Acne Vulgaris
Conditions
Keywords
Ance
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.
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.
Interventions
DRUGTazarotene foam
Tazarotene foam once a day application to the face
DRUGVehicle Foam
Vehicle Foam once a day application to the face
Sponsors
GlaxoSmithKline
Stiefel, a GSK Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 371 |
| 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. | 372 |
| Total | 743 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 11 | 1 |
| Overall Study | Change in Work Situation | 1 | 0 |
| Overall Study | Did Not Meet Eligibility Criteria | 1 | 2 |
| Overall Study | Lost to Follow-up | 14 | 14 |
| Overall Study | Noncompliance with Study Product | 1 | 1 |
| Overall Study | Pregnancy | 2 | 1 |
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | Relocation | 0 | 4 |
| Overall Study | Took Excluded Medication | 2 | 0 |
| Overall Study | Withdrawal by Subject | 32 | 16 |
Baseline characteristics
| Characteristic | Vehicle Foam | Tazarotene Foam | Total |
|---|---|---|---|
| Age, Continuous Years | 18.6 Years STANDARD_DEVIATION 6.4 | 18.2 Years STANDARD_DEVIATION 5.7 | 18.4 Years STANDARD_DEVIATION 6.1 |
| Gender Female | 192 Participants | 182 Participants | 374 Participants |
| Gender Male | 180 Participants | 189 Participants | 369 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 3 participants | 12 participants | 15 participants |
| Race/Ethnicity, Customized Asian | 4 participants | 11 participants | 15 participants |
| Race/Ethnicity, Customized Black | 50 participants | 53 participants | 103 participants |
| Race/Ethnicity, Customized Mixed Race | 7 participants | 10 participants | 17 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White | 307 participants | 285 participants | 592 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 88 / 371 | 17 / 372 |
| serious Total, serious adverse events | 1 / 371 | 1 / 372 |
Outcome results
Primary
Absolute Change in Lesion Counts (LCs) From Baseline to 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tazarotene Foam | Absolute Change in Lesion Counts (LCs) From Baseline to Week 12 | ILs | -18.0 lesion counts | Standard Deviation 11.01 |
| Tazarotene Foam | Absolute Change in Lesion Counts (LCs) From Baseline to Week 12 | NILs | -27.9 lesion counts | Standard Deviation 21.65 |
| Tazarotene Foam | Absolute Change in Lesion Counts (LCs) From Baseline to Week 12 | TLs | -45.8 lesion counts | Standard Deviation 27.89 |
| Vehicle Foam | Absolute Change in Lesion Counts (LCs) From Baseline to Week 12 | ILs | -14.1 lesion counts | Standard Deviation 12.37 |
| Vehicle Foam | Absolute Change in Lesion Counts (LCs) From Baseline to Week 12 | NILs | -16.7 lesion counts | Standard Deviation 21.72 |
| Vehicle Foam | Absolute Change in Lesion Counts (LCs) From Baseline to Week 12 | TLs | -30.8 lesion counts | Standard Deviation 26.68 |
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
Primary
Number of Participants With a Minimum 2-grade (G) Improvement in the Investigator Static Global Assessment (ISGA) Score From Baseline at 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.
Time frame: Baseline (Week 0/Day 1) and Week 12
Population: ITT Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tazarotene Foam | Number of Participants With a Minimum 2-grade (G) Improvement in the Investigator Static Global Assessment (ISGA) Score From Baseline at Week 12 | 132 participants |
| Vehicle Foam | Number of Participants With a Minimum 2-grade (G) Improvement in the Investigator Static Global Assessment (ISGA) Score From Baseline at Week 12 | 89 participants |
p-value: <0.00195% CI: [30.7, 40.5]Cochran-Mantel-Haenszel
95% CI: [19.6, 28.3]
Primary
Number of Participants With an ISGA Score of 0 or 1 at 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.
