| Primary | Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12 | Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Erythema (redness of the skin, due to increased blood flow in the capillaries in the lower layers of theh skin) was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense. | Intent-to-Treat (ITT) Population: all randomized participants who received study product. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Weeks 1, 2, 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Tazorac Cream/Duac Gel | Tazorac (tazarotene 0.1%) cream in evening (PM) and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in morning (AM) daily for topical administration on face | | OG001 | Tazorac Cream/Acanya Gel | Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face |
| | | Title | Denominators | Categories |
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| Week 1, n=19, 17 | | | Title | Measurements |
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| - OG0000.79± 1.03
- OG0010.76± 0.75
|
| | Week 2, n=20, 19 | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | | 0.9597 | | | | | | | 95 | | | | | | No | Superiority or Other | | | | | ANCOVA | | 0.5538 | |
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| Primary | Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12 | Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Dryness was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense. | ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Weeks 1, 2, 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Tazorac Cream/Duac Gel | Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face | | OG001 | Tazorac Cream/Acanya Gel | Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face |
| |
| Primary | Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12 | Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Peeling was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense. | ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Weeks 1, 2, 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Tazorac Cream/Duac Gel | Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face | | OG001 | Tazorac Cream/Acanya Gel | Tazorac (tazarotene 0.1%) cream at PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face |
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| Primary | Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12 | Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Burning/stinging was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities. | ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Weeks 1, 2, 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Tazorac Cream/Duac Gel | Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face | | OG001 | Tazorac Cream/Acanya Gel | Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face |
| |
| Primary | Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12 | Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 6, 8, and 12 minus the value at baseline. Itching was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities. | ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Weeks 1, 2, 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Tazorac Cream/Duac Gel | Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face | | OG001 | Tazorac Cream/Acanya Gel | Tazorac (tazarotene 0.1%) cream at PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face |
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| Primary | Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12 | Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Oiliness was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities. | ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Weeks 1, 2, 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Tazorac Cream/Duac Gel | Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face | | OG001 | Tazorac Cream/Acanya Gel | Tazorac (tazarotene 0.1%) cream at PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face |
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| Primary | Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12 | Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Skin comfort was assessed by participants based on 5-point scale: +2, very comfortable; +1, comfortable; 0, neutral; -1, somewhat uncomfortable; or -2, uncomfortable. | ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Weeks 1, 2, 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Tazorac Cream/Duac Gel | Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face | | OG001 | Tazorac Cream/Acanya Gel | Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face |
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| Secondary | Number of Participants With at Least a Two-grade Improvement in ISGA Score From Baseline to Week 12 | The investigator conducted the overall assessment of the participant's facial acne vulgaris based on the Investigator's Static Global Assessment Scale (ISGA). The ISGA is a 6-point scale: 0, clear skin with no acne vulgaris; 1, almost clear skin; 2, mild; 3, moderate; 4, severe; 5, very severe. | | Posted | | Number | | participants | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Tazorac Cream/Duac Gel | Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face | | OG001 | Tazorac Cream/Acanya Gel | Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face |
| |
| Secondary | Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12 | Inflammation is defined as a localized protective reaction of tissue to irritation, injury, or infection, characterized by pain, redness, swelling, and sometimes loss of function. The investigator counted inflammatory (papules, pustules, and nodules) and non-inflammatory (open and closed comedones) lesions on a participant's face at each study visit. The face is defined as the hairline edge to the mandibular line and should include the forehead, cheeks, and chin. W, Week. | | Posted | | Mean | Standard Deviation | lesions | | Baseline and Weeks 1, 2, 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Tazorac Cream/Duac Gel | Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face | | OG001 | Tazorac Cream/Acanya Gel | Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face |
| |
| Secondary | Mean Change From Baseline in Total Lesion Count at Weeks 1, 2, 4, 8, and 12 | The investigator will count inflammatory (papules, pustules, and nodules) and non-inflammatory (open and closed comedones) lesions on the participant's face at each study visit. The face is defined as the hairline edge to the mandibular line and should include the forehead, cheeks, and chin. | | Posted | | Mean | Standard Deviation | lesions | | Baseline and Weeks 1, 2, 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Tazorac Cream/Duac Gel | Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face | | OG001 | Tazorac Cream/Acanya Gel | Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face |
| |
| Secondary | Mean Change From Baseline for the Global Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12 | Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Global Score is the sum of the 30 question scores; total score ranges from 30 to 150. | ITT Population. Participants with missing baseline values were not included in this analysis. No sunscreen or moisturizer data were collected; thus, there was no analysis of these data. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Tazorac Cream/Duac Gel | Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face | | OG001 | Tazorac Cream/Acanya Gel | Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face |
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| Secondary | Mean Change From Baseline for the Symptomatic Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12 | Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Symptomatic Score is the sum of 7 question scores; total score ranges from 7 to 35. | ITT Population. Participants with missing baseline values were not included in this analysis. No sunscreen or moisturizer data were collected; thus, there was no analysis of these data. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Tazorac Cream/Duac Gel | Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face | | OG001 | Tazorac Cream/Acanya Gel | Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face |
| |
| Secondary | Mean Change From Baseline for the Emotional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12 | Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Emotional Score is the sum of 10 question scores; total score ranges from 10 to 50. | ITT Population. Participants with missing baseline values were not included in this analysis. No sunscreen or moisturizer data were collected; thus, there was no analysis of these data. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Tazorac Cream/Duac Gel | Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face | | OG001 | Tazorac Cream/Acanya Gel | Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face |
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| Secondary | Mean Change From Baseline for the Functional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12 | Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Functional Score is the sum of 12 question scores; total score ranges from 12 to 60. | ITT Population. Participants with missing baseline values were not included in this analysis. No sunscreen or moisturizer data were collected; thus, there was no analysis of these data. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Tazorac Cream/Duac Gel | Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face | | OG001 | Tazorac Cream/Acanya Gel | Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face |
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| Secondary | Overall Satisfaction With Study Product at Week 12 | Overall satisfaction with the study product was assessed from a participant's answer to the following question on the product acceptability and preference questionnaire at the end of study (i.e., Week 12): "What is your overall satisfaction with the study product." Participants assessed overall satisfaction with the study product in the morning and evening, based on a 6-point scale: 1, very satisfied; 2, satisfied; 3, neutral (no opinion); 4, unsatisfied; 5, very unsatisfied. | | Posted | | Mean | Standard Deviation | units on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Tazorac Cream/Duac Gel | Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face | | OG001 | Tazorac Cream/Acanya Gel | Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face |
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