Acne Vulgaris
Conditions
Brief summary
A single-blind (investigator-blinded), randomized, parallel group, single center study to evaluate the tolerability and efficacy of combination therapy with Duac Gel / 0.1% Tazorac Cream and Acanya Gel / 0.1% Tazorac Cream for the treatment of facial acne vulgaris.
Detailed description
This is a single-blind (investigator-blinded), randomized, parallel group, single center study to evaluate the tolerability and efficacy of combination therapy with Duac Gel/Tazorac Cream and Acanya Gel/Tazorac Cream for the treatment of facial acne vulgaris. Approximately 40 male and female subjects will be enrolled (20 per study group). Subjects will participate in the study for 12 weeks; visits will be scheduled at baseline and at weeks 1, 2, 4, 8, and 12 (total of 6 visits). Eligible subjects will be randomized at baseline to 1 of the 2 study groups in a 1:1 ratio (Duac Gel/Tazorac Cream to Acanya Gel/Tazorac Cream). Subjects will apply either Duac Gel or Acanya Gel to the face each morning and apply Tazorac Cream to the face each evening. Tolerability will be evaluated through subject assessments of burning/stinging, itching, and oiliness and through investigator assessments of peeling, erythema, and dryness. In addition, subjects will evaluate their overall skin comfort and record the usage of moisturizer and sunscreen, if needed. Efficacy will be assessed through lesion counts (total, inflammatory and noninflammatory) and ISGA. Safety will be assessed by evaluating adverse events (AEs), concomitant medication use, and withdrawals from the study. This is an investigator-blinded study; therefore, subjects and study-center staff will not be blinded to study treatment allocation. Subjects (and parents or legal guardians) and study-center staff will be instructed not to reveal study product allocation to the investigator.
Interventions
DRUGClindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene
Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene
DRUGclindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene
clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene
Sponsors
GlaxoSmithKline
Stiefel, a GSK Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Documented diagnosis of acne vulgaris. * Lesion count: 20 to 50 inflammatory (papules and pustules) and 30 to 100 noninflammatory (open and closed - comedones) facial lesions excluding nose, and ≤ 1 small nodular lesion. Cystic lesions are not allowed at baseline. * Investigator Static Global Assessment of 3 or 4 at Baseline.
Exclusion criteria
* Clinically relevant finding at baseline or medical history of severe systemic diseases or diseases of the facial skin, other than acne vulgaris. * Subjects with cystic acne lesions. * Facial hair that may obscure the accurate assessment of acne grade. * History or presence of regional enteritis or inflammatory bowel disease (eg, ulcerative colitis, pseudomembranous colitis, chronic diarrhea, celiac disease or a history of antibiotic-associated colitis) or similar symptoms. * Concurrent use of medications known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, and sulfonamides) because of the possibility of increased phototoxicity. * Concomitant use of neuromuscular blocking agents. Clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents. * Use of topical anti-acne medications (eg, benzoyl peroxide, retinoids, azelaic acid, resorcinol, salicylates, sulfacetamide sodium and derivatives, and glycolic acid) within the past 2 weeks. * Use of topical antibiotics on the face within the past 2 weeks or systemic antibiotics within the past 4 weeks. * Use of topical corticosteroids on the face or systemic corticosteroids within the past 2 to 4 weeks, respectively. Use of inhaled, intra-articular or intra lesional (other than for facial acne lesions) steroids is acceptable. * Use of systemic retinoids, such as Isotretinoin, within the past 6 months. * Concomitant use of the following types of facial products: astringents, toners, abradants, hair removal wax, facials, peels containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide, sulfacetamide sodium or salicylic acid, non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or α- or β hydroxy acids. * Concomitant use of medications that are reported to exacerbate acne, (eg, vitamins such as vitamin D, vitamin A, vitamins B2, B6, B12; haloperidol, halogens such as iodide and bromide, lithium, cyclosporine, psoralen, sirolimus, imatinib, aripiprazole, isoniazid, valproate acid, hydantoin, and phenobarbital) as these may impact efficacy assessments. Iron supplements and folate are acceptable. * Facial procedures (eg, chemical peel, lasers/lights, photodynamic therapy, microdermabrasion, artificial ultraviolet therapy) performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks. * Known hypersensitivity or previous allergic reaction to any component(s) or excipient(s) of the study products. * Use of any investigational medications or treatments within the past 4 weeks. * Treatment with estrogens, including oral, implanted and topical contraceptives, androgens, or anti-androgenic agents for 12 weeks or less immediately prior to starting study product and have not been prescribed for the treatment of Acne Vulgaris. Subjects that have been treated with estrogens, as described above, androgens, or anti androgenic agents for more than 12 consecutive weeks prior to start of study treatment are allowed to enroll as long as they do not expect to change dose, medication, or discontinue use during the study. * Evidence of recent alcohol or drug abuse (in the opinion of the investigator). * Live in the same household as currently enrolled subjects. * Employee of the investigator, a clinical research organization, or Stiefel Laboratories who is involved in the study or an immediate family member (eg, partner, offspring, parents, siblings or sibling's offspring) of an employee involved in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12 | Baseline and 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. |
| Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12 | Baseline and 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. |
| Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12 | Baseline and 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. |
| Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12 | Baseline and 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. |
| Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12 | Baseline and 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. |
| Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12 | Baseline and 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. |
| Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12 | Baseline and 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With at Least a Two-grade Improvement in ISGA Score From Baseline to Week 12 | Baseline and 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. |
| Overall Satisfaction With Study Product at Week 12 | 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. |
| Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12 | Baseline and 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. |
| Mean Change From Baseline in Total Lesion Count at Weeks 1, 2, 4, 8, and 12 | Baseline and 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. |
| Mean Change From Baseline for the Global Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12 | Baseline and 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. |
| Mean Change From Baseline for the Symptomatic Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12 | Baseline and 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. |
| Mean Change From Baseline for the Emotional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12 | Baseline and 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. |
| Mean Change From Baseline for the Functional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12 | Baseline and 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| 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 | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Total | Tazorac Cream/Duac Gel | Tazorac Cream/Acanya Gel |
|---|---|---|---|
| Age, Continuous | 21.9 Years STANDARD_DEVIATION 8.3 | 21.2 Years STANDARD_DEVIATION 9 | 22.6 Years STANDARD_DEVIATION 7.8 |
| Gender Female | 22 Participants | 13 Participants | 9 Participants |
| Gender Male | 18 Participants | 7 Participants | 11 Participants |
| Race/Ethnicity, Customized Asian | 23 participants | 8 participants | 15 participants |
| Race/Ethnicity, Customized Biracial, India, Black, and Phillipino | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Black | 2 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Multiracial (Black, White) | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized White | 13 participants | 9 participants | 4 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 20 | 7 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: Baseline and Weeks 1, 2, 4, 8, and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12 | Week 2, n=20, 19 | 0.70 units on a scale | Standard Deviation 1.59 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12 | Week 8, n=20, 20 | 0.60 units on a scale | Standard Deviation 1.27 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12 | Week 4, n=20, 20 | 1.25 units on a scale | Standard Deviation 1.92 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12 | Week 12, n=20, 20 | 0.50 units on a scale | Standard Deviation 1.4 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12 | Week 1, n=19, 17 | 1.58 units on a scale | Standard Deviation 1.87 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12 | Week 12, n=20, 20 | 0.40 units on a scale | Standard Deviation 0.82 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12 | Week 1, n=19, 17 | 1.65 units on a scale | Standard Deviation 1.69 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12 | Week 2, n=20, 19 | 0.84 units on a scale | Standard Deviation 1.07 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12 | Week 4, n=20, 20 | 0.55 units on a scale | Standard Deviation 0.76 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12 | Week 8, n=20, 20 | 0.45 units on a scale | Standard Deviation 0.69 |
p-value: 0.7546ANCOVA
p-value: 0.7705ANCOVA
p-value: 0.0259ANCOVA
p-value: 0.9252ANCOVA
p-value: 0.2927ANCOVA
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.
Time frame: Baseline and Weeks 1, 2, 4, 8, and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12 | Week 1, n=19, 17 | 1.11 units on a scale | Standard Deviation 1.05 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12 | Week 2, n=20, 19 | 1.15 units on a scale | Standard Deviation 0.81 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12 | Week 4, n=20, 20 | 0.65 units on a scale | Standard Deviation 0.75 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12 | Week 8, n=20, 20 | 0.50 units on a scale | Standard Deviation 0.95 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12 | Week 12, n=20, 20 | 0.20 units on a scale | Standard Deviation 0.7 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12 | Week 12, n=20, 20 | -0.05 units on a scale | Standard Deviation 0.51 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12 | Week 1, n=19, 17 | 1.18 units on a scale | Standard Deviation 0.81 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12 | Week 8, n=20, 20 | 0.15 units on a scale | Standard Deviation 0.59 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12 | Week 4, n=20, 20 | 0.55 units on a scale | Standard Deviation 0.83 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12 | Week 2, n=20, 19 | 0.84 units on a scale | Standard Deviation 0.96 |
p-value: 0.5961ANCOVA
p-value: 0.2293ANCOVA
p-value: 0.9852ANCOVA
p-value: 0.5538ANCOVA
p-value: 0.654ANCOVA
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.
Time frame: Baseline and Weeks 1, 2, 4, 8, and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12 | Week 2, n=20, 19 | 0.60 units on a scale | Standard Deviation 0.82 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12 | Week 8, n=20, 20 | 0.20 units on a scale | Standard Deviation 0.62 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12 | Week 4, n=20, 20 | 0.50 units on a scale | Standard Deviation 0.89 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12 | Week 12, n=20, 20 | 0.25 units on a scale | Standard Deviation 0.64 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12 | Week 1, n=19, 17 | 0.79 units on a scale | Standard Deviation 1.03 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12 | Week 12, n=20, 20 | 0.10 units on a scale | Standard Deviation 0.79 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12 | Week 1, n=19, 17 | 0.76 units on a scale | Standard Deviation 0.75 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12 | Week 2, n=20, 19 | 0.47 units on a scale | Standard Deviation 0.7 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12 | Week 4, n=20, 20 | 0.55 units on a scale | Standard Deviation 0.76 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12 | Week 8, n=20, 20 | 0.20 units on a scale | Standard Deviation 0.52 |
p-value: 0.9597ANCOVA
p-value: 0.5538ANCOVA
p-value: 0.6315ANCOVA
p-value: 0.5655ANCOVA
p-value: 0.7917ANCOVA
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.
Time frame: Baseline and Weeks 1, 2, 4, 8, and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12 | Week 4, n=20, 20 | 0.20 units on a scale | Standard Deviation 1.2 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12 | Week 2, n=20, 19 | 0.10 units on a scale | Standard Deviation 0.79 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12 | Week 8, n=20, 20 | -0.05 units on a scale | Standard Deviation 1.15 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12 | Week 12, n=20, 20 | 0.35 units on a scale | Standard Deviation 1.42 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12 | Week 1, n=19, 17 | 0.68 units on a scale | Standard Deviation 1.57 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12 | Week 12, n=20, 20 | 0.45 units on a scale | Standard Deviation 1.47 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12 | Week 1, n=19, 17 | 0.76 units on a scale | Standard Deviation 1.64 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12 | Week 8, n=20, 20 | 0.30 units on a scale | Standard Deviation 0.8 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12 | Week 2, n=20, 19 | 0.84 units on a scale | Standard Deviation 1.38 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12 | Week 4, n=20, 20 | 0.65 units on a scale | Standard Deviation 1.18 |
p-value: 0.401ANCOVA
p-value: 0.0963ANCOVA
p-value: 0.9291ANCOVA
p-value: 0.5523ANCOVA
p-value: 0.2556ANCOVA
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.
Time frame: Baseline and Weeks 1, 2, 4, 8, and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12 | Week 2, n=20, 19 | -0.95 units on a scale | Standard Deviation 1.61 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12 | Week 8, n=20, 20 | -0.80 units on a scale | Standard Deviation 1.79 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12 | Week 4, n=20, 20 | -0.85 units on a scale | Standard Deviation 1.87 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12 | Week 12, n=20, 20 | -0.35 units on a scale | Standard Deviation 1.84 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12 | Week 1, n=19, 17 | -1.00 units on a scale | Standard Deviation 1.6 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12 | Week 12, n=20, 20 | -0.75 units on a scale | Standard Deviation 1.97 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12 | Week 1, n=19, 17 | -1.29 units on a scale | Standard Deviation 1.4 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12 | Week 2, n=20, 19 | -1.05 units on a scale | Standard Deviation 1.35 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12 | Week 4, n=20, 20 | -0.55 units on a scale | Standard Deviation 1.85 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12 | Week 8, n=20, 20 | -1.05 units on a scale | Standard Deviation 1.39 |
p-value: 0.4037ANCOVA
p-value: 0.8662ANCOVA
p-value: 0.5951ANCOVA
p-value: 0.2349ANCOVA
p-value: 0.3461ANCOVA
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.