Time frame: Week 12
Population: ITT Analysis Set. Missing values were imputed using the LOCF method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tazarotene Foam | Number of Participants With an ISGA Score of 0 or 1 at Week 12 | 107 participants |
| Vehicle Foam | Number of Participants With an ISGA Score of 0 or 1 at Week 12 | 60 participants |
p-value: <0.00195% CI: [24.2, 33.5]Cochran-Mantel-Haenszel
95% CI: [12.4, 19.9]
Secondary
Absolute Change From Baseline in LC at 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tazarotene Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | ILs, Week 4 | -10.1 lesion counts | Standard Deviation 10.44 |
| Tazarotene Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | NILs, Week 8 | -24.6 lesion counts | Standard Deviation 19.64 |
| Tazarotene Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | NILs, Week 2 | -12.6 lesion counts | Standard Deviation 15.72 |
| Tazarotene Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | TLs, Week 2 | -18.1 lesion counts | Standard Deviation 20.22 |
| Tazarotene Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | ILs, Week 8 | -15.6 lesion counts | Standard Deviation 10.4 |
| Tazarotene Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | TLs, Week 4 | -28.3 lesion counts | Standard Deviation 22.77 |
| Tazarotene Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | NILs, Week 4 | -18.2 lesion counts | Standard Deviation 17.7 |
| Tazarotene Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | TLs, Week 8 | -40.1 lesion counts | Standard Deviation 24.67 |
| Tazarotene Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | ILs, Week 2 | -5.5 lesion counts | Standard Deviation 11.54 |
| Vehicle Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | TLs, Week 8 | -27.9 lesion counts | Standard Deviation 28.09 |
| Vehicle Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | ILs, Week 2 | -6.5 lesion counts | Standard Deviation 11.98 |
| Vehicle Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | ILs, Week 4 | -10.9 lesion counts | Standard Deviation 11.74 |
| Vehicle Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | ILs, Week 8 | -13.2 lesion counts | Standard Deviation 12.71 |
| Vehicle Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | NILs, Week 2 | -8.6 lesion counts | Standard Deviation 16.22 |
| Vehicle Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | NILs, Week 4 | -12.2 lesion counts | Standard Deviation 18.41 |
| Vehicle Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | NILs, Week 8 | -14.8 lesion counts | Standard Deviation 21.63 |
| Vehicle Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | TLs, Week 2 | -15.1 lesion counts | Standard Deviation 18.8 |
| Vehicle Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | TLs, Week 4 | -23.1 lesion counts | Standard Deviation 23.3 |
Secondary
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
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
Population: ITT Analysis Set: only those participants 16 years of age or younger and whose CDLQI scores were calculated at Baseline and at Weeks 2, 4, 8, or 12 were evaluated for change in DLQI score at the respective week.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tazarotene Foam | Change in Children's Dermatology Life Quality Index (CDLQI) From Baseline at Week 2, 4, 8 and 12 in Participant's With 16 Years Old or Younger | Week 2, n=162,179 | 1.1 scores on a scale | Standard Deviation 4.16 |
| Tazarotene Foam | Change in Children's Dermatology Life Quality Index (CDLQI) From Baseline at Week 2, 4, 8 and 12 in Participant's With 16 Years Old or Younger | Week 4, n=153, 180 | -0.6 scores on a scale | Standard Deviation 3.45 |
