Acne Vulgaris
Conditions
Keywords
Acne
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 G 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. |
| Number of Participants With a 2-G Improvement in ISGA Score and an ISGA Score of 0 or 1 at Weeks 2, 4, 8, and 12 | Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 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. |
| Absolute Change in Papule Count From Baseline at Weeks 2, 4, 8, and 12 | Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 | A papule is a circumscribed, solid elevation of the skin with no visible fluid. Change from basline in papule count at Weeks 2, 4, 8, and 12 was calculated as the papule count at Week 2/4/8/12 minus the papule count at Baseline. |
| Absolute Change in Pustule Count From Baseline at Weeks 2, 4, 8, and 12 | Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 | A pustule is a small elevation of the skin containing cloudy or purulent material usually consisting of necrotic inflammatory cells. Change from basline in pustule count at Weeks 2, 4, 8, and 12 was calculated as the pustule count at Week 2/4/8/12 minus the pustule count at Baseline. |
| Absolute Change in Nodule Count From Baseline at Weeks 2, 4, 8, and 12 | Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 | A nodule is a slightly elevated lesion on or in the skin. Change from basline in nodule count at Weeks 2, 4, 8, and 12 was calculated as the nodule count at Week 2/4/8/12 value (s) minus the nodule count at Baseline. |
| Absolute Change in Open Comedone Count From Baseline at Weeks 2, 4, 8, and 12 | Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 | An open comedone is a yellow or blackish bump or plug on the skin. Change from Baseline in open comedone count at Weeks 2, 4, 8, and 12 was calculated as the open comedone count at Week 2/4/8/12 minus the open comedone count at Baseline. |
| 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. |
| 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); Week 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. |
| 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. |
| 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 dryness 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. |
| Absolute Change in Closed Comedone Count From Baseline at Weeks 2, 4, 8, and 12 | Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 | A closed comedone is a whitehead. Change from basline in closed comedone count at Weeks 2, 4, 8, and 12 was calculated as the closed comedone count at Week 2/4/8/12 minus the closed comedone count at Baseline. |
| 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. | 373 |
| 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. | 369 |
| Total | 742 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 9 | 0 |
| Overall Study | Did Not Meet Eligibility Criteria | 1 | 0 |
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | Lost to Follow-up | 13 | 11 |
| Overall Study | Parent Unable to Provide Transportation | 1 | 0 |
| Overall Study | Pregnancy | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Relocated Out of Town | 0 | 2 |
| Overall Study | Withdrawal by Subject | 39 | 21 |
Baseline characteristics
| Characteristic | Vehicle Foam | Total | Tazarotene Foam |
|---|---|---|---|
| Age, Continuous | 19.2 Years STANDARD_DEVIATION 6.8 | 19.2 Years STANDARD_DEVIATION 6.6 | 19.2 Years STANDARD_DEVIATION 6.5 |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 2 participants | 4 participants | 2 participants |
| Race/Ethnicity, Customized Asian | 21 participants | 49 participants | 28 participants |
| Race/Ethnicity, Customized Black | 57 participants | 117 participants | 60 participants |
| Race/Ethnicity, Customized Mixed Race | 5 participants | 10 participants | 5 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 4 participants | 4 participants | 0 participants |
| Race/Ethnicity, Customized White | 280 participants | 558 participants | 278 participants |
| Sex: Female, Male Female | 185 Participants | 382 Participants | 197 Participants |
| Sex: Female, Male Male | 184 Participants | 360 Participants | 176 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 69 / 373 | 10 / 369 |
| serious Total, serious adverse events | 1 / 373 | 0 / 369 |
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 | -17.8 lesion counts | Standard Deviation 11.81 |
| Tazarotene Foam | Absolute Change in Lesion Counts (LCs) From Baseline to Week 12 | NILs | -25.6 lesion counts | Standard Deviation 17.06 |
| Tazarotene Foam | Absolute Change in Lesion Counts (LCs) From Baseline to Week 12 | TLs | -43.4 lesion counts | Standard Deviation 24.27 |
| Vehicle Foam | Absolute Change in Lesion Counts (LCs) From Baseline to Week 12 | TLs | -32.9 lesion counts | Standard Deviation 21.99 |
| Vehicle Foam | Absolute Change in Lesion Counts (LCs) From Baseline to Week 12 | ILs | -14.7 lesion counts | Standard Deviation 10.66 |
