Acne Vulgaris
Conditions
Keywords
Acne Vulgaris, Acne
Brief summary
This is a Randomized, Double-Blind, Controlled Study to evaluate the Safety and Efficacy of a clindamycin / benzoyl peroxide gel in Subjects with Acne Vulgaris
Detailed description
A multicenter, randomized, double-blind, comparator and vehicle-controlled study in subjects with acne vulgaris. Approximately 1320 subjects will be enrolled. Subjects will be randomized to 1 of 4 parallel study groups in a 1:1:1:1 ratio (clindamycin / benzoyl peroxide gel:clindamycin gel:BPO gel:vehicle gel).
Interventions
DRUGclindamycin / benzoyl peroxide gel
Once a day application to the face
DRUGclindamycin gel
Once a day application to the face
DRUGBPO gel
Once a day application to the face
DRUGvehicle gel
Once a day application to the face
Sponsors
Rho, Inc.
Quintiles, Inc.
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
* Be 12 to 45 years of age, inclusive, and in good general health. * Clinical diagnosis of acne vulgaris * Females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product. * Have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study. * Have the ability to understand and sign a written informed consent form, which must be completed prior to study specific tasks being performed. Subjects under the legal age of consent in the state/province/country where the study is conducted must provide assent and have the written informed consent of a parent or guardian.
Exclusion criteria
* Are pregnant or breast-feeding. * Have a history or presence of other conditions that may increase the risk of the subject participating in the study and/or affect the evaluated outcomes. * Used topical antibiotics on the face or used systemic antibiotics within the past 2 weeks. * Used topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular, or intra-lesional steroids other than for facial acne is acceptable. * Used systemic retinoids within the past 6 months or topical retinoids within the past 6 weeks. * Received treatment with estrogens (including oral, implanted, injected and topical contraceptives), androgens, or anti-androgenic agents for 12 weeks or less immediately prior to starting study product. Subjects who have been treated with estrogens, as described above, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to start of study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study. * Used topical anti-acne medications (eg, BPO, azelaic acid, resorcinol, salicylates, etc.) within the past 2 weeks. * Used abradents or facial procedures, within the past 2 weeks. * Use medications that may exacerbate acne. * Have a known hypersensitivity or have had previous allergic reaction to any of the active components, lincomycin, or excipients of the study product. * Used any investigational therapy within the past 4 weeks, or currently participating in another clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 | Baseline (Day 1) and Week 12 | During each study visit, investigators/assessors evaluated acne severity of the participants' faces using the ISGA scale: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L. |
| Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts | Baseline (Day 1) and Week 12 | During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules \[small inflamed elevation of the skin that is filled with pus\], papules \[solid elevation of skin with no visible fluid\], nodules \[larger than papules with significant depth\]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin). Missing values were imputed using the last observation carried forward (LOCF) method. |
| Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts | Baseline (Day 1) and Week 12 | During each study visit, trained study personnel at every investigational center assessed the non-inflammatory (open comedones \[blackheads\] and closed comedones \[whiteheads\]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin). |
| Mean Change From Baseline to Week 12 in Total Lesion Counts | Baseline (Day 1) and Week 12 | During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline to Week 12 in Temperature | Baseline (Day 1) and Week 12 | Temperature was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline. |
| Mean Change From Baseline to Week 12 in Pulse Rate | Baseline (Day 1) and Week 12 | Pulse rate was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline. |
| Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Baseline; Weeks 2, 4, 8, and 12 | Erythema (Er, redness), dryness (Dr), and peeling (Pn), were evaluated independently by the investigator as: 0 (absent)=no Er, Dr, or Pn; 1 (slight)=faint red/pink coloration (col.), barely perceptible Dr with no flakes or fissure, mild localized Pn; 2 (mild)=light red/pink col., perceptible Dr with no flakes/fissure, mild and diffuse Pn; 3 (moderate)=medium red col., easily noted Dr and flakes but no fissure; 4 (severe)=beet red col., Dr with flakes and fissure, prominent dense Pn. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the the value at Baseline. |
| Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory) | Baseline (Day 1) and Week 12 | During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 12 was calculated as the value at Week 12 minus the value at Baseline divided by the Baseline value \* 100. |
| Mean Duration of Study Product Use | Baseline (Day 1) through Week 12 | Mean duration of study product use was calculated as the average total duration inclusive of missed applications of the study product. |
| Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation | Baseline (Day 1) through Week 12 | An AE included, but was not limited to, any clinically significant worsening of a pre-existing condition; an event occurring from overdose (i.e., a dose higher than that indicated in the protocol) of the study product, whether accidental or intentional; an event occurring from abuse (e.g., use for nonstudy reasons) of the study product; or an event that was associated with the discontinuation of the use of the study product. |
| Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Baseline; Weeks 2, 4, 8, and 12 | Itching and burning/stinging (piercing pain) were evaluated independently by the investigator as: 0 (none)=normal, no discomfort; 1 (slight)=noticeable discomfort that caused intermittent awareness; 2 (moderate)=noticeable discomfort that caused intermittent awareness and interfered occasionally with normal daily activities; 3 (strong)=definite continuous discomfort that interfered with normal daily activities. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the value at Baseline. |
| Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12 | Week 12 | During each study visit, participants evaluated their facial acne (excluding the scalp) using the SGA scale: 0=free of acne, with only an occasional blackhead/whitehead; 1=several blackheads/whiteheads and small pimples, no tender deep-seated bumps/cysts; 2=several to many blackheads/whiteheads and small to medium-sized pimples, one deep-seated bump/cyst; 3=many blackheads/whiteheads, many medium- to large-sized pimples, few deep-seated bumps/cysts; 4=presence of blackheads/whiteheads, several to many medium- to large-sized pimples, deep-seated bumps/cysts dominate. |
| Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12 | Week 12 | During each study visit, investigators/assessors evaluated the acne severity of participants' faces using the ISGA scal: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L. |
| Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure | Baseline (Day 1) and Week 12 | Systolic and diastolic blood pressure were measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline. |
Countries
Belize, Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Duac Low-dose (LD) Gel Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks | 327 |
| Clindamycin Gel Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks | 328 |
| BPO Gel Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks | 328 |
| Vehicle Gel Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks | 332 |
| Total | 1,315 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 2 | 2 |
| Overall Study | Lost to Follow-up | 8 | 12 | 11 | 8 |
| Overall Study | Other: Lack of Efficacy/Lost Medication | 1 | 5 | 4 | 2 |
| Overall Study | Protocol Violation | 1 | 2 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 16 | 14 | 15 | 26 |
Baseline characteristics
| Characteristic | Duac Low-dose (LD) Gel | Clindamycin Gel | BPO Gel | Vehicle Gel | Total |
|---|---|---|---|---|---|
| Age, Continuous | 20.0 Years STANDARD_DEVIATION 7 | 20.2 Years STANDARD_DEVIATION 6.9 | 20.6 Years STANDARD_DEVIATION 7.1 | 20.7 Years STANDARD_DEVIATION 7.4 | 20.4 Years STANDARD_DEVIATION 7.1 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 3 participants | 1 participants | 0 participants | 0 participants | 4 participants |
| Race/Ethnicity, Customized Asian | 13 participants | 9 participants | 17 participants | 16 participants | 55 participants |
| Race/Ethnicity, Customized Black | 47 participants | 37 participants | 54 participants | 54 participants | 192 participants |
| Race/Ethnicity, Customized Multiracial | 5 participants | 7 participants | 7 participants | 4 participants | 23 participants |
| Race/Ethnicity, Customized White | 259 participants | 274 participants | 251 participants | 258 participants | 1042 participants |
| Sex: Female, Male Female | 202 Participants | 180 Participants | 203 Participants | 210 Participants | 795 Participants |
| Sex: Female, Male Male | 125 Participants | 148 Participants | 125 Participants | 122 Participants | 520 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 72 / 327 | 83 / 328 | 102 / 328 | 87 / 332 |
| serious Total, serious adverse events | 0 / 327 | 0 / 328 | 1 / 328 | 0 / 332 |
Outcome results
Primary
Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts
During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules \[small inflamed elevation of the skin that is filled with pus\], papules \[solid elevation of skin with no visible fluid\], nodules \[larger than papules with significant depth\]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin). Missing values were imputed using the last observation carried forward (LOCF) method.
