Trial Outcomes & Findings for Two-week Study to Compare the Tolerance and Irritation Potential of Two Combination Topical Gel Acne Medications (NCT NCT00926367)
NCT ID: NCT00926367
Last Updated: 2015-05-20
Results Overview
Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below. Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
52 participants
Primary outcome timeframe
Baseline, Day 1 through Day 14
Results posted on
2015-05-20
Participant Flow
Clinical research center.
Panelists who met the eligibility criteria and were willing to participate in the study were required to undergo a 3-day pre-trial conditioning period where they had to stop the use of all facial products. Panelists were required to use the provided Soap Free Cleanser (SFC) for washing their face and were allowed to apply their normal makeup.
Participant milestones
| Measure |
Duac
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
|
Epiduo
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
27
|
|
Overall Study
COMPLETED
|
23
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Duac
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
|
Epiduo
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Skin Irritation
|
1
|
2
|
Baseline Characteristics
Two-week Study to Compare the Tolerance and Irritation Potential of Two Combination Topical Gel Acne Medications
Baseline characteristics by cohort
| Measure |
Duac
n=25 Participants
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
|
Epiduo
n=27 Participants
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
27 participants
n=7 Participants
|
52 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 1 through Day 14Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below. Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion
Outcome measures
| Measure |
Duac
n=25 Participants
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
|
Epiduo
n=27 Participants
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
|
|---|---|---|
|
Skin Erythema (Redness)
Baseline
|
1.56 Units on a scale
Standard Deviation 0.92
|
1.89 Units on a scale
Standard Deviation 1.01
|
|
Skin Erythema (Redness)
Day 1
|
2.62 Units on a scale
Standard Deviation 1.32
|
2.65 Units on a scale
Standard Deviation 0.94
|
|
Skin Erythema (Redness)
Day 2
|
2.90 Units on a scale
Standard Deviation 1.23
|
2.52 Units on a scale
Standard Deviation 1.03
|
|
Skin Erythema (Redness)
Day 3
|
3.08 Units on a scale
Standard Deviation 1.23
|
2.81 Units on a scale
Standard Deviation 1.02
|
|
Skin Erythema (Redness)
Day 6
|
3.17 Units on a scale
Standard Deviation 1.33
|
3.13 Units on a scale
Standard Deviation 0.89
|
|
Skin Erythema (Redness)
Day 7
|
3.07 Units on a scale
Standard Deviation 1.30
|
3.08 Units on a scale
Standard Deviation 1.01
|
|
Skin Erythema (Redness)
Day 8
|
2.87 Units on a scale
Standard Deviation 1.24
|
2.98 Units on a scale
Standard Deviation 1.08
|
|
Skin Erythema (Redness)
Day 9
|
2.78 Units on a scale
Standard Deviation 1.36
|
3.03 Units on a scale
Standard Deviation 0.99
|
|
Skin Erythema (Redness)
Day 10
|
2.89 Units on a scale
Standard Deviation 1.22
|
2.94 Units on a scale
Standard Deviation 1.02
|
|
Skin Erythema (Redness)
Day 13
|
2.85 Units on a scale
Standard Deviation 1.20
|
2.83 Units on a scale
Standard Deviation 1.21
|
|
Skin Erythema (Redness)
Day 14
|
2.73 Units on a scale
Standard Deviation 1.20
|
2.56 Units on a scale
Standard Deviation 1.03
|
PRIMARY outcome
Timeframe: Baseline, Day 1 through Day 14The amount of dryness on the left and right cheek of each panelist. The scale used to evaluate skin dryness is: Grade Description 0 None 2 Slight flaking 4 Moderate flaking/scaling 6 Marked scaling / slight fissuring 8 Severe scaling, fissuring Expert Grader assessments of dryness were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Outcome measures