| Vehicle Foam | Absolute Change in Lesion Counts (LCs) From Baseline to Week 12 | NILs | -18.2 lesion counts | Standard Deviation 15.21 |
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 | 120 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 | 67 participants |
p-value: <0.00195% CI: [27.4, 36.9]Cochran-Mantel-Haenszel
95% CI: [14.2, 22.1]
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 | 103 participants |
| Vehicle Foam | Number of Participants With an ISGA Score of 0 or 1 at Week 12 | 49 participants |
p-value: <0.00195% CI: [23.1, 32.2]Cochran-Mantel-Haenszel
95% CI: [9.8, 16.7]
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 | NILs, Week 4 | -17.3 lesion counts | Standard Deviation 13.73 |
| Tazarotene Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | ILs, Week 8 | -15.7 lesion counts | Standard Deviation 11.06 |
| Tazarotene Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | NILs, Week 8 | -22.6 lesion counts | Standard Deviation 15.42 |
| Tazarotene Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | TLs, Week 2 | -16.6 lesion counts | Standard Deviation 17.15 |
| Tazarotene Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | ILs, Week 4 | -10.7 lesion counts | Standard Deviation 10.41 |
| Tazarotene Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | TLs, Week 4 | -28.0 lesion counts | Standard Deviation 18.85 |
| Tazarotene Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | NILs, Week 2 | -10.7 lesion counts | Standard Deviation 13.37 |
| Tazarotene Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | TLs, Week 8 | -38.3 lesion counts | Standard Deviation 21.49 |
| Tazarotene Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | ILs, Week 2 | -5.9 lesion counts | Standard Deviation 8.87 |
| Vehicle Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | TLs, Week 8 | -29.7 lesion counts | Standard Deviation 20.42 |
| Vehicle Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | ILs, Week 2 | -5.6 lesion counts | Standard Deviation 8.8 |
| Vehicle Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | ILs, Week 4 | -10.2 lesion counts | Standard Deviation 9.95 |
| Vehicle Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | ILs, Week 8 | -13.3 lesion counts | Standard Deviation 9.77 |
| Vehicle Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | NILs, Week 2 | -7.7 lesion counts | Standard Deviation 12.5 |
| Vehicle Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | NILs, Week 4 | -11.8 lesion counts | Standard Deviation 14.37 |
| Vehicle Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | TLs, Week 2 | -13.3 lesion counts | Standard Deviation 17.5 |
| Vehicle Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | TLs, Week 4 | -22.0 lesion counts | Standard Deviation 19.39 |
| Vehicle Foam | Absolute Change From Baseline in LC at Weeks 2, 4, and 8 | NILs, Week 8 | -16.5 lesion counts | Standard Deviation 14.26 |
Secondary
Absolute Change in Closed Comedone Count From Baseline at Weeks 2, 4, 8, and 12
A closed comedone is a whitehead. Change from basline in closed comedone count at Weeks 2, 4, 8, and 12 was calculated as the closed comedone count at Week 2/4/8/12 minus the closed comedone count at Baseline.
Time frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
Population: ITT Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tazarotene Foam | Absolute Change in Closed Comedone Count From Baseline at Weeks 2, 4, 8, and 12 | Week 4 | -11.5 closed comedone count | Standard Deviation 12.56 |
| Tazarotene Foam | Absolute Change in Closed Comedone Count From Baseline at Weeks 2, 4, 8, and 12 | Week 2 | -7.3 closed comedone count | Standard Deviation 10.84 |
| Tazarotene Foam | Absolute Change in Closed Comedone Count From Baseline at Weeks 2, 4, 8, and 12 | Week 8 | -15.3 closed comedone count | Standard Deviation 14.1 |
| Tazarotene Foam | Absolute Change in Closed Comedone Count From Baseline at Weeks 2, 4, 8, and 12 | Week 12 | -17.2 closed comedone count | Standard Deviation 14.66 |
| Vehicle Foam | Absolute Change in Closed Comedone Count From Baseline at Weeks 2, 4, 8, and 12 | Week 12 | -11.4 closed comedone count | Standard Deviation 13.96 |
| Vehicle Foam | Absolute Change in Closed Comedone Count From Baseline at Weeks 2, 4, 8, and 12 | Week 2 | -4.5 closed comedone count | Standard Deviation 10.52 |
| Vehicle Foam | Absolute Change in Closed Comedone Count From Baseline at Weeks 2, 4, 8, and 12 | Week 4 | -7.6 closed comedone count | Standard Deviation 11.55 |
| Vehicle Foam | Absolute Change in Closed Comedone Count From Baseline at Weeks 2, 4, 8, and 12 | Week 8 | -10.7 closed comedone count | Standard Deviation 11.98 |
Secondary
Absolute Change in Nodule Count From Baseline at Weeks 2, 4, 8, and 12
A nodule is a slightly elevated lesion on or in the skin. Change from basline in nodule count at Weeks 2, 4, 8, and 12 was calculated as the nodule count at Week 2/4/8/12 value (s) minus the nodule count at Baseline.