Time frame: Baseline (Day 1) and Week 12
Population: ITT Population. Participants who missed \>=16 days of treatment or reported lost medication and never began treatment were excluded from the analysis. In the LOCF method, the last available observation, including BL, was used to estimate subsequent missing data points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duac Low-dose (LD) Gel | Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts | -18.2 lesion counts | Standard Deviation 10.4 |
| Clindamycin Gel | Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts | -15.6 lesion counts | Standard Deviation 11.6 |
| BPO Gel | Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts | -16.8 lesion counts | Standard Deviation 11.5 |
| Vehicle Gel | Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts | -13.1 lesion counts | Standard Deviation 12.1 |
p-value: <0.001ANCOVA
p-value: 0.015ANCOVA
p-value: <0.001ANCOVA
Primary
Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts
During each study visit, trained study personnel at every investigational center assessed the non-inflammatory (open comedones \[blackheads\] and closed comedones \[whiteheads\]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin).
Time frame: Baseline (Day 1) and Week 12
Population: ITT Population. Participants who missed \>=16 days of treatment or who reported they had lost their medication and never began treatment were excluded from the analysis. Missing values for all other participants were imputed using the LOCF method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duac Low-dose (LD) Gel | Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts | -24.8 lesion counts | Standard Deviation 20.1 |
| Clindamycin Gel | Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts | -19.8 lesion counts | Standard Deviation 19.8 |
| BPO Gel | Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts | -22.2 lesion counts | Standard Deviation 17.6 |
| Vehicle Gel | Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts | -14.8 lesion counts | Standard Deviation 21.6 |
p-value: <0.001ANCOVA
p-value: 0.102ANCOVA
p-value: <0.001ANCOVA
Primary
Mean Change From Baseline to Week 12 in Total Lesion Counts
During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts.
Time frame: Baseline (Day 1) and Week 12
Population: ITT Population. Participants who missed \>=16 days of treatment or who reported they had lost their medication and never began treatment were excluded from the analysis. Missing values for all other participants were imputed using the LOCF method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duac Low-dose (LD) Gel | Mean Change From Baseline to Week 12 in Total Lesion Counts | -43.0 lesion counts | Standard Deviation 27.1 |
| Clindamycin Gel | Mean Change From Baseline to Week 12 in Total Lesion Counts | -35.5 lesion counts | Standard Deviation 27.1 |
| BPO Gel | Mean Change From Baseline to Week 12 in Total Lesion Counts | -39.0 lesion counts | Standard Deviation 25 |
| Vehicle Gel | Mean Change From Baseline to Week 12 in Total Lesion Counts | -27.8 lesion counts | Standard Deviation 29.8 |
p-value: <0.001ANCOVA
p-value: 0.032ANCOVA
p-value: <0.001ANCOVA
Primary
Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
During each study visit, investigators/assessors evaluated acne severity of the participants' faces using the ISGA scale: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.
Time frame: Baseline (Day 1) and Week 12
Population: Intent-to-Treat (ITT) Population: all participants who were randomized to and received at least 1 application of study product. Participants with missing Week 12 evaluations were considered failures. Failures are defined as those participants with a 1-grade improvement, no improvement, or a worsening.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Duac Low-dose (LD) Gel | Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 | 129 participants |
| Clindamycin Gel | Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 | 82 participants |
| BPO Gel | Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 | 100 participants |
| Vehicle Gel | Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 | 59 participants |
p-value: <0.001Cochran-Mantel-Haenszel
p-value: 0.016Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Mean Change From Baseline to Week 12 in Pulse Rate
Pulse rate was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.
Time frame: Baseline (Day 1) and Week 12
Population: ITT Population. Only those participants with data available at both Baseline and Week 12 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duac Low-dose (LD) Gel | Mean Change From Baseline to Week 12 in Pulse Rate | 1 Beats per minute (bpm) | Standard Deviation 10 |
| Clindamycin Gel | Mean Change From Baseline to Week 12 in Pulse Rate | 2 Beats per minute (bpm) | Standard Deviation 11 |
| BPO Gel | Mean Change From Baseline to Week 12 in Pulse Rate | 2 Beats per minute (bpm) | Standard Deviation 9 |
| Vehicle Gel | Mean Change From Baseline to Week 12 in Pulse Rate | 2 Beats per minute (bpm) | Standard Deviation 11 |
Secondary
Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure
Systolic and diastolic blood pressure were measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.