| Tazarotene Foam | Change in Children's Dermatology Life Quality Index (CDLQI) From Baseline at Week 2, 4, 8 and 12 in Participant's With 16 Years Old or Younger | Week 8, n=148, 171 | -1.2 scores on a scale | Standard Deviation 3.53 |
| Tazarotene Foam | Change in Children's Dermatology Life Quality Index (CDLQI) From Baseline at Week 2, 4, 8 and 12 in Participant's With 16 Years Old or Younger | Week 12, n=146, 169 | -1.7 scores on a scale | Standard Deviation 4.09 |
| Vehicle Foam | Change in Children's Dermatology Life Quality Index (CDLQI) From Baseline at Week 2, 4, 8 and 12 in Participant's With 16 Years Old or Younger | Week 12, n=146, 169 | -2.0 scores on a scale | Standard Deviation 3.46 |
| Vehicle Foam | Change in Children's Dermatology Life Quality Index (CDLQI) From Baseline at Week 2, 4, 8 and 12 in Participant's With 16 Years Old or Younger | Week 2, n=162,179 | -1.4 scores on a scale | Standard Deviation 3.21 |
| Vehicle Foam | Change in Children's Dermatology Life Quality Index (CDLQI) From Baseline at Week 2, 4, 8 and 12 in Participant's With 16 Years Old or Younger | Week 8, n=148, 171 | -1.9 scores on a scale | Standard Deviation 3.11 |
| Vehicle Foam | Change in Children's Dermatology Life Quality Index (CDLQI) From Baseline at Week 2, 4, 8 and 12 in Participant's With 16 Years Old or Younger | Week 4, n=153, 180 | -1.4 scores on a scale | Standard Deviation 3.23 |
Secondary
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
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
Population: ITT Analysis Set: only those participants 17 years of age or older and whose DLQI scores were calculated at Baseline and at Weeks 2, 4, 8, or 12 were evaluated for change in DLQI score at the respective week.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tazarotene Foam | Change in Dermatology Life Quality Index (DLQI) Score From Baseline at Weeks 2, 4, 8, and 12 in Participants 17 Years of Age or Older | Week 2, n=171,165 | -0.1 Scores on a scale | Standard Deviation 4.98 |
| Tazarotene Foam | Change in Dermatology Life Quality Index (DLQI) Score From Baseline at Weeks 2, 4, 8, and 12 in Participants 17 Years of Age or Older | Week 4, n=166, 167 | -1.9 Scores on a scale | Standard Deviation 4.6 |
| Tazarotene Foam | Change in Dermatology Life Quality Index (DLQI) Score From Baseline at Weeks 2, 4, 8, and 12 in Participants 17 Years of Age or Older | Week 8, n=160, 155 | -2.9 Scores on a scale | Standard Deviation 4.86 |
| Tazarotene Foam | Change in Dermatology Life Quality Index (DLQI) Score From Baseline at Weeks 2, 4, 8, and 12 in Participants 17 Years of Age or Older | Week 12, n=154, 155 | -3.6 Scores on a scale | Standard Deviation 5.22 |
| Vehicle Foam | Change in Dermatology Life Quality Index (DLQI) Score From Baseline at Weeks 2, 4, 8, and 12 in Participants 17 Years of Age or Older | Week 12, n=154, 155 | -3.1 Scores on a scale | Standard Deviation 4.31 |
| Vehicle Foam | Change in Dermatology Life Quality Index (DLQI) Score From Baseline at Weeks 2, 4, 8, and 12 in Participants 17 Years of Age or Older | Week 2, n=171,165 | -2.1 Scores on a scale | Standard Deviation 3.68 |
| Vehicle Foam | Change in Dermatology Life Quality Index (DLQI) Score From Baseline at Weeks 2, 4, 8, and 12 in Participants 17 Years of Age or Older | Week 8, n=160, 155 | -2.7 Scores on a scale | Standard Deviation 4.4 |
| Vehicle Foam | Change in Dermatology Life Quality Index (DLQI) Score From Baseline at Weeks 2, 4, 8, and 12 in Participants 17 Years of Age or Older | Week 4, n=166, 167 | -2.5 Scores on a scale | Standard Deviation 3.85 |
Secondary
Number of Participants With a Minimum 2-grade Improvement in ISGA Score at 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.
Time frame: Baseline (Week 0/Day 1); Weeks 2, 4, and 8
Population: ITT Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tazarotene Foam | Number of Participants With a Minimum 2-grade Improvement in ISGA Score at Weeks 2, 4, and 8 | Week 2 | 10 participants |
| Tazarotene Foam | Number of Participants With a Minimum 2-grade Improvement in ISGA Score at Weeks 2, 4, and 8 | Week 4 | 23 participants |
| Tazarotene Foam | Number of Participants With a Minimum 2-grade Improvement in ISGA Score at Weeks 2, 4, and 8 | Week 8 | 64 participants |
| Vehicle Foam | Number of Participants With a Minimum 2-grade Improvement in ISGA Score at Weeks 2, 4, and 8 | Week 2 | 11 participants |
| Vehicle Foam | Number of Participants With a Minimum 2-grade Improvement in ISGA Score at Weeks 2, 4, and 8 | Week 4 | 29 participants |
| Vehicle Foam | Number of Participants With a Minimum 2-grade Improvement in ISGA Score at Weeks 2, 4, and 8 | Week 8 | 44 participants |
Secondary
Number of Participants With an ISGA Score of 0 or 1 at 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.
Time frame: Weeks 2, 4, and 8
Population: ITT Analysis Set. Missing values were imputed using the LOCF method.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tazarotene Foam | Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8 | Week 2 | 4 participants |
| Tazarotene Foam | Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8 | Week 4 | 12 participants |
| Tazarotene Foam | Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8 | Week 8 | 40 participants |
| Vehicle Foam | Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8 | Week 2 | 1 participants |
| Vehicle Foam | Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8 | Week 4 | 7 participants |
| Vehicle Foam | Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8 | Week 8 | 22 participants |
Secondary
Number of Participants With a Subject's Global Assessment (SGA) Score of 0 or 1 at 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.
Time frame: Weeks 2, 4, 8, and 12
Population: ITT Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tazarotene Foam | Number of Participants With a Subject's Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12 | Week 2 | 104 participants |
| Tazarotene Foam | Number of Participants With a Subject's Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12 | Week 4 | 143 participants |
| Tazarotene Foam | Number of Participants With a Subject's Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12 | Week 8 | 187 participants |
| Tazarotene Foam | Number of Participants With a Subject's Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12 | Week 12 | 220 participants |
| Vehicle Foam | Number of Participants With a Subject's Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12 | Week 12 | 180 participants |
| Vehicle Foam | Number of Participants With a Subject's Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12 | Week 2 | 1 participants |
| Vehicle Foam | Number of Participants With a Subject's Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12 | Week 8 | 165 participants |
| Vehicle Foam | Number of Participants With a Subject's Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12 | Week 4 | 130 participants |
Secondary
Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the 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.
Time frame: Baseline (Week 0/Day 1) to Week 12
Population: All Randomized Participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Week 12, G2 | 24 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Baseline, G0 | 307 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Baseline, G1 | 34 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Baseline, G2 | 26 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Baseline, G3 | 3 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Baseline, Missing G | 2 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | MDT, G0 | 52 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | MDT, G1 | 101 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | MDT, G2 | 122 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | MDT, G3 | 87 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | MDT, Missing G | 10 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Week 12, G0 | 179 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Week 12, G1 | 94 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Week 12, G3 | 7 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Week 12, Missing G | 68 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Week 12, G3 | 1 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | MDT, G2 | 55 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Baseline, G0 | 291 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Week 12, G1 | 94 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Baseline, G1 | 64 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | MDT, G3 | 11 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Baseline, G2 | 15 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Week 12, G2 | 13 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Baseline, G3 | 2 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | MDT, Missing G | 10 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Baseline, Missing G | 0 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Week 12, Missing G | 42 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | MDT, G0 | 137 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Week 12, G0 | 222 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | MDT, G1 | 159 participants |
Secondary
Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator
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
Population: All Randomized Participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Baseline, G0 | 329 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Baseline, G1 | 34 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Baseline, G2 | 6 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Baseline, G3 | 2 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Baseline, G4 | 0 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Baseline, Missing G | 1 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | MDT, G0 | 96 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | MDT, G1 | 101 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | MDT, G2 | 90 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | MDT, G3 | 72 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | MDT, G4 | 3 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | MDT, Missing G | 10 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Week 12, G0 | 208 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Week 12, G1 | 67 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Week 12, G2 | 22 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Week 12, G3 | 7 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Week 12, G4 | 0 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Week 12, Missing G | 68 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Week 12, G1 | 33 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Baseline, G0 | 327 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | MDT, G3 | 2 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Baseline, G1 | 36 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Week 12, Missing G | 42 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Baseline, G2 | 9 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | MDT, G4 | 0 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Baseline, G3 | 0 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Week 12, G2 | 5 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Baseline, G4 | 0 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | MDT, Missing G | 10 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Baseline, Missing G | 0 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Week 12, G4 | 0 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | MDT, G0 | 222 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Week 12, G0 | 292 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | MDT, G1 | 102 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Week 12, G3 | 0 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | MDT, G2 | 36 participants |