Time frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
Population: ITT Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tazarotene Foam | Absolute Change in Nodule Count From Baseline at Weeks 2, 4, 8, and 12 | Week 2 | -0.0 nodule count | Standard Deviation 0.35 |
| Tazarotene Foam | Absolute Change in Nodule Count From Baseline at Weeks 2, 4, 8, and 12 | Week 4 | -0.0 nodule count | Standard Deviation 0.4 |
| Tazarotene Foam | Absolute Change in Nodule Count From Baseline at Weeks 2, 4, 8, and 12 | Week 8 | -0.0 nodule count | Standard Deviation 0.4 |
| Tazarotene Foam | Absolute Change in Nodule Count From Baseline at Weeks 2, 4, 8, and 12 | Week 12 | -0.0 nodule count | Standard Deviation 0.35 |
| Vehicle Foam | Absolute Change in Nodule Count From Baseline at Weeks 2, 4, 8, and 12 | Week 12 | 0.0 nodule count | Standard Deviation 0.78 |
| Vehicle Foam | Absolute Change in Nodule Count From Baseline at Weeks 2, 4, 8, and 12 | Week 2 | 0.0 nodule count | Standard Deviation 0.72 |
| Vehicle Foam | Absolute Change in Nodule Count From Baseline at Weeks 2, 4, 8, and 12 | Week 8 | 0.1 nodule count | Standard Deviation 0.83 |
| Vehicle Foam | Absolute Change in Nodule Count From Baseline at Weeks 2, 4, 8, and 12 | Week 4 | 0.0 nodule count | Standard Deviation 0.8 |
Secondary
Absolute Change in Open Comedone Count From Baseline at Weeks 2, 4, 8, and 12
An open comedone is a yellow or blackish bump or plug on the skin. Change from Baseline in open comedone count at Weeks 2, 4, 8, and 12 was calculated as the open comedone count at Week 2/4/8/12 minus the open comedone count at Baseline.
Time frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
Population: ITT Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tazarotene Foam | Absolute Change in Open Comedone Count From Baseline at Weeks 2, 4, 8, and 12 | Week 2 | -3.5 open comedone count | Standard Deviation 8.49 |
| Tazarotene Foam | Absolute Change in Open Comedone Count From Baseline at Weeks 2, 4, 8, and 12 | Week 4 | -5.8 open comedone count | Standard Deviation 9.19 |
| Tazarotene Foam | Absolute Change in Open Comedone Count From Baseline at Weeks 2, 4, 8, and 12 | Week 8 | -7.3 open comedone count | Standard Deviation 10.13 |
| Tazarotene Foam | Absolute Change in Open Comedone Count From Baseline at Weeks 2, 4, 8, and 12 | Week 12 | -8.4 open comedone count | Standard Deviation 10.9 |
| Vehicle Foam | Absolute Change in Open Comedone Count From Baseline at Weeks 2, 4, 8, and 12 | Week 12 | -6.9 open comedone count | Standard Deviation 9.56 |
| Vehicle Foam | Absolute Change in Open Comedone Count From Baseline at Weeks 2, 4, 8, and 12 | Week 2 | -3.1 open comedone count | Standard Deviation 8.2 |
| Vehicle Foam | Absolute Change in Open Comedone Count From Baseline at Weeks 2, 4, 8, and 12 | Week 8 | -5.8 open comedone count | Standard Deviation 9.46 |
| Vehicle Foam | Absolute Change in Open Comedone Count From Baseline at Weeks 2, 4, 8, and 12 | Week 4 | -4.2 open comedone count | Standard Deviation 9.06 |
Secondary
Absolute Change in Papule Count From Baseline at Weeks 2, 4, 8, and 12
A papule is a circumscribed, solid elevation of the skin with no visible fluid. Change from basline in papule count at Weeks 2, 4, 8, and 12 was calculated as the papule count at Week 2/4/8/12 minus the papule count at Baseline.