Time frame: Baseline (Day 1) and Week 12
Population: ITT Population. Only those participants with data available at both Baseline and Week 12 were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Low-dose (LD) Gel | Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure | Systolic blood pressure | 0 Millimeters of mercury (mmHg) | Standard Deviation 10 |
| Duac Low-dose (LD) Gel | Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure | Diastolic blood pressure | 0 Millimeters of mercury (mmHg) | Standard Deviation 8 |
| Clindamycin Gel | Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure | Diastolic blood pressure | 1 Millimeters of mercury (mmHg) | Standard Deviation 9 |
| Clindamycin Gel | Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure | Systolic blood pressure | 0 Millimeters of mercury (mmHg) | Standard Deviation 11 |
| BPO Gel | Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure | Systolic blood pressure | 0 Millimeters of mercury (mmHg) | Standard Deviation 12 |
| BPO Gel | Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure | Diastolic blood pressure | 0 Millimeters of mercury (mmHg) | Standard Deviation 8 |
| Vehicle Gel | Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure | Systolic blood pressure | 0 Millimeters of mercury (mmHg) | Standard Deviation 10 |
| Vehicle Gel | Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure | Diastolic blood pressure | 0 Millimeters of mercury (mmHg) | Standard Deviation 8 |
Secondary
Mean Change From Baseline to Week 12 in Temperature
Temperature was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.
Time frame: Baseline (Day 1) and Week 12
Population: ITT Population. Only those participants with data available at both Baseline and Week 12 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duac Low-dose (LD) Gel | Mean Change From Baseline to Week 12 in Temperature | -0.1 Degrees centigrade | Standard Deviation 0.4 |
| Clindamycin Gel | Mean Change From Baseline to Week 12 in Temperature | 0.0 Degrees centigrade | Standard Deviation 0.4 |
| BPO Gel | Mean Change From Baseline to Week 12 in Temperature | 0.0 Degrees centigrade | Standard Deviation 0.4 |
| Vehicle Gel | Mean Change From Baseline to Week 12 in Temperature | 0.0 Degrees centigrade | Standard Deviation 0.4 |
Secondary
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling
Erythema (Er, redness), dryness (Dr), and peeling (Pn), were evaluated independently by the investigator as: 0 (absent)=no Er, Dr, or Pn; 1 (slight)=faint red/pink coloration (col.), barely perceptible Dr with no flakes or fissure, mild localized Pn; 2 (mild)=light red/pink col., perceptible Dr with no flakes/fissure, mild and diffuse Pn; 3 (moderate)=medium red col., easily noted Dr and flakes but no fissure; 4 (severe)=beet red col., Dr with flakes and fissure, prominent dense Pn. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the the value at Baseline.
Time frame: Baseline; Weeks 2, 4, 8, and 12
Population: ITT Population. Only those participants with data available at both Baseline and the indicated assessment week were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Low-dose (LD) Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Erythema, Week 12, n=297, 296, 296, 294 | -0.17 scores on a scale | Standard Deviation 0.66 |
| Duac Low-dose (LD) Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Peeling, Week 2, n=298, 302, 306, 306 | 0.03 scores on a scale | Standard Deviation 0.43 |
| Duac Low-dose (LD) Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Dryness, Week 2, n=298, 302, 306, 306 | 0.07 scores on a scale | Standard Deviation 0.54 |
| Duac Low-dose (LD) Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Dryness, Week 8, n=297, 296, 294, 293 | 0.00 scores on a scale | Standard Deviation 0.53 |
| Duac Low-dose (LD) Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Erythema, Week 4, n=298, 300, 299, 306 | -0.07 scores on a scale | Standard Deviation 0.66 |
| Duac Low-dose (LD) Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Dryness, Week 4, n=298, 300, 299, 306 | 0.05 scores on a scale | Standard Deviation 0.58 |
| Duac Low-dose (LD) Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Peeling, Week 8, n=297, 296, 294, 293 | -0.01 scores on a scale | Standard Deviation 0.41 |
| Duac Low-dose (LD) Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Dryness, Week 12, n=297, 296, 296, 294 | -0.07 scores on a scale | Standard Deviation 0.62 |
| Duac Low-dose (LD) Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Peeling, Week 4, n=298, 300, 299, 306 | -0.01 scores on a scale | Standard Deviation 0.39 |
| Duac Low-dose (LD) Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Peeling, Week 12, n=297, 296, 296, 294 | -0.08 scores on a scale | Standard Deviation 0.44 |
| Duac Low-dose (LD) Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Erythema, Week 2, n=298, 302, 306, 306 | -0.05 scores on a scale | Standard Deviation 0.63 |
| Duac Low-dose (LD) Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Erythema, Week 8, n=297, 296, 294, 293 | -0.12 scores on a scale | Standard Deviation 0.71 |
| Clindamycin Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Erythema, Week 12, n=297, 296, 296, 294 | -0.18 scores on a scale | Standard Deviation 0.63 |
| Clindamycin Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Peeling, Week 4, n=298, 300, 299, 306 | 0.00 scores on a scale | Standard Deviation 0.36 |
| Clindamycin Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Erythema, Week 2, n=298, 302, 306, 306 | -0.01 scores on a scale | Standard Deviation 0.58 |
| Clindamycin Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Dryness, Week 2, n=298, 302, 306, 306 | 0.03 scores on a scale | Standard Deviation 0.48 |
| Clindamycin Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Dryness, Week 12, n=297, 296, 296, 294 | -0.10 scores on a scale | Standard Deviation 0.53 |
| Clindamycin Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Peeling, Week 2, n=298, 302, 306, 306 | 0.02 scores on a scale | Standard Deviation 0.36 |
| Clindamycin Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Dryness, Week 8, n=297, 296, 294, 293 | -0.02 scores on a scale | Standard Deviation 0.58 |
| Clindamycin Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Erythema, Week 8, n=297, 296, 294, 293 | -0.08 scores on a scale | Standard Deviation 0.67 |
| Clindamycin Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Erythema, Week 4, n=298, 300, 299, 306 | -0.07 scores on a scale | Standard Deviation 0.64 |
| Clindamycin Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Peeling, Week 8, n=297, 296, 294, 293 | -0.01 scores on a scale | Standard Deviation 0.42 |
| Clindamycin Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Peeling, Week 12, n=297, 296, 296, 294 | -0.06 scores on a scale | Standard Deviation 0.4 |
| Clindamycin Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Dryness, Week 4, n=298, 300, 299, 306 | -0.02 scores on a scale | Standard Deviation 0.51 |
| BPO Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Dryness, Week 4, n=298, 300, 299, 306 | 0.08 scores on a scale | Standard Deviation 0.55 |
| BPO Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Erythema, Week 12, n=297, 296, 296, 294 | -0.17 scores on a scale | Standard Deviation 0.67 |
| BPO Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Dryness, Week 2, n=298, 302, 306, 306 | 0.09 scores on a scale | Standard Deviation 0.61 |
| BPO Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Peeling, Week 8, n=297, 296, 294, 293 | -0.01 scores on a scale | Standard Deviation 0.4 |
| BPO Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Erythema, Week 2, n=298, 302, 306, 306 | -0.07 scores on a scale | Standard Deviation 0.56 |
| BPO Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Erythema, Week 4, n=298, 300, 299, 306 | -0.08 scores on a scale | Standard Deviation 0.67 |
| BPO Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Erythema, Week 8, n=297, 296, 294, 293 | -0.15 scores on a scale | Standard Deviation 0.68 |
| BPO Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Dryness, Week 8, n=297, 296, 294, 293 | 0.05 scores on a scale | Standard Deviation 0.57 |
| BPO Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Dryness, Week 12, n=297, 296, 296, 294 | -0.01 scores on a scale | Standard Deviation 0.57 |
| BPO Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Peeling, Week 2, n=298, 302, 306, 306 | 0.08 scores on a scale | Standard Deviation 0.51 |
| BPO Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Peeling, Week 4, n=298, 300, 299, 306 | 0.01 scores on a scale | Standard Deviation 0.39 |
| BPO Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Peeling, Week 12, n=297, 296, 296, 294 | -0.02 scores on a scale | Standard Deviation 0.5 |