| Measure |
Duac
n=25 Participants
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
|
Epiduo
n=27 Participants
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
|
|---|---|---|
|
Skin Dryness
Baseline
|
0.12 units on a scale
Standard Deviation 0.44
|
0.07 units on a scale
Standard Deviation 0.27
|
|
Skin Dryness
Day 1
|
0.41 units on a scale
Standard Deviation 0.85
|
0.25 units on a scale
Standard Deviation 0.57
|
|
Skin Dryness
Day 2
|
0.32 units on a scale
Standard Deviation 0.83
|
0.34 units on a scale
Standard Deviation 0.59
|
|
Skin Dryness
Day 3
|
0.46 units on a scale
Standard Deviation 0.91
|
0.55 units on a scale
Standard Deviation 1.15
|
|
Skin Dryness
Day 6
|
0.61 units on a scale
Standard Deviation 1.02
|
1.73 units on a scale
Standard Deviation 1.76
|
|
Skin Dryness
Day 7
|
0.69 units on a scale
Standard Deviation 1.16
|
1.85 units on a scale
Standard Deviation 2.01
|
|
Skin Dryness
Day 8
|
0.60 units on a scale
Standard Deviation 1.13
|
1.87 units on a scale
Standard Deviation 2.04
|
|
Skin Dryness
Day 9
|
0.73 units on a scale
Standard Deviation 1.28
|
2.29 units on a scale
Standard Deviation 1.99
|
|
Skin Dryness
Day 10
|
0.56 units on a scale
Standard Deviation 1.04
|
1.49 units on a scale
Standard Deviation 1.77
|
|
Skin Dryness
Day 13
|
0.80 units on a scale
Standard Deviation 1.33
|
1.26 units on a scale
Standard Deviation 1.85
|
|
Skin Dryness
Day 14
|
0.79 units on a scale
Standard Deviation 1.04
|
1.33 units on a scale
Standard Deviation 1.75
|
SECONDARY outcome
Timeframe: Baseline, Days 3, 7, and 14To assess skin moisture and hydration using transepidermal water loss (TEWL). Results are measured on a continuous scale. Higher values indicate greater water loss/ lower skin moisture levels. Evaporative water loss measurements provide an instrumental assessment of skin barrier function(one of the layers of the skin. Damage leads to a disruption of the barrier that is accompanied by elevated water loss rates and affects skin moisture and hydration. Higher values indicate greater water loss.
Outcome measures
| Measure |
Duac
n=25 Participants
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
|
Epiduo
n=27 Participants
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
|
|---|---|---|
|
Skin Moisture and Hydration
Baseline
|
11.50 TEWL rates (gm/m2/hr)
Standard Deviation 3.65
|
13.07 TEWL rates (gm/m2/hr)
Standard Deviation 5.06
|
|
Skin Moisture and Hydration
Day 3
|
11.38 TEWL rates (gm/m2/hr)
Standard Deviation 2.49
|
15.85 TEWL rates (gm/m2/hr)
Standard Deviation 9.12
|
|
Skin Moisture and Hydration
Day 7
|
14.51 TEWL rates (gm/m2/hr)
Standard Deviation 3.65
|
21.65 TEWL rates (gm/m2/hr)
Standard Deviation 8.66
|
|
Skin Moisture and Hydration
Day 14
|
13.36 TEWL rates (gm/m2/hr)
Standard Deviation 3.33
|
19.28 TEWL rates (gm/m2/hr)
Standard Deviation 8.10
|
SECONDARY outcome
Timeframe: Baseline, 4 hrs. post 1st Treatment, Days 3, 7, and 14The ability of an alternating current to flow through the stratum corneum is an indirect measure of its water content. The value recorded is expressed in microsiemens. Higher values indicate greater levels of skin hydration. Test results were compared to measurements from the other side of the face, which was not treated instead of referring to a normal range. A normal range does not exist for this measurement. Instead, the non-treated side of the face was used as a control to determine the normal level of skin hydration.