Time frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
Population: ITT Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tazarotene Foam | Absolute Change in Papule Count From Baseline at Weeks 2, 4, 8, and 12 | Week 2 | -4.3 papule count | Standard Deviation 7.23 |
| Tazarotene Foam | Absolute Change in Papule Count From Baseline at Weeks 2, 4, 8, and 12 | Week 4 | -8.3 papule count | Standard Deviation 8.76 |
| Tazarotene Foam | Absolute Change in Papule Count From Baseline at Weeks 2, 4, 8, and 12 | Week 8 | -12.0 papule count | Standard Deviation 9.55 |
| Tazarotene Foam | Absolute Change in Papule Count From Baseline at Weeks 2, 4, 8, and 12 | Week 12 | -13.5 papule count | Standard Deviation 10.06 |
| Vehicle Foam | Absolute Change in Papule Count From Baseline at Weeks 2, 4, 8, and 12 | Week 12 | -11.5 papule count | Standard Deviation 10 |
| Vehicle Foam | Absolute Change in Papule Count From Baseline at Weeks 2, 4, 8, and 12 | Week 2 | -4.3 papule count | Standard Deviation 8.28 |
| Vehicle Foam | Absolute Change in Papule Count From Baseline at Weeks 2, 4, 8, and 12 | Week 8 | -10.4 papule count | Standard Deviation 9.13 |
| Vehicle Foam | Absolute Change in Papule Count From Baseline at Weeks 2, 4, 8, and 12 | Week 4 | -7.8 papule count | Standard Deviation 9.27 |
Secondary
Absolute Change in Pustule Count From Baseline at Weeks 2, 4, 8, and 12
A pustule is a small elevation of the skin containing cloudy or purulent material usually consisting of necrotic inflammatory cells. Change from basline in pustule count at Weeks 2, 4, 8, and 12 was calculated as the pustule count at Week 2/4/8/12 minus the pustule count at Baseline.
Time frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
Population: ITT Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tazarotene Foam | Absolute Change in Pustule Count From Baseline at Weeks 2, 4, 8, and 12 | Week 4 | -2.4 pustule count | Standard Deviation 6.21 |
| Tazarotene Foam | Absolute Change in Pustule Count From Baseline at Weeks 2, 4, 8, and 12 | Week 2 | -1.5 pustule count | Standard Deviation 5.7 |
| Tazarotene Foam | Absolute Change in Pustule Count From Baseline at Weeks 2, 4, 8, and 12 | Week 8 | -3.7 pustule count | Standard Deviation 6.08 |
| Tazarotene Foam | Absolute Change in Pustule Count From Baseline at Weeks 2, 4, 8, and 12 | Week 12 | -4.2 pustule count | Standard Deviation 6.42 |
| Vehicle Foam | Absolute Change in Pustule Count From Baseline at Weeks 2, 4, 8, and 12 | Week 12 | -3.2 pustule count | Standard Deviation 5.68 |
| Vehicle Foam | Absolute Change in Pustule Count From Baseline at Weeks 2, 4, 8, and 12 | Week 4 | -2.4 pustule count | Standard Deviation 5.04 |
| Vehicle Foam | Absolute Change in Pustule Count From Baseline at Weeks 2, 4, 8, and 12 | Week 8 | -2.9 pustule count | Standard Deviation 5.14 |
| Vehicle Foam | Absolute Change in Pustule Count From Baseline at Weeks 2, 4, 8, and 12 | Week 2 | -1.3 pustule count | Standard Deviation 4.46 |
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); Week 2, 4, 8, and 12
Population: ITT Analysis Set: only those participants 16 years of age or younger and whose CDLQI scores were calculated at Baseline and at Weeks 2, 4, 8, or 12 were evaluated for change in DLQI score at respective week.