| Vehicle Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Erythema, Week 4, n=298, 300, 299, 306 | -0.06 scores on a scale | Standard Deviation 0.64 |
| Vehicle Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Peeling, Week 2, n=298, 302, 306, 306 | 0.02 scores on a scale | Standard Deviation 0.41 |
| Vehicle Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Dryness, Week 12, n=297, 296, 296, 294 | -0.04 scores on a scale | Standard Deviation 0.55 |
| Vehicle Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Dryness, Week 8, n=297, 296, 294, 293 | 0.02 scores on a scale | Standard Deviation 0.56 |
| Vehicle Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Peeling, Week 12, n=297, 296, 296, 294 | -0.04 scores on a scale | Standard Deviation 0.43 |
| Vehicle Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Peeling, Week 4, n=298, 300, 299, 306 | 0.00 scores on a scale | Standard Deviation 0.4 |
| Vehicle Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Erythema, Week 2, n=298, 302, 306, 306 | -0.02 scores on a scale | Standard Deviation 0.61 |
| Vehicle Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Dryness, Week 2, n=298, 302, 306, 306 | 0.04 scores on a scale | Standard Deviation 0.5 |
| Vehicle Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Dryness, Week 4, n=298, 300, 299, 306 | 0.00 scores on a scale | Standard Deviation 0.52 |
| Vehicle Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Peeling, Week 8, n=297, 296, 294, 293 | 0.00 scores on a scale | Standard Deviation 0.43 |
| Vehicle Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Erythema, Week 12, n=297, 296, 296, 294 | -0.13 scores on a scale | Standard Deviation 0.69 |
| Vehicle Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Erythema, Week 8, n=297, 296, 294, 293 | -0.08 scores on a scale | Standard Deviation 0.73 |
Secondary
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging
Itching and burning/stinging (piercing pain) were evaluated independently by the investigator as: 0 (none)=normal, no discomfort; 1 (slight)=noticeable discomfort that caused intermittent awareness; 2 (moderate)=noticeable discomfort that caused intermittent awareness and interfered occasionally with normal daily activities; 3 (strong)=definite continuous discomfort that interfered with normal daily activities. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the value at Baseline.
Time frame: Baseline; Weeks 2, 4, 8, and 12
Population: ITT Population. Only those participants with data available at both Baseline and the indicated assessment week were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Low-dose (LD) Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Itching, Week 12, n=297, 295, 294, 293 | -0.21 scores on a scale | Standard Deviation 0.7 |
| Duac Low-dose (LD) Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Burning/Stinging, Week 8, n=297, 295, 293, 291 | -0.05 scores on a scale | Standard Deviation 0.57 |
| Duac Low-dose (LD) Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Burning/Stinging, Week 2, n=297, 301, 305, 305 | 0.02 scores on a scale | Standard Deviation 0.58 |
| Duac Low-dose (LD) Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Burning/Stinging, Week 4, n=298, 2991, 299, 305 | -0.06 scores on a scale | Standard Deviation 0.57 |
| Duac Low-dose (LD) Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Itching, Week 2, n=297, 301, 305, 305 | -0.11 scores on a scale | Standard Deviation 0.67 |
| Duac Low-dose (LD) Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Burning/Stinging, Week 12, n=297, 295, 294, 293 | -0.09 scores on a scale | Standard Deviation 0.58 |
| Duac Low-dose (LD) Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Itching, Week 8, n=297, 295, 293, 291 | -0.16 scores on a scale | Standard Deviation 0.75 |
| Duac Low-dose (LD) Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Itching, Week 4, n=298, 299, 299, 305 | -0.11 scores on a scale | Standard Deviation 0.67 |
| Clindamycin Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Burning/Stinging, Week 8, n=297, 295, 293, 291 | -0.09 scores on a scale | Standard Deviation 0.46 |
| Clindamycin Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Itching, Week 2, n=297, 301, 305, 305 | -0.18 scores on a scale | Standard Deviation 0.67 |
| Clindamycin Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Itching, Week 4, n=298, 299, 299, 305 | -0.18 scores on a scale | Standard Deviation 0.68 |
| Clindamycin Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Burning/Stinging, Week 2, n=297, 301, 305, 305 | -0.06 scores on a scale | Standard Deviation 0.48 |
| Clindamycin Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Burning/Stinging, Week 12, n=297, 295, 294, 293 | -0.13 scores on a scale | Standard Deviation 0.48 |
| Clindamycin Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Itching, Week 12, n=297, 295, 294, 293 | -0.28 scores on a scale | Standard Deviation 0.67 |
| Clindamycin Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Itching, Week 8, n=297, 295, 293, 291 | -0.24 scores on a scale | Standard Deviation 0.69 |
| Clindamycin Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Burning/Stinging, Week 4, n=298, 2991, 299, 305 | -0.09 scores on a scale | Standard Deviation 0.46 |
| BPO Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Itching, Week 12, n=297, 295, 294, 293 | -0.13 scores on a scale | Standard Deviation 0.72 |
| BPO Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Itching, Week 4, n=298, 299, 299, 305 | -0.07 scores on a scale | Standard Deviation 0.68 |
| BPO Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Itching, Week 8, n=297, 295, 293, 291 | -0.08 scores on a scale | Standard Deviation 0.68 |
| BPO Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Itching, Week 2, n=297, 301, 305, 305 | -0.04 scores on a scale | Standard Deviation 0.64 |
| BPO Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Burning/Stinging, Week 2, n=297, 301, 305, 305 | -0.02 scores on a scale | Standard Deviation 0.56 |
| BPO Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Burning/Stinging, Week 4, n=298, 2991, 299, 305 | -0.05 scores on a scale | Standard Deviation 0.55 |
| BPO Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Burning/Stinging, Week 8, n=297, 295, 293, 291 | -0.05 scores on a scale | Standard Deviation 0.55 |
| BPO Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Burning/Stinging, Week 12, n=297, 295, 294, 293 | -0.04 scores on a scale | Standard Deviation 0.6 |
| Vehicle Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Itching, Week 12, n=297, 295, 294, 293 | -0.13 scores on a scale | Standard Deviation 0.63 |
| Vehicle Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Itching, Week 4, n=298, 299, 299, 305 | -0.10 scores on a scale | Standard Deviation 0.61 |
| Vehicle Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Burning/Stinging, Week 12, n=297, 295, 294, 293 | -0.04 scores on a scale | Standard Deviation 0.49 |
| Vehicle Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Burning/Stinging, Week 8, n=297, 295, 293, 291 | -0.06 scores on a scale | Standard Deviation 0.54 |
| Vehicle Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Itching, Week 2, n=297, 301, 305, 305 | -0.06 scores on a scale | Standard Deviation 0.65 |
| Vehicle Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Burning/Stinging, Week 2, n=297, 301, 305, 305 | -0.05 scores on a scale | Standard Deviation 0.53 |
| Vehicle Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Itching, Week 8, n=297, 295, 293, 291 | -0.08 scores on a scale | Standard Deviation 0.62 |
| Vehicle Gel | Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Burning/Stinging, Week 4, n=298, 2991, 299, 305 | -0.02 scores on a scale | Standard Deviation 0.59 |
Secondary
Mean Duration of Study Product Use
Mean duration of study product use was calculated as the average total duration inclusive of missed applications of the study product.
Time frame: Baseline (Day 1) through Week 12
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duac Low-dose (LD) Gel | Mean Duration of Study Product Use | 79.5 days | Standard Deviation 16.4 |
| Clindamycin Gel | Mean Duration of Study Product Use | 78.0 days | Standard Deviation 17.9 |
| BPO Gel | Mean Duration of Study Product Use | 78.0 days | Standard Deviation 18.4 |
| Vehicle Gel | Mean Duration of Study Product Use | 77.8 days | Standard Deviation 18.4 |
Secondary
Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory)
During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 12 was calculated as the value at Week 12 minus the value at Baseline divided by the Baseline value \* 100.
Time frame: Baseline (Day 1) and Week 12
Population: ITT Population. Participants who missed \>=16 days of treatment or who reported they had lost their medication and never began treatment were excluded from the analysis. Missing values for all other participants were imputed using the LOCF method.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Low-dose (LD) Gel | Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory) | Inflammatory Lesions | -68.9 Percent change in lesion counts | Standard Deviation 29.6 |
| Duac Low-dose (LD) Gel | Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory) | Total Lesions | -59.8 Percent change in lesion counts | Standard Deviation 28 |
| Duac Low-dose (LD) Gel | Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory) | Non-inflammatory Lesions | -53.9 Percent change in lesion counts | Standard Deviation 32.2 |
| Clindamycin Gel | Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory) | Total Lesions | -49.2 Percent change in lesion counts | Standard Deviation 33.8 |
| Clindamycin Gel | Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory) | Inflammatory Lesions | -58.1 Percent change in lesion counts | Standard Deviation 35.8 |
| Clindamycin Gel | Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory) | Non-inflammatory Lesions | -43.3 Percent change in lesion counts | Standard Deviation 39.6 |
| BPO Gel | Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory) | Inflammatory Lesions | -61.8 Percent change in lesion counts | Standard Deviation 31.5 |
| BPO Gel | Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory) | Non-inflammatory Lesions | -50.8 Percent change in lesion counts | Standard Deviation 33.5 |
| BPO Gel | Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory) | Total Lesions | -55.5 Percent change in lesion counts | Standard Deviation 28.8 |
| Vehicle Gel | Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory) | Total Lesions | -40.4 Percent change in lesion counts | Standard Deviation 37.5 |
| Vehicle Gel | Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory) | Non-inflammatory Lesions | -34.0 Percent change in lesion counts | Standard Deviation 47.2 |
| Vehicle Gel | Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory) | Inflammatory Lesions | -48.8 Percent change in lesion counts | Standard Deviation 37.1 |
Secondary
Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation
An AE included, but was not limited to, any clinically significant worsening of a pre-existing condition; an event occurring from overdose (i.e., a dose higher than that indicated in the protocol) of the study product, whether accidental or intentional; an event occurring from abuse (e.g., use for nonstudy reasons) of the study product; or an event that was associated with the discontinuation of the use of the study product.
Time frame: Baseline (Day 1) through Week 12
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Duac Low-dose (LD) Gel | Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation | Application Site Dermatitis | 1 participants |
| Duac Low-dose (LD) Gel | Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation | Application Site Hypersensitivity | 0 participants |
| Duac Low-dose (LD) Gel | Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation | Application Site Pruritus | 0 participants |
| Duac Low-dose (LD) Gel | Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation | Varicella | 0 participants |
| Clindamycin Gel | Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation | Application Site Hypersensitivity | 0 participants |
| Clindamycin Gel | Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation | Application Site Pruritus | 0 participants |
| Clindamycin Gel | Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation | Varicella | 0 participants |
| Clindamycin Gel | Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation | Application Site Dermatitis | 0 participants |
| BPO Gel | Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation | Application Site Pruritus | 1 participants |
| BPO Gel | Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation | Application Site Hypersensitivity | 1 participants |
| BPO Gel | Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation | Varicella | 0 participants |
| BPO Gel | Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation | Application Site Dermatitis | 0 participants |
| Vehicle Gel | Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation | Varicella | 1 participants |
| Vehicle Gel | Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation | Application Site Hypersensitivity | 0 participants |
| Vehicle Gel | Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation | Application Site Dermatitis | 0 participants |
| Vehicle Gel | Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation | Application Site Pruritus | 1 participants |
Secondary
Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12
During each study visit, investigators/assessors evaluated the acne severity of participants' faces using the ISGA scal: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.
Time frame: Week 12
Population: ITT Population. Participants with missing Week 12 evaluations were considered failures. Failures were defined as those participants with an ISGA score \>=2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Duac Low-dose (LD) Gel | Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12 | 148 participants |
| Clindamycin Gel | Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12 | 91 participants |
| BPO Gel | Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12 | 116 participants |
| Vehicle Gel | Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12 | 81 participants |
Secondary
Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12
During each study visit, participants evaluated their facial acne (excluding the scalp) using the SGA scale: 0=free of acne, with only an occasional blackhead/whitehead; 1=several blackheads/whiteheads and small pimples, no tender deep-seated bumps/cysts; 2=several to many blackheads/whiteheads and small to medium-sized pimples, one deep-seated bump/cyst; 3=many blackheads/whiteheads, many medium- to large-sized pimples, few deep-seated bumps/cysts; 4=presence of blackheads/whiteheads, several to many medium- to large-sized pimples, deep-seated bumps/cysts dominate.
Time frame: Week 12
Population: ITT Population. Participants with missing Week 12 evaluations were considered failures. Failures were defined as those participants with an SGA score \>=2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Duac Low-dose (LD) Gel | Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12 | 209 participants |
| Clindamycin Gel | Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12 | 171 participants |
| BPO Gel | Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12 | 189 participants |
| Vehicle Gel | Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12 | 154 participants |