Outcome measures
| Measure |
Duac
n=25 Participants
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
|
Epiduo
n=27 Participants
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
|
|---|---|---|
|
Skin Hydration
Baseline
|
378.06 Microsiemens
Standard Deviation 131.08
|
392.09 Microsiemens
Standard Deviation 162.16
|
|
Skin Hydration
4 hrs Post 1st Treatment
|
323.47 Microsiemens
Standard Deviation 154.30
|
415.90 Microsiemens
Standard Deviation 197.57
|
|
Skin Hydration
Day 3
|
420.97 Microsiemens
Standard Deviation 122.60
|
465.25 Microsiemens
Standard Deviation 175.65
|
|
Skin Hydration
Day 7
|
385.91 Microsiemens
Standard Deviation 156.69
|
414.77 Microsiemens
Standard Deviation 154.46
|
|
Skin Hydration
Day 14
|
401.98 Microsiemens
Standard Deviation 156.08
|
418.51 Microsiemens
Standard Deviation 139.64
|
SECONDARY outcome
Timeframe: Baseline, Day 1 through Day 14The amount of burning on the left and right cheek of each panelist. The scale used to evaluate burning is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Outcome measures
| Measure |
Duac
n=25 Participants
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
|
Epiduo
n=27 Participants
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
|
|---|---|---|
|
Self Assessment of Burning
Baseline
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Self Assessment of Burning
Day 1
|
0.04 units on a scale
Standard Deviation 0.20
|
0.04 units on a scale
Standard Deviation 0.19
|
|
Self Assessment of Burning
Day 2
|
0.04 units on a scale
Standard Deviation 0.20
|
0.04 units on a scale
Standard Deviation 0.19
|
|
Self Assessment of Burning
Day 3
|
0.12 units on a scale
Standard Deviation 0.33
|
0.15 units on a scale
Standard Deviation 0.36
|
|
Self Assessment of Burning
Day 6
|
0.12 units on a scale
Standard Deviation 0.33
|
0.56 units on a scale
Standard Deviation 0.85
|
|
Self Assessment of Burning
Day 7
|
0.17 units on a scale
Standard Deviation 0.48
|
0.70 units on a scale
Standard Deviation 0.87
|
|
Self Assessment of Burning
Day 8
|
0.17 units on a scale
Standard Deviation 0.48
|
0.50 units on a scale
Standard Deviation 0.81
|
|
Self Assessment of Burning
Day 9
|
0.13 units on a scale
Standard Deviation 0.45
|
0.27 units on a scale
Standard Deviation 0.67
|
|
Self Assessment of Burning
Day 10
|
0.13 units on a scale
Standard Deviation 0.45
|
0.31 units on a scale
Standard Deviation 0.68
|
|
Self Assessment of Burning
Day 13
|
0.08 units on a scale
Standard Deviation 0.28
|
0.35 units on a scale
Standard Deviation 0.75
|
|
Self Assessment of Burning
Day 14
|
0.08 units on a scale
Standard Deviation 0.28
|
0.19 units on a scale
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: Baseline, Day 1 through Day 14The amount of stinging on the left and right cheek of each panelist. The scale used to evaluate stinging is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of stinging were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Outcome measures
| Measure |
Duac
n=25 Participants
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
|
Epiduo
n=27 Participants
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
|
|---|---|---|
|
Self Assessment of Stinging
Day 8
|
0.17 units on a scale
Standard Deviation 0.48
|
0.35 units on a scale
Standard Deviation 0.69
|
|
Self Assessment of Stinging
Baseline
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Self Assessment of Stinging
Day 1
|
0.08 units on a scale
Standard Deviation 0.28
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Self Assessment of Stinging
Day 2
|
0.08 units on a scale
Standard Deviation 0.28
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Self Assessment of Stinging
Day 3
|
0.12 units on a scale
Standard Deviation 0.44
|
0.04 units on a scale
Standard Deviation 0.19
|
|
Self Assessment of Stinging
Day 6
|
0.1 units on a scale
Standard Deviation 0.4
|
0.4 units on a scale
Standard Deviation 0.8
|
|
Self Assessment of Stinging
Day 7
|
0.17 units on a scale
Standard Deviation 0.48
|
0.30 units on a scale
Standard Deviation 0.67
|
|
Self Assessment of Stinging
Day 9
|
0.13 units on a scale
Standard Deviation 0.45
|
0.15 units on a scale
Standard Deviation 0.54
|
|
Self Assessment of Stinging
Day 10
|
0.13 units on a scale
Standard Deviation 0.45
|
0.12 units on a scale
Standard Deviation 0.43
|
|
Self Assessment of Stinging
Day 13
|
0.13 units on a scale
Standard Deviation 0.34
|
0.19 units on a scale
Standard Deviation 0.57
|
|
Self Assessment of Stinging
Day 14
|
0.08 units on a scale
Standard Deviation 0.28
|
0.12 units on a scale
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: Baseline, Day 1 through Day 14The amount of dryness on the left and right cheek of each panelist. The scale used to evaluate dryness is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Outcome measures
| Measure |
Duac
n=25 Participants
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
|
Epiduo
n=27 Participants
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
|
|---|---|---|
|
Self Assessment of Dryness
Baseline
|
0.24 units on a scale
Standard Deviation 0.44
|
0.30 units on a scale
Standard Deviation 0.54
|
|
Self Assessment of Dryness
Day 1
|
0.2 units on a scale
Standard Deviation 0.4
|
0.19 units on a scale
Standard Deviation 0.40
|
|
Self Assessment of Dryness
Day 2
|
0.16 units on a scale
Standard Deviation 0.37
|
0.15 units on a scale
Standard Deviation 0.36
|
|
Self Assessment of Dryness
Day 3
|
0.24 units on a scale
Standard Deviation 0.44
|
0.2 units on a scale
Standard Deviation 0.4
|
|
Self Assessment of Dryness
Day 6
|
0.48 units on a scale
Standard Deviation 0.77
|
0.67 units on a scale
Standard Deviation 0.96
|
|
Self Assessment of Dryness
Day 7
|
0.54 units on a scale
Standard Deviation 0.72
|
0.70 units on a scale
Standard Deviation 0.91
|
|
Self Assessment of Dryness
Day 8
|
0.54 units on a scale
Standard Deviation 0.78
|
0.81 units on a scale
Standard Deviation 1.02
|
|
Self Assessment of Dryness
Day 9
|
0.54 units on a scale
Standard Deviation 0.78
|
0.85 units on a scale
Standard Deviation 1.01
|
|
Self Assessment of Dryness
Day 10
|
0.50 units on a scale
Standard Deviation 0.78
|
0.69 units on a scale
Standard Deviation 0.88
|
|
Self Assessment of Dryness
Day 13
|
0.50 units on a scale
Standard Deviation 0.78
|
0.73 units on a scale
Standard Deviation 0.96
|
|
Self Assessment of Dryness
Day 14
|
0.46 units on a scale
Standard Deviation 0.72
|
0.69 units on a scale
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: Baseline, Day 1 through Day 14The amount of roughness on the left and right cheek of each panelist. The scale used to evaluate roughness is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Outcome measures
| Measure |
Duac
n=25 Participants
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
|
Epiduo
n=27 Participants
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
|
|---|---|---|
|
Self Assessment of Texture (Roughness)
Baseline
|
0.28 units on a scale
Standard Deviation 0.54
|
0.15 units on a scale
Standard Deviation 0.36
|
|
Self Assessment of Texture (Roughness)
Day 1
|
0.20 units on a scale
Standard Deviation 0.50
|
0.07 units on a scale
Standard Deviation 0.27
|
|
Self Assessment of Texture (Roughness)
Day 2
|
0.16 units on a scale
Standard Deviation 0.47
|
0.07 units on a scale
Standard Deviation 0.27
|
|
Self Assessment of Texture (Roughness)
Day 3
|
0.32 units on a scale
Standard Deviation 0.69
|
0.07 units on a scale
Standard Deviation 0.27
|
|
Self Assessment of Texture (Roughness)
Day 6
|
0.28 units on a scale
Standard Deviation 0.68
|
0.33 units on a scale
Standard Deviation 0.78
|
|
Self Assessment of Texture (Roughness)
Day 7
|
0.33 units on a scale
Standard Deviation 0.76
|
0.19 units on a scale
Standard Deviation 0.56
|
|
Self Assessment of Texture (Roughness)
Day 8
|
0.25 units on a scale
Standard Deviation 0.61
|
0.3 units on a scale
Standard Deviation 0.7
|
|
Self Assessment of Texture (Roughness)
Day 9
|
0.29 units on a scale
Standard Deviation 0.69
|
0.15 units on a scale
Standard Deviation 0.46
|
|
Self Assessment of Texture (Roughness)
Day 10
|
0.29 units on a scale
Standard Deviation 0.69
|
0.15 units on a scale
Standard Deviation 0.46
|
|
Self Assessment of Texture (Roughness)
Day 13
|
0.33 units on a scale
Standard Deviation 0.70
|
0.12 units on a scale
Standard Deviation 0.43
|
|
Self Assessment of Texture (Roughness)
Day 14
|
0.29 units on a scale
Standard Deviation 0.69
|
0.15 units on a scale
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: Baseline, Day 1 through Day 14The amount of pain on the left and right cheek of each panelist. The scale used to evaluate pain is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Outcome measures
| Measure |
Duac
n=25 Participants
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
|
Epiduo
n=27 Participants
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
|
|---|---|---|
|
Self Assessment of Pain
Baseline
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Self Assessment of Pain
Day 1
|
0.04 units on a scale
Standard Deviation 0.20
|
0.04 units on a scale
Standard Deviation 0.19
|
|
Self Assessment of Pain
Day 2
|
0.04 units on a scale
Standard Deviation 0.20
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Self Assessment of Pain
Day 3
|
0.04 units on a scale
Standard Deviation 0.20
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Self Assessment of Pain
Day 6
|
0.04 units on a scale
Standard Deviation 0.20
|
0.1 units on a scale
Standard Deviation 0.4
|
|
Self Assessment of Pain
Day 7
|
0.04 units on a scale
Standard Deviation 0.20
|
0.04 units on a scale
Standard Deviation 0.19
|
|
Self Assessment of Pain
Day 8
|
0.04 units on a scale
Standard Deviation 0.20
|
0.04 units on a scale
Standard Deviation 0.20
|
|
Self Assessment of Pain
Day 9
|
0.04 units on a scale
Standard Deviation 0.20
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Self Assessment of Pain
Day 10
|
0.04 units on a scale
Standard Deviation 0.20
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Self Assessment of Pain
Day 13
|
0.04 units on a scale
Standard Deviation 0.20
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Self Assessment of Pain
Day 14
|
0.04 units on a scale
Standard Deviation 0.20
|
0.00 units on a scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Baseline, Day 1 through Day 14The amount of crusting on the left and right cheek of each panelist. The scale used to evaluate crusting is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Outcome measures
| Measure |
Duac
n=25 Participants
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
|
Epiduo
n=27 Participants
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
|
|---|---|---|
|
Self Assessment of Crusting
Baseline
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Self Assessment of Crusting
Day 1
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Self Assessment of Crusting
Day 2
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Self Assessment of Crusting
Day 3
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Self Assessment of Crusting
Day 6
|
0.00 units on a scale
Standard Deviation 0.00
|
0.07 units on a scale
Standard Deviation 0.38
|
|
Self Assessment of Crusting
Day 7
|
0.00 units on a scale
Standard Deviation 0.00
|
0.04 units on a scale
Standard Deviation 0.19
|
|
Self Assessment of Crusting
Day 8
|
0.00 units on a scale
Standard Deviation 0.00
|
0.04 units on a scale
Standard Deviation 0.20
|
|
Self Assessment of Crusting
Day 9
|
0.00 units on a scale
Standard Deviation 0.00
|
0.04 units on a scale
Standard Deviation 0.20
|
|
Self Assessment of Crusting
Day 10
|
0.00 units on a scale
Standard Deviation 0.00
|
0.04 units on a scale
Standard Deviation 0.20
|
|
Self Assessment of Crusting
Day 13
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Self Assessment of Crusting
Day 14
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Baseline, Day 1 through Day 14The amount of blistering on the left and right cheek of each panelist. The scale used to evaluate blistering is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Outcome measures
| Measure |
Duac
n=25 Participants
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
|
Epiduo
n=27 Participants
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
|
|---|---|---|
|
Self Assessment of Blistering
Baseline
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Self Assessment of Blistering
Day 1
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Self Assessment of Blistering
Day 2
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Self Assessment of Blistering
Day 3
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Self Assessment of Blistering
Day 6
|
0.00 units on a scale
Standard Deviation 0.00
|
0.07 units on a scale
Standard Deviation 0.38
|
|
Self Assessment of Blistering
Day 7
|
0.00 units on a scale
Standard Deviation 0.00
|
0.04 units on a scale
Standard Deviation 0.19
|
|
Self Assessment of Blistering
Day 8
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Self Assessment of Blistering
Day 9
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Self Assessment of Blistering
Day 10
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Self Assessment of Blistering
Day 13
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Self Assessment of Blistering
Day 14
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Baseline, Day 1 through Day 14The amount of oiliness on the left and right cheek of each panelist. The scale used to evaluate oiliness is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Outcome measures
| Measure |
Duac
n=25 Participants
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
|
Epiduo
n=27 Participants
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
|
|---|---|---|
|
Self Assessment of Oiliness
Day 10
|
0.00 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.2
|
|
Self Assessment of Oiliness
Baseline
|
0.12 units on a scale
Standard Deviation 0.33
|
0.19 units on a scale
Standard Deviation 0.40
|
|
Self Assessment of Oiliness
Day 1
|
0.08 units on a scale
Standard Deviation 0.28
|
0.11 units on a scale
Standard Deviation 0.42
|
|
Self Assessment of Oiliness
Day 2
|
0.00 units on a scale
Standard Deviation 0.00
|
0.04 units on a scale
Standard Deviation 0.19
|
|
Self Assessment of Oiliness
Day 3
|
0.08 units on a scale
Standard Deviation 0.28
|
0.11 units on a scale
Standard Deviation 0.42
|
|
Self Assessment of Oiliness
Day 6
|
0.04 units on a scale
Standard Deviation 0.20
|
0.04 units on a scale
Standard Deviation 0.19
|
|
Self Assessment of Oiliness
Day 7
|
0.00 units on a scale
Standard Deviation 0.00
|
0.07 units on a scale
Standard Deviation 0.27
|
|
Self Assessment of Oiliness
Day 8
|
0.00 units on a scale
Standard Deviation 0.00
|
0.04 units on a scale
Standard Deviation 0.20
|
|
Self Assessment of Oiliness
Day 9
|
0.00 units on a scale
Standard Deviation 0.00
|
0.08 units on a scale
Standard Deviation 0.27
|
|
Self Assessment of Oiliness
Day 13
|
0.00 units on a scale
Standard Deviation 0.00
|
0.12 units on a scale
Standard Deviation 0.43
|
|
Self Assessment of Oiliness
Day 14
|
0.00 units on a scale
Standard Deviation 0.00
|
0.08 units on a scale
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: Day 14The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How do you rate the comfort of the skin where you are currently treating with the study product? The subject replied using the following scale: 1. \- Very Comfortable 2. \- Comfortable 3. \- Somewhat Comfortable 4. \- Somewhat Uncomfortable 5. \- Uncomfortable
Outcome measures
| Measure |
Duac
n=25 Participants
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
|
Epiduo
n=27 Participants
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - How do You Rate the Comfort of the Skin Where You Are Currently Treating With the Study Product?
|
2.38 units on a scale
Standard Deviation 1.13
|
2.23 units on a scale
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: Day 14The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How compliant were you with applying the study product each and every day? The subject replied using the following scale: 0 - Not Compliant at all (\<50%) 1. \- Mostly Compliant (50%-79%) 2. \- Very Compliant (80%-100%)
Outcome measures
| Measure |
Duac
n=25 Participants
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
|
Epiduo
n=27 Participants
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - How Compliant Were You With Applying the Study Product Each and Every Day?
|
2.00 units on a scale
Standard Deviation 0.00
|
2.00 units on a scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Day 14The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product? The subject replied using the following scale: 1 - Yes 0 - No
Outcome measures
| Measure |
Duac
n=25 Participants
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
|
Epiduo
n=27 Participants
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Did You Feel That Your Skin Was Hydrated and Moisturized While You Were on Your Study Product?
|
0.58 units on a scale
Standard Deviation 0.50
|
0.54 units on a scale
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: Day 14The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up? The subject replied using the following scale: 0 - Not Applicable 1. \- Very Easy 2. \- Easy 3. \- Neutral 4. \- Difficult 5. \- Very Difficult
Outcome measures
| Measure |
Duac
n=25 Participants
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
|
Epiduo
n=27 Participants
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Was the Study Product Easy to Use With Make-up?
|
1.04 units on a scale
Standard Deviation 1.12
|
1.46 units on a scale
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: Day 14The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: What was your overall satisfaction of the study product? The subject replied using the following scale: 1. \- Very Satisfied 2. \- Satisfied 3. \- Neutral 4. \- Unsatisfied 5. \- Very Unsatisfied
Outcome measures
| Measure |
Duac
n=25 Participants
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
|
Epiduo
n=27 Participants
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - What Was Your Overall Satisfaction of the Study Product?
|
2.29 units on a scale
Standard Deviation 1.04
|
2.46 units on a scale
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: Day 14The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up? The subject replied using the following scale: 0 - Not Applicable 1. \- Very Easy 2. \- Easy 3. \- Neutral 4. \- Difficult 5. \- Very Difficult
Outcome measures
| Measure |
Duac
n=25 Participants
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
|
Epiduo
n=27 Participants
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - How do You Rate the Ease of Application of the Study Product?
|
1.17 units on a scale
Standard Deviation 0.38
|
1.00 units on a scale
Standard Deviation 0.00
|
Adverse Events
Duac
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Epiduo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Duac
n=25 participants at risk
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
|
Epiduo
n=27 participants at risk
Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
|
|---|---|---|
|
Nervous system disorders
Headache
|
16.0%
4/25 • Number of events 4 • 14 days
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
|
18.5%
5/27 • Number of events 5 • 14 days
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
|
|
Skin and subcutaneous tissue disorders
Irritation
|
8.0%
2/25 • Number of events 2 • 14 days
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
|
7.4%
2/27 • Number of events 2 • 14 days
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/25 • 14 days
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
|
7.4%
2/27 • Number of events 2 • 14 days
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
|
|
Psychiatric disorders
Insomnia
|
12.0%
3/25 • Number of events 3 • 14 days
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
|
0.00%
0/27 • 14 days
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
2/25 • Number of events 2 • 14 days
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
|
0.00%
0/27 • 14 days
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
|
|
Infections and infestations
Seaonal allergies
|
4.0%
1/25 • Number of events 1 • 14 days
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
|
0.00%
0/27 • 14 days
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
|
|
Musculoskeletal and connective tissue disorders
Menstrual cramps
|
12.0%
3/25 • Number of events 3 • 14 days
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
|
7.4%
2/27 • Number of events 2 • 14 days
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
|
|
General disorders
Toothache
|
8.0%
2/25 • Number of events 2 • 14 days
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
|
3.7%
1/27 • Number of events 1 • 14 days
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
|
|
General disorders
Sore throat
|
8.0%
2/25 • Number of events 2 • 14 days
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
|
11.1%
3/27 • Number of events 3 • 14 days
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
|
|
Infections and infestations
Earache
|
0.00%
0/25 • 14 days
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
|
11.1%
3/27 • Number of events 3 • 14 days
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
|
|
Injury, poisoning and procedural complications
Stitches contusion
|
0.00%
0/25 • 14 days
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
|
3.7%
1/27 • Number of events 1 • 14 days
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
|
|
Injury, poisoning and procedural complications
Scratched cornea
|
0.00%
0/25 • 14 days
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
|
3.7%
1/27 • Number of events 1 • 14 days
Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place