| 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=153, 163 | 1.3 scores on a scale | Standard Deviation 4.01 |
| 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=143, 158 | -0.9 scores on a scale | Standard Deviation 3.3 |
| 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=137, 158 | -1.6 scores on a scale | Standard Deviation 3.19 |
| 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=137, 153 | -1.6 scores on a scale | Standard Deviation 4.06 |
| 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=137, 153 | -2.0 scores on a scale | Standard Deviation 3.58 |
| 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=153, 163 | -1.5 scores on a scale | Standard Deviation 2.96 |
| 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=137, 158 | -1.9 scores on a scale | Standard Deviation 3.13 |
| 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=143, 158 | -1.9 scores on a scale | Standard Deviation 3.33 |
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 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=175, 178 | -1.3 scores on a scale | Standard Deviation 5.28 |
| 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=170, 184 | -2.4 scores on a scale | Standard Deviation 4.8 |
| 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=163, 176 | -2.9 scores on a scale | Standard Deviation 5.14 |
| 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=162, 176 | -3.7 scores on a scale | Standard Deviation 5.33 |
| 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=162, 176 | -3.2 scores on a scale | Standard Deviation 4.98 |
| 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=175, 178 | -1.9 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=163, 176 | -3.1 scores on a scale | Standard Deviation 4.64 |
| 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=170, 184 | -2.7 scores on a scale | Standard Deviation 3.92 |
Secondary
Number of Participants With a 2-G Improvement in ISGA Score and an ISGA Score of 0 or 1 at Weeks 2, 4, 8, and 12
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, 8, and 12
Population: ITT Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tazarotene Foam | Number of Participants With a 2-G Improvement in ISGA Score and an ISGA Score of 0 or 1 at Weeks 2, 4, 8, and 12 | Week 4 | 26 participants |
| Tazarotene Foam | Number of Participants With a 2-G Improvement in ISGA Score and an ISGA Score of 0 or 1 at Weeks 2, 4, 8, and 12 | Week 8 | 56 participants |
| Tazarotene Foam | Number of Participants With a 2-G Improvement in ISGA Score and an ISGA Score of 0 or 1 at Weeks 2, 4, 8, and 12 | Week 12 | 103 participants |
| Tazarotene Foam | Number of Participants With a 2-G Improvement in ISGA Score and an ISGA Score of 0 or 1 at Weeks 2, 4, 8, and 12 | Week 2 | 5 participants |
| Vehicle Foam | Number of Participants With a 2-G Improvement in ISGA Score and an ISGA Score of 0 or 1 at Weeks 2, 4, 8, and 12 | Week 12 | 49 participants |
| Vehicle Foam | Number of Participants With a 2-G Improvement in ISGA Score and an ISGA Score of 0 or 1 at Weeks 2, 4, 8, and 12 | Week 2 | 2 participants |
| Vehicle Foam | Number of Participants With a 2-G Improvement in ISGA Score and an ISGA Score of 0 or 1 at Weeks 2, 4, 8, and 12 | Week 4 | 12 participants |
| Vehicle Foam | Number of Participants With a 2-G Improvement in ISGA Score and an ISGA Score of 0 or 1 at Weeks 2, 4, 8, and 12 | Week 8 | 26 participants |
Secondary
Number of Participants With a Minimum 2 G 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 G Improvement in ISGA Score at Weeks 2, 4, and 8 | Week 2 | 8 participants |
| Tazarotene Foam | Number of Participants With a Minimum 2 G Improvement in ISGA Score at Weeks 2, 4, and 8 | Week 4 | 33 participants |
| Tazarotene Foam | Number of Participants With a Minimum 2 G Improvement in ISGA Score at Weeks 2, 4, and 8 | Week 8 | 69 participants |
| Vehicle Foam | Number of Participants With a Minimum 2 G Improvement in ISGA Score at Weeks 2, 4, and 8 | Week 2 | 4 participants |
| Vehicle Foam | Number of Participants With a Minimum 2 G Improvement in ISGA Score at Weeks 2, 4, and 8 | Week 4 | 16 participants |
| Vehicle Foam | Number of Participants With a Minimum 2 G Improvement in ISGA Score at Weeks 2, 4, and 8 | Week 8 | 35 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 8 | 56 participants |
| Tazarotene Foam | Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8 | Week 2 | 5 participants |
| Tazarotene Foam | Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8 | Week 4 | 26 participants |
| Vehicle Foam | Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8 | Week 2 | 2 participants |
| Vehicle Foam | Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8 | Week 4 | 12 participants |
| Vehicle Foam | Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8 | Week 8 | 26 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 | 83 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 | 136 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 | 171 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 | 213 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 | 153 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 | 93 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 | 125 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 | 114 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 | Baseline, Missing G | 0 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Week 12, G0 | 168 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | MDT, G0 | 57 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Baseline, G1 | 60 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | MDT, G1 | 169 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Week 12, G2 | 34 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | MDT, G2 | 105 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Baseline, G2 | 12 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | MDT, G3 | 104 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Week 12, G1 | 97 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | MDT, Missing G | 12 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Week 12, G3 | 8 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Baseline, G3 | 2 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Week 12, Missing G | 66 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Baseline, G0 | 299 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Week 12, Missing G | 38 