Time frame: Baseline and Weeks 1, 2, 4, 8, and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12 | Week 2, n=20, 19 | 1.05 units on a scale | Standard Deviation 0.83 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12 | Week 8, n=20, 20 | 0.50 units on a scale | Standard Deviation 0.95 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12 | Week 4, n=20, 20 | 0.60 units on a scale | Standard Deviation 0.75 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12 | Week 12, n=20, 20 | 0.20 units on a scale | Standard Deviation 0.7 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12 | Week 1, n=19, 17 | 1.11 units on a scale | Standard Deviation 1.05 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12 | Week 12, n=20, 20 | -0.05 units on a scale | Standard Deviation 0.51 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12 | Week 1, n=19, 17 | 1.06 units on a scale | Standard Deviation 0.83 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12 | Week 2, n=20, 19 | 0.79 units on a scale | Standard Deviation 0.98 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12 | Week 4, n=20, 20 | 0.55 units on a scale | Standard Deviation 0.83 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12 | Week 8, n=20, 20 | 0.10 units on a scale | Standard Deviation 0.55 |
p-value: 0.8545ANCOVA
p-value: 0.2895ANCOVA
p-value: 0.8234ANCOVA
p-value: 0.3644ANCOVA
p-value: 0.654ANCOVA
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.
Time frame: Baseline and Weeks 1, 2, 4, 8, and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12 | Week 2, n=20, 19 | 0.25 units on a scale | Standard Deviation 1.45 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12 | Week 8, n=20, 20 | 0.30 units on a scale | Standard Deviation 1.17 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12 | Week 4, n=20, 20 | 0.05 units on a scale | Standard Deviation 1.23 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12 | Week 12, n=20, 20 | 0.45 units on a scale | Standard Deviation 1.39 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12 | Week 1, n=19, 17 | -0.37 units on a scale | Standard Deviation 1.54 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12 | Week 12, n=20, 20 | 0.60 units on a scale | Standard Deviation 0.99 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12 | Week 1, n=19, 17 | -0.29 units on a scale | Standard Deviation 0.92 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12 | Week 2, n=20, 19 | 0.05 units on a scale | Standard Deviation 0.91 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12 | Week 4, n=20, 20 | -0.10 units on a scale | Standard Deviation 0.85 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12 | Week 8, n=20, 20 | 0.10 units on a scale | Standard Deviation 0.85 |
p-value: 0.1679ANCOVA
p-value: 0.725ANCOVA
p-value: 0.9743ANCOVA
p-value: 0.9816ANCOVA
p-value: 0.8809ANCOVA
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.
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tazorac Cream/Duac Gel | Mean Change From Baseline for the Emotional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12 | -11.2 units on a scale | Standard Deviation 11.8 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline for the Emotional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12 | -7.1 units on a scale | Standard Deviation 8.9 |
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.
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tazorac Cream/Duac Gel | Mean Change From Baseline for the Functional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12 | -6.1 units on a scale | Standard Deviation 11.6 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline for the Functional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12 | -3.7 units on a scale | Standard Deviation 8.4 |
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.
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tazorac Cream/Duac Gel | Mean Change From Baseline for the Global Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12 | -6.1 units on a scale | Standard Deviation 11.6 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline for the Global Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12 | -3.7 units on a scale | Standard Deviation 8.4 |
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.
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tazorac Cream/Duac Gel | Mean Change From Baseline for the Symptomatic Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12 | -8.7 units on a scale | Standard Deviation 15.7 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline for the Symptomatic Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12 | -1.4 units on a scale | Standard Deviation 13.5 |
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.
Time frame: Baseline and Weeks 1, 2, 4, 8, and 12
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12 | W1, Inflammatory lesions, n=19, 17 | -6.6 lesions | Standard Deviation 5.3 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12 | W2, Inflammatory lesions, n=20, 19 | -8.8 lesions | Standard Deviation 8.7 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12 | W4, Inflammatory lesions, n=20, 20 | -13.0 lesions | Standard Deviation 6.3 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12 | W8, Inflammatory lesions, n=20, 20 | -14.9 lesions | Standard Deviation 7.2 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12 | W12, Inflammatory lesions, n=20, 20 | -18.0 lesions | Standard Deviation 6.6 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12 | W1, Non-inflammatory lesions, n=19, 17 | -3.2 lesions | Standard Deviation 11.2 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12 | W2, Non-inflammatory lesions, n=20, 19 | -17.9 lesions | Standard Deviation 11.4 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12 | W4, Non-inflammatory lesions, n=20, 20 | -23.6 lesions | Standard Deviation 13.6 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12 | W8, Non-inflammatory lesions, n=20, 20 | -28.9 lesions | Standard Deviation 19.1 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12 | W12, Non-inflammatory lesions, n=20, 20 | -32.6 lesions | Standard Deviation 19.4 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12 | W4, Non-inflammatory lesions, n=20, 20 | -26.6 lesions | Standard Deviation 13.2 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12 | W1, Inflammatory lesions, n=19, 17 | -5.9 lesions | Standard Deviation 6.1 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12 | W1, Non-inflammatory lesions, n=19, 17 | -7.6 lesions | Standard Deviation 7.1 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12 | W2, Inflammatory lesions, n=20, 19 | -8.1 lesions | Standard Deviation 6.3 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12 | W12, Non-inflammatory lesions, n=20, 20 | -37.8 lesions | Standard Deviation 21.4 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12 | W4, Inflammatory lesions, n=20, 20 | -9.6 lesions | Standard Deviation 9.2 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12 | W2, Non-inflammatory lesions, n=20, 19 | -15.1 lesions | Standard Deviation 11.4 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12 | W8, Inflammatory lesions, n=20, 20 | -16.3 lesions | Standard Deviation 5.7 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12 | W8, Non-inflammatory lesions, n=20, 20 | -33.1 lesions | Standard Deviation 17.3 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12 | W12, Inflammatory lesions, n=20, 20 | -13.4 lesions | Standard Deviation 13.6 |
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.
Time frame: Baseline and Weeks 1, 2, 4, 8, and 12
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Total Lesion Count at Weeks 1, 2, 4, 8, and 12 | Week 12, n=20, 20 | -50.6 lesions | Standard Deviation 23.1 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Total Lesion Count at Weeks 1, 2, 4, 8, and 12 | Week 1, n=19, 17 | -9.8 lesions | Standard Deviation 14 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Total Lesion Count at Weeks 1, 2, 4, 8, and 12 | Week 2, n=20, 19 | -26.6 lesions | Standard Deviation 15.3 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Total Lesion Count at Weeks 1, 2, 4, 8, and 12 | Week 4, n=20, 20 | -36.6 lesions | Standard Deviation 15.4 |
| Tazorac Cream/Duac Gel | Mean Change From Baseline in Total Lesion Count at Weeks 1, 2, 4, 8, and 12 | Week 8, n=20, 20 | -43.7 lesions | Standard Deviation 23.5 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Total Lesion Count at Weeks 1, 2, 4, 8, and 12 | Week 8, n=20, 20 | -49.4 lesions | Standard Deviation 20.2 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Total Lesion Count at Weeks 1, 2, 4, 8, and 12 | Week 4, n=20, 20 | -36.2 lesions | Standard Deviation 15.4 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Total Lesion Count at Weeks 1, 2, 4, 8, and 12 | Week 1, n=19, 17 | -13.5 lesions | Standard Deviation 9.4 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Total Lesion Count at Weeks 1, 2, 4, 8, and 12 | Week 12, n=20, 20 | -51.1 lesions | Standard Deviation 27.8 |
| Tazorac Cream/Acanya Gel | Mean Change From Baseline in Total Lesion Count at Weeks 1, 2, 4, 8, and 12 | Week 2, n=20, 19 | -23.1 lesions | Standard Deviation 14.5 |
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.
Time frame: Baseline and Week 12
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tazorac Cream/Duac Gel | Number of Participants With at Least a Two-grade Improvement in ISGA Score From Baseline to Week 12 | 7 participants |
| Tazorac Cream/Acanya Gel | Number of Participants With at Least a Two-grade Improvement in ISGA Score From Baseline to Week 12 | 10 participants |
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.
Time frame: Week 12
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tazorac Cream/Duac Gel | Overall Satisfaction With Study Product at Week 12 | Morning | 1.76 units on a scale | Standard Deviation 1.15 |
| Tazorac Cream/Duac Gel | Overall Satisfaction With Study Product at Week 12 | Evening | 1.59 units on a scale | Standard Deviation 1 |
| Tazorac Cream/Acanya Gel | Overall Satisfaction With Study Product at Week 12 | Morning | 1.75 units on a scale | Standard Deviation 0.72 |
| Tazorac Cream/Acanya Gel | Overall Satisfaction With Study Product at Week 12 | Evening | 1.70 units on a scale | Standard Deviation 0.92 |