Trial Outcomes & Findings for A Phase 4, Single-Blind, Randomized, Study to Compare the Tolerability and Efficacy of 0.1% Tazorac Cream When Used in Combination With Either Duac Gel or Acanya Gel for the Treatment of Facial Acne Vulgaris (NCT NCT01016977)
NCT ID: NCT01016977
Last Updated: 2017-01-30
Results Overview
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.
COMPLETED
PHASE4
40 participants
Baseline and Weeks 1, 2, 4, 8, and 12
2017-01-30
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
17
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
A Phase 4, Single-Blind, Randomized, Study to Compare the Tolerability and Efficacy of 0.1% Tazorac Cream When Used in Combination With Either Duac Gel or Acanya Gel for the Treatment of Facial Acne Vulgaris
Baseline characteristics by cohort
| Measure |
Tazorac Cream/Duac Gel
n=20 Participants
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
|
Tazorac Cream/Acanya Gel
n=20 Participants
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
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.2 Years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
22.6 Years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
21.9 Years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Gender
Female
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Gender
Male
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 participants
n=5 Participants
|
15 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
9 participants
n=5 Participants
|
4 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Biracial, India, Black, and Phillipino
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiracial (Black, White)
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Weeks 1, 2, 4, 8, and 12Population: 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.
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.
Outcome measures
| Measure |
Tazorac Cream/Duac Gel
n=20 Participants
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
|
Tazorac Cream/Acanya Gel
n=20 Participants
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
|
|---|---|---|
|
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
|
0.76 units on a scale
Standard Deviation 0.75
|
|
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
|
0.47 units on a scale
Standard Deviation 0.70
|
|
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
|
0.55 units on a scale
Standard Deviation 0.76
|
|
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
|
0.20 units on a scale
Standard Deviation 0.52
|
|
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
|
0.10 units on a scale
Standard Deviation 0.79
|
PRIMARY outcome
Timeframe: Baseline and Weeks 1, 2, 4, 8, and 12Population: 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.
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.
Outcome measures
| Measure |
Tazorac Cream/Duac Gel
n=20 Participants
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
|
Tazorac Cream/Acanya Gel
n=20 Participants
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
|
|---|---|---|
|
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
|
0.15 units on a scale
Standard Deviation 0.59
|
|
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 0.70
|
-0.05 units on a scale
Standard Deviation 0.51
|
|
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
|
1.18 units on a scale
Standard Deviation 0.81
|
|
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
|
0.84 units on a scale
Standard Deviation 0.96
|
|
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
|
0.55 units on a scale
Standard Deviation 0.83
|
PRIMARY outcome
Timeframe: Baseline and Weeks 1, 2, 4, 8, and 12Population: 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.
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.
Outcome measures
| Measure |
Tazorac Cream/Duac Gel
n=20 Participants
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
|
Tazorac Cream/Acanya Gel
n=20 Participants
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
|
|---|---|---|
|
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
|
0.10 units on a scale
Standard Deviation 0.55
|
|
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
|
1.06 units on a scale
Standard Deviation 0.83
|
|
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
|
0.79 units on a scale
Standard Deviation 0.98
|
|
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
|
0.55 units on a scale
Standard Deviation 0.83
|
|
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 0.70
|
-0.05 units on a scale
Standard Deviation 0.51
|
PRIMARY outcome
Timeframe: Baseline and Weeks 1, 2, 4, 8, and 12Population: 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.
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.
Outcome measures
| Measure |
Tazorac Cream/Duac Gel
n=20 Participants
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
|
Tazorac Cream/Acanya Gel
n=20 Participants
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
|
|---|---|---|
|
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
|
0.84 units on a scale
Standard Deviation 1.07
|
|
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
|
1.65 units on a scale
Standard Deviation 1.69
|
|
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
|
0.55 units on a scale
Standard Deviation 0.76
|
|
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
|
0.45 units on a scale
Standard Deviation 0.69
|
|
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 1.40
|
0.40 units on a scale
Standard Deviation 0.82
|
PRIMARY outcome
Timeframe: Baseline and Weeks 1, 2, 4, 8, and 12Population: 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.
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.
Outcome measures
| Measure |
Tazorac Cream/Duac Gel
n=20 Participants
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
|
Tazorac Cream/Acanya Gel
n=20 Participants
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
|
|---|---|---|
|
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
|
0.76 units on a scale
Standard Deviation 1.64
|
|
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
|
0.84 units on a scale
Standard Deviation 1.38
|
|
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 1.20
|
0.65 units on a scale
Standard Deviation 1.18
|
|
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
|
0.30 units on a scale
Standard Deviation 0.80
|
|
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
|
0.45 units on a scale
Standard Deviation 1.47
|
PRIMARY outcome
Timeframe: Baseline and Weeks 1, 2, 4, 8, and 12Population: 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.
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.
Outcome measures
| Measure |
Tazorac Cream/Duac Gel
n=20 Participants
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
|
Tazorac Cream/Acanya Gel
n=20 Participants
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
|
|---|---|---|
|
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 1.60
|
-1.29 units on a scale
Standard Deviation 1.40
|
|
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
|
-1.05 units on a scale
Standard Deviation 1.35
|
|
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
|
-0.55 units on a scale
Standard Deviation 1.85
|
|
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
|
-1.05 units on a scale
Standard Deviation 1.39
|
|
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
|
-0.75 units on a scale
Standard Deviation 1.97
|
PRIMARY outcome
Timeframe: Baseline and Weeks 1, 2, 4, 8, and 12Population: 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.
