sized P, and perhaps a few DSBCs; 4=face has Bhs and/or Whs, and several to many medium- to large-sized Ps and DSBCs dominate.
Time Frame	Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Analysis Set

Arm/Group Title	Tazarotene Foam	Vehicle Foam
Arm/Group Description	Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.	The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Measure Participants	371	372
Week 2	104 28%	1 0.3%
Week 4	143 38.5%	130 34.9%
Week 8	187 50.4%	165 44.4%
Week 12	220 59.3%	180 48.4%

10. Secondary Outcome

Title	Change in Dermatology Life Quality Index (DLQI) Score From Baseline at Weeks 2, 4, 8, and 12 in Participants 17 Years of Age or Older
Description	The DLQI was used to measure how much the participants' skin problem had affected their life over the last week. The DLQI total score ranges from 0 to 30: 0-1=no effect at all on the participant's life; 2-5=small effect on the participant's life; 6-10=moderate effect on the participant's life; 11-20=very large effect on the participant's life; 21-30=extremely large effect on the participant's life. A lower score on the DLQI indicates increased quality of life; therefore, negative changes from Baseline indicate improvements.
Time Frame	Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Analysis Set: only those participants 17 years of age or older and whose DLQI scores were calculated at Baseline and at Weeks 2, 4, 8, or 12 were evaluated for change in DLQI score at the respective week.

Arm/Group Title	Tazarotene Foam	Vehicle Foam
Arm/Group Description	Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.	The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Measure Participants	171	165
Week 2, n=171,165	-0.1 (4.98)	-2.1 (3.68)
Week 4, n=166, 167	-1.9 (4.60)	-2.5 (3.85)
Week 8, n=160, 155	-2.9 (4.86)	-2.7 (4.40)
Week 12, n=154, 155	-3.6 (5.22)	-3.1 (4.31)

11. Secondary Outcome

Title	Change in Children's Dermatology Life Quality Index (CDLQI) From Baseline at Week 2, 4, 8 and 12 in Participant's With 16 Years Old or Younger
Description	The CDLQI was used to measure how much the participants' skin problem had affected their life over the last week. The CDLQI total score ranges from 0 to 30: 0-1=no effect at all on the participant's life; 2-6=small effect on the participant's life; 7-12=moderate effect on the participant's life; 13-18=very large effect on the participant's life; 19-30=extremely large effect on the participant's life. A lower score on the CDLQI indicates increased quality of life; therefore, negative changes from Baseline indicate improvements.
Time Frame	Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT Analysis Set: only those participants 16 years of age or younger and whose CDLQI scores were calculated at Baseline and at Weeks 2, 4, 8, or 12 were evaluated for change in DLQI score at the respective week.

Arm/Group Title	Tazarotene Foam	Vehicle Foam
Arm/Group Description	Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.	The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Measure Participants	162	179
Week 2, n=162,179	1.1 (4.16)	-1.4 (3.21)
Week 4, n=153, 180	-0.6 (3.45)	-1.4 (3.23)
Week 8, n=148, 171	-1.2 (3.53)	-1.9 (3.11)
Week 12, n=146, 169	-1.7 (4.09)	-2.0 (3.46)

12. Secondary Outcome

Title	Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator
Description	Erythema is a skin condition characterized by redness or rash. Local tolerability assessments were performed by the Investigator at each study visit and were graded based on severity as G0 to G4: G0=absent (no redness); G1=slight (faint red or pink coloration, barely perceptible); G2=mild (light red or pink coloration); G3=moderate (medium red coloration); G4=severe (beet red coloration). Maximum During Treatment is defined as the maximum severity of erythema reported at any time during treatment.
Time Frame	Baseline (Week 0/Day 1) to Week 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tazarotene Foam	Vehicle Foam
Arm/Group Description	Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.	The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Measure Participants	372	372
Baseline, G0	250 67.4%	242 65.1%
Baseline, G1	69 18.6%	99 26.6%
Baseline, G2	45 12.1%	24 6.5%
Baseline, G3	7 1.9%	7 1.9%
Baseline, G4	0 0%	0 0%
Baseline, Missing G	1 0.3%	0 0%
Maximum During Treatment (MDT), G0	81 21.8%	133 35.8%
MDT, G1	99 26.7%	152 40.9%
MDT, G2	115 31%	64 17.2%
MDT, G3	64 17.3%	13 3.5%
MDT, G4	3 0.8%	0 0%
MDT, Missing G	10 2.7%	10 2.7%
Week 12, G0	159 42.9%	216 58.1%
Week 12, G1	83 22.4%	87 23.4%
Week 12, G2	50 13.5%	24 6.5%
Week 12, G3	11 3%	3 0.8%
Week 12, G4	1 0.3%	0 0%
Week 12, Missing G	68 18.3%	42 11.3%

13. Secondary Outcome

Title	Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator
Description	Dryness: skin epidermis that lacks moisture/sebum. Local tolerability assessments were performed by the Investigator at each study visit and were graded based on severity as G0 to G4. G0=absent (none); G1=slight (barely perceptible dryness with no flakes or fissure formation); G2=mild (easily perceptible dryness with no flakes or fissure formation); G3=moderate (easily noted dryness and flakes but no fissure formation); G4=severe (easily noted dryness with flakes and fissure formation). Maximum During Treatment is defined as the maximum severity of drying reported at any time during treatment.
Time Frame	Baseline (Week 0/Day 1) to Week 12

Outcome Measure Data

Analysis Population Description

All Randomized Participants

Arm/Group Title	Tazarotene Foam	Vehicle Foam
Arm/Group Description	Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.	The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Measure Participants	372	372
Baseline, G0	329 88.7%	327 87.9%
Baseline, G1	34 9.2%	36 9.7%
Baseline, G2	6 1.6%	9 2.4%
Baseline, G3	2 0.5%	0 0%
Baseline, G4	0 0%	0 0%
Baseline, Missing G	1 0.3%	0 0%
MDT, G0	96 25.9%	222 59.7%
MDT, G1	101 27.2%	102 27.4%
MDT, G2	90 24.3%	36 9.7%
MDT, G3	72 19.4%	2 0.5%
MDT, G4	3 0.8%	0 0%
MDT, Missing G	10 2.7%	10 2.7%
Week 12, G0	208 56.1%	292 78.5%
Week 12, G1	67 18.1%	33 8.9%
Week 12, G2	22 5.9%	5 1.3%
Week 12, G3	7 1.9%	0 0%
Week 12, G4	0 0%	0 0%
Week 12, Missing G	68 18.3%	42 11.3%

14. Secondary Outcome

Title	Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator
Description	Peeling skin: damage to and loss of the upper layer of skin (epidermis). Local tolerability assessments for peeling were performed by the Investigator at each study visit and were graded based on severity as G0 to G4: G0=absent (no peeling); G1=slight (mild localized peeling); G2=mild (mild and diffuse peeling); G3=moderate (moderate and diffuse peeling); G4=severe (moderate to prominent, dense peeling). Maximum During Treatment is defined as the maximum severity of peeling reported at any time during treatment.
Time Frame	Baseline (Week 0/Day 1) to Week 12

Outcome Measure Data

Analysis Population Description

All Randomized Participants

Arm/Group Title	Tazarotene Foam	Vehicle Foam
Arm/Group Description	Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.	The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Measure Participants	372	372
Baseline, G0	344 92.7%	339 91.1%
Baseline, G1	22 5.9%	29 7.8%
Baseline, G2	5 1.3%	4 1.1%
Baseline, G3	0 0%	0 0%
Baseline, G4	0 0%	0 0%
Baseline, Missing G	1 0.3%	0 0%
MDT, G0	112 30.2%	256 68.8%
MDT, G1	104 28%	76 20.4%
MDT, G2	87 23.5%	28 7.5%
MDT, G3	51 13.7%	2 0.5%
MDT, G4	8 2.2%	0 0%
MDT, Missing G	10 2.7%	10 2.7%
Week 12, G0	221 59.6%	300 80.6%
Week 12, G1	57 15.4%	25 6.7%
Week 12, G2	16 4.3%	5 1.3%
Week 12, G3	10 2.7%	0 0%
Week 12, G4	0 0%	0 0%
Week 12, Missing G	68 18.3%	42 11.3%

15. Secondary Outcome

Title	Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants
Description	Itching is a sensation that causes the desire or reflex to scratch. Local tolerability assessments for itching were performed by the participant at each study visit and were graded based on severity as G0 to G3. G0=none; G1=slight; G2=moderate; G3=strong. Maximum During Treatment is defined as the maximum severity of itching reported at any time during treatment.
Time Frame	Baseline (Week 0/Day 1) to Week 12

Outcome Measure Data

Analysis Population Description

All Randomized Participants

Arm/Group Title	Tazarotene Foam	Vehicle Foam
Arm/Group Description	Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.	The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Measure Participants	372	372
Baseline, G0	237 63.9%	229 61.6%
Baseline, G1	104 28%	109 29.3%
Baseline, G2	26 7%	30 8.1%
Baseline, G3	3 0.8%	4 1.1%
Baseline, Missing G	2 0.5%	0 0%
MDT, G0	68 18.3%	126 33.9%
MDT, G1	164 44.2%	182 48.9%
MDT, G2	92 24.8%	48 12.9%
MDT, G3	38 10.2%	6 1.6%
MDT, Missing G	10 2.7%	10 2.7%
Week 12, G0	174 46.9%	216 58.1%
Week 12, G1	111 29.9%	96 25.8%
Week 12, G2	17 4.6%	16 4.3%
Week 12, G3	2 0.5%	2 0.5%
Week 12, Missing G	68 18.3%	42 11.3%

16. Secondary Outcome

Title	Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants
Description	Burning/stinging is a pain and burning sensation. Local tolerability assessments were performed by the participant at each study visit based on severity as G0 to G3: G0=none; G1=slight; G2=moderate; G3=strong. Maximum During Treatment is defined as the maximum severity of burning/stinging reported at any time during treatment.
Time Frame	Baseline (Week 0/Day 1) to Week 12

Outcome Measure Data

Analysis Population Description

All Randomized Participants

Arm/Group Title	Tazarotene Foam	Vehicle Foam
Arm/Group Description	Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.	The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Measure Participants	372	372
Baseline, G0	307 82.7%	291 78.2%
Baseline, G1	34 9.2%	64 17.2%
Baseline, G2	26 7%	15 4%
Baseline, G3	3 0.8%	2 0.5%
Baseline, Missing G	2 0.5%	0 0%
MDT, G0	52 14%	137 36.8%
MDT, G1	101 27.2%	159 42.7%
MDT, G2	122 32.9%	55 14.8%
MDT, G3	87 23.5%	11 3%
MDT, Missing G	10 2.7%	10 2.7%
Week 12, G0	179 48.2%	222 59.7%
Week 12, G1	94 25.3%	94 25.3%
Week 12, G2	24 6.5%	13 3.5%
Week 12, G3	7 1.9%	1 0.3%
Week 12, Missing G	68 18.3%	42 11.3%

Adverse Events

Arm/Group Title	Tazarotene Foam		Vehicle Foam
Arm/Group Description	Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.		The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
All Cause Mortality
	Tazarotene Foam		Vehicle Foam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Tazarotene Foam		Vehicle Foam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/371 (0.3%)		1/372 (0.3%)
Injury, poisoning and procedural complications
Brain contusion	0/371 (0%)		1/372 (0.3%)
Nervous system disorders
Intracranial pressure increased	0/371 (0%)		1/372 (0.3%)
Psychiatric disorders
Adjustment disorder with mixed disturbance of emotion, condu	1/371 (0.3%)		0/372 (0%)
Depression	1/371 (0.3%)		0/372 (0%)
Other (Not Including Serious) Adverse Events
	Tazarotene Foam		Vehicle Foam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	88/371 (23.7%)		17/372 (4.6%)
General disorders
Application Site Dryness	22/371 (5.9%)		2/372 (0.5%)
Application Site Irritation	66/371 (17.8%)		15/372 (4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.