Secondary
Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator
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
Population: All Randomized Participants: all participants who were randomized in the study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | MDT, G4 | 3 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Baseline, G0 | 250 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Baseline, G1 | 69 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Baseline, G2 | 45 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Baseline, G3 | 7 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Baseline, G4 | 0 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Baseline, Missing G | 1 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Maximum During Treatment (MDT), G0 | 81 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | MDT, Missing G | 10 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | MDT, G1 | 99 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Week 12, G0 | 159 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | MDT, G2 | 115 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | MDT, G3 | 64 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Week 12, G1 | 83 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Week 12, G2 | 50 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Week 12, G3 | 11 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Week 12, G4 | 1 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Week 12, Missing G | 68 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Week 12, Missing G | 42 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | MDT, G3 | 13 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Baseline, G0 | 242 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | MDT, G1 | 152 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Baseline, G1 | 99 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Week 12, G2 | 24 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Baseline, G2 | 24 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | MDT, G2 | 64 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Baseline, G3 | 7 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Week 12, G4 | 0 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Baseline, G4 | 0 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Week 12, G0 | 216 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Baseline, Missing G | 0 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Week 12, G3 | 3 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | MDT, G4 | 0 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Week 12, G1 | 87 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Maximum During Treatment (MDT), G0 | 133 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | MDT, Missing G | 10 participants |
Secondary
Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the 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.
Time frame: Baseline (Week 0/Day 1) to Week 12
Population: All Randomized Participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Baseline, Missing G | 2 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | MDT, G3 | 38 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Baseline, G1 | 104 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | MDT, Missing G | 10 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | MDT, G0 | 68 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Week 12, G0 | 174 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Baseline, G3 | 3 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Week 12, G1 | 111 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | MDT, G1 | 164 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Week 12, G2 | 17 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Baseline, G2 | 26 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Week 12, G3 | 2 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | MDT, G2 | 92 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Week 12, Missing G | 68 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Baseline, G0 | 237 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Week 12, Missing G | 42 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Baseline, G0 | 229 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Baseline, G1 | 109 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Baseline, G2 | 30 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Baseline, G3 | 4 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Baseline, Missing G | 0 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | MDT, G0 | 126 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | MDT, G1 | 182 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | MDT, G2 | 48 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | MDT, G3 | 6 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | MDT, Missing G | 10 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Week 12, G0 | 216 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Week 12, G1 | 96 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Week 12, G2 | 16 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Week 12, G3 | 2 participants |
Secondary
Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator
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
Population: All Randomized Participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Baseline, G0 | 344 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Baseline, G1 | 22 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Baseline, G2 | 5 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Baseline, G3 | 0 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Baseline, G4 | 0 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Baseline, Missing G | 1 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | MDT, G0 | 112 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | MDT, G1 | 104 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | MDT, G2 | 87 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | MDT, G3 | 51 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | MDT, G4 | 8 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | MDT, Missing G | 10 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Week 12, G0 | 221 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Week 12, G1 | 57 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Week 12, G2 | 16 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Week 12, G3 | 10 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Week 12, G4 | 0 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Week 12, Missing G | 68 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Week 12, G1 | 25 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Baseline, G0 | 339 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | MDT, G3 | 2 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Baseline, G1 | 29 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Week 12, Missing G | 42 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Baseline, G2 | 4 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | MDT, G4 | 0 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Baseline, G3 | 0 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Week 12, G2 | 5 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Baseline, G4 | 0 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | MDT, Missing G | 10 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Baseline, Missing G | 0 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Week 12, G4 | 0 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | MDT, G0 | 256 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Week 12, G0 | 300 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | MDT, G1 | 76 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Week 12, G3 | 0 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | MDT, G2 | 28 participants |
Secondary
Percent Change in LC From Baseline at 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.