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.
Outcome measures
| Measure |
Tazorac Cream/Duac Gel
n=20 Participants
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
|
Tazorac Cream/Acanya Gel
n=20 Participants
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
|
|---|---|---|
|
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
|
0.60 units on a scale
Standard Deviation 0.99
|
|
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
|
-0.29 units on a scale
Standard Deviation 0.92
|
|
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
|
0.05 units on a scale
Standard Deviation 0.91
|
|
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
|
-0.10 units on a scale
Standard Deviation 0.85
|
|
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
|
0.10 units on a scale
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT Population
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.
Outcome measures
| Measure |
Tazorac Cream/Duac Gel
n=20 Participants
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
|
Tazorac Cream/Acanya Gel
n=20 Participants
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
|
|---|---|---|
|
Number of Participants With at Least a Two-grade Improvement in ISGA Score From Baseline to Week 12
|
7 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 2, 4, 8, and 12Population: ITT Population
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.
Outcome measures
| Measure |
Tazorac Cream/Duac Gel
n=20 Participants
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
|
Tazorac Cream/Acanya Gel
n=20 Participants
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
|
|---|---|---|
|
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
|
-5.9 lesions
Standard Deviation 6.1
|
|
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
|
-8.1 lesions
Standard Deviation 6.3
|
|
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
|
-9.6 lesions
Standard Deviation 9.2
|
|
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
|
-16.3 lesions
Standard Deviation 5.7
|
|
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
|
-13.4 lesions
Standard Deviation 13.6
|
|
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
|
-7.6 lesions
Standard Deviation 7.1
|
|
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
|
-15.1 lesions
Standard Deviation 11.4
|
|
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
|
-26.6 lesions
Standard Deviation 13.2
|
|
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
|
-33.1 lesions
Standard Deviation 17.3
|
|
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
|
-37.8 lesions
Standard Deviation 21.4
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 2, 4, 8, and 12Population: ITT Population
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.
Outcome measures
| Measure |
Tazorac Cream/Duac Gel
n=20 Participants
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
|
Tazorac Cream/Acanya Gel
n=20 Participants
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
|
|---|---|---|
|
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 14.0
|
-13.5 lesions
Standard Deviation 9.4
|
|
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
|
-23.1 lesions
Standard Deviation 14.5
|
|
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
|
-36.2 lesions
Standard Deviation 15.4
|
|
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
|
-49.4 lesions
Standard Deviation 20.2
|
|
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
|
-51.1 lesions
Standard Deviation 27.8
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Tazorac Cream/Duac Gel
n=18 Participants
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
|
Tazorac Cream/Acanya Gel
n=19 Participants
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
|
|---|---|---|
|
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
|
-3.7 units on a scale
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Tazorac Cream/Duac Gel
n=18 Participants
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
|
Tazorac Cream/Acanya Gel
n=19 Participants
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
|
|---|---|---|
|
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
|
-1.4 units on a scale
Standard Deviation 13.5
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Tazorac Cream/Duac Gel
n=18 Participants
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
|
Tazorac Cream/Acanya Gel
n=19 Participants
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
|
|---|---|---|
|
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
|
-7.1 units on a scale
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Tazorac Cream/Duac Gel
n=18 Participants
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
|
Tazorac Cream/Acanya Gel
n=19 Participants
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
|
|---|---|---|
|
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
|
-3.7 units on a scale
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: Week 12Population: ITT Population
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.
Outcome measures
| Measure |
Tazorac Cream/Duac Gel
n=20 Participants
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
|
Tazorac Cream/Acanya Gel
n=20 Participants
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
|
|---|---|---|
|
Overall Satisfaction With Study Product at Week 12
Morning
|
1.76 units on a scale
Standard Deviation 1.15
|
1.75 units on a scale
Standard Deviation 0.72
|
|
Overall Satisfaction With Study Product at Week 12
Evening
|
1.59 units on a scale
Standard Deviation 1.00
|
1.70 units on a scale
Standard Deviation 0.92
|
Adverse Events
Tazorac Cream/Duac Gel
Tazorac Cream/Acanya Gel
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tazorac Cream/Duac Gel
n=20 participants at risk
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
|
Tazorac Cream/Acanya Gel
n=20 participants at risk
Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
30.0%
6/20
|
30.0%
6/20
|
|
Infections and infestations
Bacterial Infection
|
5.0%
1/20
|
0.00%
0/20
|
|
Infections and infestations
Influenza
|
5.0%
1/20
|
0.00%
0/20
|
|
Infections and infestations
Viral Infection
|
0.00%
0/20
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
10.0%
2/20
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/20
|
5.0%
1/20
|
|
General disorders
Application Site Erythema
|
5.0%
1/20
|
0.00%
0/20
|
|
General disorders
Application Site Irritation
|
5.0%
1/20
|
0.00%
0/20
|
|
General disorders
Pyrexia
|
5.0%
1/20
|
0.00%
0/20
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/20
|
5.0%
1/20
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER