Acne Vulgaris
Conditions
Keywords
Acne, Acne Vulgaris, Pimples
Brief summary
Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a combination product including these actives for the treatment of acne vulgaris. You may be suitable to take part in this study because you have acne vulgaris on your face. Acne vulgaris usually affects the face, but it can also affect the skin on the chest, arms, legs, and back.
Detailed description
The study subjects must have acne vulgaris and will apply study drug to their face for 12 weeks. Study visits will occur at baseline (day 1) and at weeks 2, 4, 8, and 12. Subjects will be assessed at every visit to determine how the study drug is working. Safety will be assessed by evaluation of adverse events (AEs), vital signs, physical examinations, and withdrawals from the study.
Interventions
5% benzoyl peroxide in a gel applied topically once a day
DRUGClindamycin gel
1% clindamycin phosphate applied topically once a day
DRUGTazarotene cream
0.1 % tazarotene in a cream applied topically once a day
DRUGVehicle gel
Vehicle gel is an identical gel without the active ingredients
DRUGVehicle cream
Vehicle cream is an identical cream without the active ingredients
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
* Inclusion Criteria: Subjects must be males or females 12 to 45 years of age. * Subjects must have acne on their face. * Female subjects of childbearing potential must have a negative pregnancy test. If sexually active, one medically acceptable forms of contraception must be practiced from baseline to the last study visit. * Subjects must have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study. * Subjects must be capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements). * Subjects must be able to complete the study and to comply with study instructions.
Exclusion criteria
* Subjects who are pregnant, trying to become pregnant, or breast-feeding. * Subjects with conditions that may influence the safety and or efficacy assessments of the study including, but not limited to: regional enteritis or inflammatory bowel disease, lupus, dermatomyositis, rosacea, seborrheic dermatitis, beard folliculitis, or perioral dermatitis, subject who are immunocompromised or have had any major illness within 30 days before the screening examination * History of known or suspected intolerance including any known hypersensitivity or previous allergic reaction to any of the ingredients of the study products * Subjects who have used topical antibiotics or topical steroids on the face, facial procedures, or any investigational therapy within the past 4 weeks or systemic retinoids within the past 6 months. * Subjects who have any other disease or condition, or are using any medication, that in the judgment of the investigator would put the subject at unacceptable risk for participation in the study. * Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12 | Baseline and up to Week 12 | The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts \[only post-Baseline\]) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles). |
| Proportion of Participants With a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 | Baseline and up to Week 12 | An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory) | Baseline and up to Week 12 | The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles). |
| Proportion of Participants With an ISGA Score of 0 or 1 at Week 12 | Week 12 | An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed. |
Countries
United States
Participant flow
Recruitment details
In this multi-center, double-blind, vehicle controlled study, participants were assigned to one of the six treatment groups in a 2:2:2:2:2:1 ratio for 12 weeks.
Pre-assignment details
Participants with facial acne vulgaris, 12 to 45 years of age were enrolled in this study. A total of 596 participants were randomized and 587 participants received study product.
Participants by arm
| Arm | Count |
|---|---|
| Benzoyl Peroxide/Clindamycin + Tazarotene Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams \[g\] of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face | 106 |
| Benzoyl Peroxide/Clindamycin + Vehicle Cream Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face. | 105 |
| Benzoyl Peroxide Gel + Tazarotene Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face. | 107 |
| Clindamycin Gel + Tazarotene Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face. | 108 |
| Vehicle Gel + Tazarotene Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face. | 106 |
| Vehicle Gel + Vehicle Cream Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face. | 55 |
| Total | 587 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 2 | 2 | 3 | 1 |
| Overall Study | Lack of Efficacy | 1 | 3 | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 5 | 7 | 5 | 5 | 7 | 0 |
| Overall Study | Non-Compliance with Study Treatment | 1 | 1 | 2 | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 6 | 3 | 1 | 1 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 1 | 5 | 1 | 5 | 7 |
Baseline characteristics
| Characteristic | Benzoyl Peroxide/Clindamycin + Tazarotene | Benzoyl Peroxide/Clindamycin + Vehicle Cream | Benzoyl Peroxide Gel + Tazarotene | Clindamycin Gel + Tazarotene | Vehicle Gel + Tazarotene | Vehicle Gel + Vehicle Cream | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 19.7 Years STANDARD_DEVIATION 6.6 | 19.7 Years STANDARD_DEVIATION 6.9 | 20.2 Years STANDARD_DEVIATION 7.3 | 19.2 Years STANDARD_DEVIATION 6.2 | 21.7 Years STANDARD_DEVIATION 8.4 | 19.8 Years STANDARD_DEVIATION 6.6 | 20.1 Years STANDARD_DEVIATION 7.1 |
| Gender Female | 58 Participants | 56 Participants | 60 Participants | 60 Participants | 65 Participants | 35 Participants | 334 Participants |
| Gender Male | 48 Participants | 49 Participants | 47 Participants | 48 Participants | 41 Participants | 20 Participants | 253 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 8 Participants | 14 Participants | 5 Participants | 6 Participants | 9 Participants | 5 Participants | 47 Participants |
| Race/Ethnicity, Customized Black | 23 Participants | 16 Participants | 24 Participants | 15 Participants | 14 Participants | 8 Participants | 100 Participants |
| Race/Ethnicity, Customized Multiracial | 10 Participants | 11 Participants | 9 Participants | 8 Participants | 8 Participants | 5 Participants | 51 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 63 Participants | 63 Participants | 68 Participants | 79 Participants | 74 Participants | 37 Participants | 384 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 25 / 106 | 22 / 105 | 24 / 107 | 18 / 108 | 29 / 106 | 12 / 55 |
| serious Total, serious adverse events | 0 / 106 | 0 / 105 | 0 / 107 | 0 / 108 | 0 / 106 | 0 / 55 |
Outcome results
Primary
Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12
The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts \[only post-Baseline\]) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).
Time frame: Baseline and up to Week 12
Population: Intent-to-treat (ITT) Analysis Set: all randomized participants who received study product and reached Week 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Benzoyl Peroxide/Clindamycin + Tazarotene | Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12 | ILC, n=101, 103, 105, 105, 104, 52 | -16.8 Lesion count | Standard Deviation 14.35 |
| Benzoyl Peroxide/Clindamycin + Tazarotene | Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12 | NILC, n=101, 103, 105, 105, 104, 52 | -33.0 Lesion count | Standard Deviation 23.94 |
| Benzoyl Peroxide/Clindamycin + Tazarotene | Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12 | TLC, n=101, 103, 105, 105, 104, 52 | -49.8 Lesion count | Standard Deviation 31.78 |
| Benzoyl Peroxide/Clindamycin + Vehicle Cream | Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12 | NILC, n=101, 103, 105, 105, 104, 52 | -24.9 Lesion count | Standard Deviation 33.41 |
| Benzoyl Peroxide/Clindamycin + Vehicle Cream | Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12 | ILC, n=101, 103, 105, 105, 104, 52 | -18.1 Lesion count | Standard Deviation 14.45 |
| Benzoyl Peroxide/Clindamycin + Vehicle Cream | Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12 | TLC, n=101, 103, 105, 105, 104, 52 | -43.0 Lesion count | Standard Deviation 42.24 |
| Benzoyl Peroxide Gel + Tazarotene | Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12 | NILC, n=101, 103, 105, 105, 104, 52 | -37.1 Lesion count | Standard Deviation 29.7 |
| Benzoyl Peroxide Gel + Tazarotene | Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12 | TLC, n=101, 103, 105, 105, 104, 52 | -56.0 Lesion count | Standard Deviation 34.99 |
| Benzoyl Peroxide Gel + Tazarotene | Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12 | ILC, n=101, 103, 105, 105, 104, 52 | -18.9 Lesion count | Standard Deviation 12.84 |
| Clindamycin Gel + Tazarotene | Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12 | ILC, n=101, 103, 105, 105, 104, 52 | -18.8 Lesion count | Standard Deviation 11.49 |
| Clindamycin Gel + Tazarotene | Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12 | NILC, n=101, 103, 105, 105, 104, 52 | -37.5 Lesion count | Standard Deviation 29.51 |
| Clindamycin Gel + Tazarotene | Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12 | TLC, n=101, 103, 105, 105, 104, 52 | -56.3 Lesion count | Standard Deviation 35.42 |
| Vehicle Gel + Tazarotene | Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12 | ILC, n=101, 103, 105, 105, 104, 52 | -14.5 Lesion count | Standard Deviation 12.76 |
| Vehicle Gel + Tazarotene | Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12 | TLC, n=101, 103, 105, 105, 104, 52 | -47.6 Lesion count | Standard Deviation 33.32 |
| Vehicle Gel + Tazarotene | Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12 | NILC, n=101, 103, 105, 105, 104, 52 | -33.0 Lesion count | Standard Deviation 25.89 |
| Vehicle Gel + Vehicle Cream | Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12 | NILC, n=101, 103, 105, 105, 104, 52 | -18.9 Lesion count | Standard Deviation 28.41 |
| Vehicle Gel + Vehicle Cream | Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12 | TLC, n=101, 103, 105, 105, 104, 52 | -27.8 Lesion count | Standard Deviation 35.06 |
| Vehicle Gel + Vehicle Cream | Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12 | ILC, n=101, 103, 105, 105, 104, 52 | -8.96 Lesion count | Standard Deviation 12.63 |
p-value: 0.692ANCOVA
p-value: 0.467ANCOVA
p-value: 0.281ANCOVA
p-value: 0.075ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: 0.803ANCOVA
p-value: 0.175ANCOVA
p-value: 0.552ANCOVA
p-value: <0.001ANCOVA
p-value: 0.006ANCOVA
p-value: 0.618ANCOVA
p-value: 0.149ANCOVA
p-value: 0.255ANCOVA
p-value: <0.001ANCOVA
Primary
Proportion of Participants With a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.
Time frame: Baseline and up to Week 12
Population: ITT Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Benzoyl Peroxide/Clindamycin + Tazarotene | Proportion of Participants With a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 | 22 Percentage of participants |
| Benzoyl Peroxide/Clindamycin + Vehicle Cream | Proportion of Participants With a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 | 22 Percentage of participants |
| Benzoyl Peroxide Gel + Tazarotene | Proportion of Participants With a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 | 31 Percentage of participants |
| Clindamycin Gel + Tazarotene | Proportion of Participants With a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 | 36 Percentage of participants |
| Vehicle Gel + Tazarotene | Proportion of Participants With a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 | 20 Percentage of participants |
| Vehicle Gel + Vehicle Cream | Proportion of Participants With a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 | 5 Percentage of participants |
p-value: 0.922Cochran-Mantel-Haenszel
p-value: 0.132Cochran-Mantel-Haenszel
p-value: 0.02Cochran-Mantel-Haenszel
p-value: 0.706Cochran-Mantel-Haenszel
p-value: 0.009Cochran-Mantel-Haenszel
Secondary
Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory)
The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).
Time frame: Baseline and up to Week 12
Population: ITT Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Benzoyl Peroxide/Clindamycin + Tazarotene | Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory) | NILC, n=101, 103, 105, 105, 104, 52 | -58.0 Percent change | Standard Deviation 29.97 |
| Benzoyl Peroxide/Clindamycin + Tazarotene | Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory) | TLC, n=101, 103, 105, 105, 104, 52 | -59.1 Percent change | Standard Deviation 29.96 |
| Benzoyl Peroxide/Clindamycin + Tazarotene | Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory) | ILC, n=101, 103, 105, 105, 104, 52 | -58.3 Percent change | Standard Deviation 45.57 |
| Benzoyl Peroxide/Clindamycin + Vehicle Cream | Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory) | NILC, n=101, 103, 105, 105, 104, 52 | -39.2 Percent change | Standard Deviation 51.29 |
| Benzoyl Peroxide/Clindamycin + Vehicle Cream | Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory) | ILC, n=101, 103, 105, 105, 104, 52 | -62.4 Percent change | Standard Deviation 39.33 |
| Benzoyl Peroxide/Clindamycin + Vehicle Cream | Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory) | TLC, n=101, 103, 105, 105, 104, 52 | -47.9 Percent change | Standard Deviation 38.89 |
| Benzoyl Peroxide Gel + Tazarotene | Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory) | TLC, n=101, 103, 105, 105, 104, 52 | -62.0 Percent change | Standard Deviation 29.42 |
| Benzoyl Peroxide Gel + Tazarotene | Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory) | NILC, n=101, 103, 105, 105, 104, 52 | -60.6 Percent change | Standard Deviation 35 |
| Benzoyl Peroxide Gel + Tazarotene | Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory) | ILC, n=101, 103, 105, 105, 104, 52 | -62.4 Percent change | Standard Deviation 34.83 |
| Clindamycin Gel + Tazarotene | Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory) | NILC, n=101, 103, 105, 105, 104, 52 | -61.2 Percent change | Standard Deviation 31.6 |
| Clindamycin Gel + Tazarotene | Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory) | ILC, n=101, 103, 105, 105, 104, 52 | -65.7 Percent change | Standard Deviation 33.38 |
| Clindamycin Gel + Tazarotene | Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory) | TLC, n=101, 103, 105, 105, 104, 52 | -63.4 Percent change | Standard Deviation 28.75 |
| Vehicle Gel + Tazarotene | Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory) | NILC, n=101, 103, 105, 105, 104, 52 | -53.1 Percent change | Standard Deviation 30.56 |
| Vehicle Gel + Tazarotene | Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory) | ILC, n=101, 103, 105, 105, 104, 52 | -49.0 Percent change | Standard Deviation 40.9 |
| Vehicle Gel + Tazarotene | Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory) | TLC, n=101, 103, 105, 105, 104, 52 | -51.8 Percent change | Standard Deviation 29.18 |
| Vehicle Gel + Vehicle Cream | Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory) | ILC, n=101, 103, 105, 105, 104, 52 | -33.5 Percent change | Standard Deviation 41.1 |
| Vehicle Gel + Vehicle Cream | Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory) | TLC, n=101, 103, 105, 105, 104, 52 | -31.5 Percent change | Standard Deviation 37.59 |
| Vehicle Gel + Vehicle Cream | Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory) | NILC, n=101, 103, 105, 105, 104, 52 | -29.5 Percent change | Standard Deviation 44.05 |
p-value: 0.504ANCOVA
p-value: 0.504ANCOVA
p-value: 0.177ANCOVA
p-value: 0.084ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: 0.776ANCOVA
p-value: 0.465ANCOVA
p-value: 0.288ANCOVA
p-value: <0.001ANCOVA
p-value: 0.006ANCOVA
p-value: 0.62ANCOVA
p-value: 0.291ANCOVA
p-value: 0.085ANCOVA
p-value: <0.001ANCOVA
Secondary
Proportion of Participants With an ISGA Score of 0 or 1 at Week 12
An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.
Time frame: Week 12
Population: ITT Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Benzoyl Peroxide/Clindamycin + Tazarotene | Proportion of Participants With an ISGA Score of 0 or 1 at Week 12 | 33 Percentage of participants |
| Benzoyl Peroxide/Clindamycin + Vehicle Cream | Proportion of Participants With an ISGA Score of 0 or 1 at Week 12 | 31 Percentage of participants |
| Benzoyl Peroxide Gel + Tazarotene | Proportion of Participants With an ISGA Score of 0 or 1 at Week 12 | 27 Percentage of participants |
| Clindamycin Gel + Tazarotene | Proportion of Participants With an ISGA Score of 0 or 1 at Week 12 | 39 Percentage of participants |
| Vehicle Gel + Tazarotene | Proportion of Participants With an ISGA Score of 0 or 1 at Week 12 | 22 Percentage of participants |
| Vehicle Gel + Vehicle Cream | Proportion of Participants With an ISGA Score of 0 or 1 at Week 12 | 13 Percentage of participants |
p-value: 0.652Cochran-Mantel-Haenszel
p-value: 0.279Cochran-Mantel-Haenszel
p-value: 0.312Cochran-Mantel-Haenszel
p-value: 0.063Cochran-Mantel-Haenszel
p-value: 0.005Cochran-Mantel-Haenszel