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Week 12, G0 | 223 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Week 12, G1 | 86 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Week 12, G2 | 15 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Baseline, G0 | 290 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Baseline, G1 | 62 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Baseline, G2 | 16 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Baseline, G3 | 1 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 | MDT, G0 | 109 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | MDT, G1 | 181 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 | MDT, G3 | 16 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | Week 12, G3 | 7 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants | MDT, Missing G | 8 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 dryness 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, G2 | 13 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | MDT, G3 | 61 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Baseline, G0 | 316 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | MDT, G4 | 5 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Baseline, G3 | 5 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | MDT, Missing G | 11 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | MDT, G2 | 87 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Week 12, G0 | 219 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Baseline, Missing G | 0 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Week 12, G1 | 73 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Baseline, G1 | 39 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Week 12, G2 | 14 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Week 12, G3 | 1 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | MDT, G0 | 73 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 | Baseline, 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 | 66 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | MDT, G1 | 136 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Week 12, Missing G | 38 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | MDT, G1 | 124 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Week 12, G2 | 2 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Baseline, G0 | 312 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Baseline, G1 | 43 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Baseline, G2 | 8 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 | Baseline, Missing G | 0 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | MDT, G0 | 193 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | MDT, G2 | 36 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | MDT, G3 | 7 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | MDT, G4 | 1 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | MDT, Missing G | 8 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Week 12, G0 | 294 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Week 12, G1 | 35 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 | Week 12, G4 | 0 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator | Baseline, G3 | 6 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 | Baseline, G1 | 65 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Maximum During Treatment (MDT), G0 | 76 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Week 12, Missing G | 66 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | MDT, G1 | 117 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Baseline, G2 | 21 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | MDT, G2 | 111 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Week 12, G1 | 93 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | MDT, G3 | 56 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | MDT, G4 | 2 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Baseline, G3 | 40 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | MDT, Missing G | 11 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Baseline, G0 | 247 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Week 12, G0 | 175 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 | Week 12, G3 | 9 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Week 12, G2 | 30 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Week 12, G4 | 0 participants |
| Tazarotene 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, G4 | 0 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Week 12, G0 | 218 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Week 12, G1 | 73 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Week 12, Missing G | 38 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Baseline, G0 | 234 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Baseline, G1 | 75 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Baseline, G2 | 20 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Baseline, G3 | 40 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 | Baseline, Missing G | 0 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Maximum During Treatment (MDT), G0 | 141 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | MDT, G1 | 132 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | MDT, G2 | 51 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 | MDT, Missing G | 8 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Week 12, G2 | 21 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | Week 12, G3 | 19 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator | MDT, G3 | 37 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 | MDT, G0 | 57 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Baseline, G0 | 205 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | MDT, G2 | 96 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Baseline, G3 | 4 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | MDT, G3 | 39 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Baseline, G1 | 133 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | MDT, Missing G | 12 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Week 12, G3 | 4 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Week 12, G0 | 176 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Baseline, G2 | 31 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Week 12, G1 | 105 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | MDT, G1 | 169 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Week 12, G2 | 22 