Time frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
Population: ITT Analysis Set. The LOCF imputation method was used for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tazarotene Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | ILs, Week 2 | -18.2 percent change | Standard Deviation 35.84 |
| Tazarotene Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | ILs, Week 4 | -33.0 percent change | Standard Deviation 32.75 |
| Tazarotene Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | ILs, Week 8 | -50.1 percent change | Standard Deviation 31.53 |
| Tazarotene Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | ILs, Week 12 | -57.5 percent change | Standard Deviation 33.39 |
| Tazarotene Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | NILs, Week 2 | -24.5 percent change | Standard Deviation 26.21 |
| Tazarotene Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | NILs, Week 4 | -36.6 percent change | Standard Deviation 28.59 |
| Tazarotene Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | NILs, Week 8 | -48.7 percent change | Standard Deviation 29.2 |
| Tazarotene Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | NILs, Week 12 | -55.1 percent change | Standard Deviation 30.88 |
| Tazarotene Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | TLs, Week 2 | -22.5 percent change | Standard Deviation 23.39 |
| Tazarotene Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | TLs, Week 4 | -35.3 percent change | Standard Deviation 25.41 |
| Tazarotene Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | TLs, Week 8 | -49.5 percent change | Standard Deviation 26.2 |
| Tazarotene Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | TLs, Week 12 | -56.3 percent change | Standard Deviation 28.52 |
| Vehicle Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | TLs, Week 8 | -35.6 percent change | Standard Deviation 31.16 |
| Vehicle Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | ILs, Week 2 | -20.9 percent change | Standard Deviation 33.64 |
| Vehicle Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | NILs, Week 8 | -30.6 percent change | Standard Deviation 36.64 |
| Vehicle Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | ILs, Week 4 | -24.8 percent change | Standard Deviation 34.42 |
| Vehicle Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | TLs, Week 4 | -29.3 percent change | Standard Deviation 26.98 |
| Vehicle Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | ILs, Week 8 | -42.1 percent change | Standard Deviation 38.62 |
| Vehicle Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | NILs, Week 12 | -34.3 percent change | Standard Deviation 42.56 |
| Vehicle Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | ILs, Week 12 | -45.2 percent change | Standard Deviation 38.64 |
| Vehicle Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | TLs, Week 12 | -39.0 percent change | Standard Deviation 34.4 |
| Vehicle Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | NILs, Week 2 | -16.6 percent change | Standard Deviation 28.64 |
| Vehicle Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | TLs, Week 2 | -18.8 percent change | Standard Deviation 22.21 |
| Vehicle Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | NILs, Week 4 | -25.0 percent change | Standard Deviation 32.45 |
Secondary
Time to a 50 Percent Reduction in Total Lesion Counts (TLC)
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
Population: ITT Analysis Set: only those participants with a \>=50 percent reduction from Baseline in TLC were evaluated.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tazarotene Foam | Time to a 50 Percent Reduction in Total Lesion Counts (TLC) | 57 days |
| Vehicle Foam | Time to a 50 Percent Reduction in Total Lesion Counts (TLC) | 85 days |