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Baseline, Missing G | 0 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Week 12, Missing G | 66 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Week 12, Missing G | 38 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | MDT, G1 | 155 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Week 12, G3 | 6 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Baseline, G0 | 209 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Baseline, G1 | 131 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Baseline, G3 | 2 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 | 145 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | MDT, G2 | 51 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | MDT, G3 | 10 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | MDT, Missing G | 8 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Week 12, G0 | 224 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Week 12, G1 | 88 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Week 12, G2 | 13 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants | Baseline, G2 | 27 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, G3 | 2 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 | MDT, G3 | 28 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 | MDT, G4 | 5 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Baseline, G0 | 342 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | MDT, Missing G | 11 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Baseline, Missing G | 0 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Week 12, G1 | 48 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Baseline, G2 | 7 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Week 12, G2 | 7 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | MDT, G0 | 108 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Week 12, G3 | 1 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Week 12, G0 | 251 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 | MDT, G1 | 152 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Week 12, Missing G | 66 participants |
| Tazarotene Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | MDT, G2 | 69 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Week 12, Missing G | 38 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | MDT, Missing G | 8 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 | Baseline, G1 | 18 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Baseline, G2 | 6 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Baseline, G3 | 6 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 | Baseline, Missing G | 0 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | MDT, G0 | 255 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | MDT, G1 | 85 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | MDT, G2 | 18 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | MDT, G3 | 3 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 | Week 12, G0 | 313 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Week 12, G1 | 17 participants |
| Vehicle Foam | Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator | Week 12, G2 | 1 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 | Week 12, G4 | 0 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 percentage change | Standard Deviation 26.12 |
| Tazarotene Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | ILs, Week 4 | -32.9 percentage change | Standard Deviation 30.18 |
| Tazarotene Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | ILs, Week 8 | -48.1 percentage change | Standard Deviation 30.99 |
| Tazarotene Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | ILs, Week 12 | -54.5 percentage change | Standard Deviation 32.79 |
| Tazarotene Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | NILs, Week 2 | -23.7 percentage change | Standard Deviation 25.82 |
| Tazarotene Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | NILs, Week 4 | -39.2 percentage change | Standard Deviation 27.3 |
| Tazarotene Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | NILs, Week 8 | -50.6 percentage change | Standard Deviation 27.35 |
| Tazarotene Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | NILs, Week 12 | -56.7 percentage change | Standard Deviation 28.84 |
| Tazarotene Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | TLs, Week 2 | -21.6 percentage change | Standard Deviation 20.44 |
| Tazarotene Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | TLs, Week 4 | -36.8 percentage change | Standard Deviation 23.43 |
| Tazarotene Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | TLs, Week 8 | -49.7 percentage change | Standard Deviation 24.65 |
| Tazarotene Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | TLs, Week 12 | -56.0 percentage change | Standard Deviation 26.76 |
| Vehicle Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | TLs, Week 8 | -38.4 percentage change | Standard Deviation 24.33 |
| Vehicle Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | ILs, Week 2 | -17.4 percentage change | Standard Deviation 26.16 |
| Vehicle Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | NILs, Week 8 | -36.6 percentage change | Standard Deviation 27.81 |
| Vehicle Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | ILs, Week 4 | -31.4 percentage change | Standard Deviation 29.13 |
| Vehicle Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | TLs, Week 4 | -28.9 percentage change | Standard Deviation 23.35 |
| Vehicle Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | ILs, Week 8 | -41.0 percentage change | Standard Deviation 28.77 |
| Vehicle Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | NILs, Week 12 | -41.2 percentage change | Standard Deviation 31.09 |
| Vehicle Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | ILs, Week 12 | -45.3 percentage change | Standard Deviation 30.72 |
| Vehicle Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | TLs, Week 12 | -42.6 percentage change | Standard Deviation 26.8 |
| Vehicle Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | NILs, Week 2 | -17.3 percentage change | Standard Deviation 25.03 |
| Vehicle Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | TLs, Week 2 | -17.1 percentage change | Standard Deviation 20.38 |
| Vehicle Foam | Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 | NILs, Week 4 | -27.3 percentage change | Standard Deviation 29.28 |
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 |