Trial Outcomes & Findings for Compare the Tolerance of Clindamycin 1% /Benzoyl Peroxide (BPO) 5% Gel to Clindamycin 1.2%/ BPO 2.5% Topical Medications (NCT NCT01015638)
NCT ID: NCT01015638
Last Updated: 2017-03-31
Results Overview
Compare tolerability of clindamycin and benzoyl peroxide (BPO) 5% and clindamycin phosphate and benzoyl peroxide 2.5% using visual assessments by an independent blinded grader. Erythema (redness) was evaluated using the following scale: Erythema Grade Description 0 = None 2 = Mild erythema 4 = Moderate confluent erythema 6 = Marked erythema with some edema 8 = Marked erythema, edema, possible erosion
COMPLETED
PHASE4
36 participants
14 days
2017-03-31
Participant Flow
Clinical research center. Enrollment started: 11 Aug 2009 Last patient last visit: 1 Sep 2009
Subjects who met inclusion and exclusion criteria and are willing to participate in the study were required to undergo a 3-day screening period where they will stop the use of all facial products on their face. Subjects were required to use soap free cleanser for washing their face and may apply their normal makeup.
Participant milestones
| Measure |
Clindamycin and BPO 5% Gel
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
|
Clindamycin Phosphate and BPO 2.5% Gel
Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
19
|
|
Overall Study
COMPLETED
|
16
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Clindamycin and BPO 5% Gel
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
|
Clindamycin Phosphate and BPO 2.5% Gel
Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Compare the Tolerance of Clindamycin 1% /Benzoyl Peroxide (BPO) 5% Gel to Clindamycin 1.2%/ BPO 2.5% Topical Medications
Baseline characteristics by cohort
| Measure |
Clindamycin and BPO 5% Gel
n=17 Participants
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
|
Clindamycin Phosphate and BPO 2.5% Gel
n=19 Participants
Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 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
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
19 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: ITT
Compare tolerability of clindamycin and benzoyl peroxide (BPO) 5% and clindamycin phosphate and benzoyl peroxide 2.5% using visual assessments by an independent blinded grader. Erythema (redness) was evaluated using the following scale: Erythema 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 |
Clindamycin and BPO 5% Gel
n=17 Participants
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
|
Clindamycin Phosphate and BPO 2.5% Gel
n=19 Participants
Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
|
|---|---|---|
|
Erythema (Redness)
Day 10
|
1.78 units on a scale
Standard Deviation 1.26
|
1.72 units on a scale
Standard Deviation 1.18
|
|
Erythema (Redness)
Day 0
|
0.94 units on a scale
Standard Deviation 0.83
|
1.05 units on a scale
Standard Deviation 0.78
|
|
Erythema (Redness)
Day 1
|
1.42 units on a scale
Standard Deviation 1.32
|
1.24 units on a scale
Standard Deviation .70
|
|
Erythema (Redness)
Day 2
|
1.45 units on a scale
Standard Deviation 1.18
|
1.49 units on a scale
Standard Deviation 1.33
|
|
Erythema (Redness)
Day 3
|
1.27 units on a scale
Standard Deviation .96
|
1.36 units on a scale
Standard Deviation 1.14
|
|
Erythema (Redness)
Day 6
|
1.55 units on a scale
Standard Deviation 1.15
|
1.87 units on a scale
Standard Deviation 1.23
|
|
Erythema (Redness)
Day 7
|
1.72 units on a scale
Standard Deviation 1.14
|
1.88 units on a scale
Standard Deviation 1.25
|
|
Erythema (Redness)
Day 8
|
1.39 units on a scale
Standard Deviation .86
|
1.70 units on a scale
Standard Deviation 1.38
|
|
Erythema (Redness)
Day 9
|
1.38 units on a scale
Standard Deviation 1.00
|
1.82 units on a scale
Standard Deviation 1.38
|
|
Erythema (Redness)
Day 13
|
1.34 units on a scale
Standard Deviation 1.03
|
1.82 units on a scale
Standard Deviation 1.44
|
|
Erythema (Redness)
Day 14
|
1.51 units on a scale
Standard Deviation 1.06
|
1.82 units on a scale
Standard Deviation 1.18
|
PRIMARY outcome
Timeframe: 14 daysPopulation: ITT
Visual Dryness was evaluated using the following scale: Grade 0 = None 2 = Slight flaking 4 = Moderate flaking/scaling 6 = Marked scaling / slight fissuring 8 Severe scaling, fissuring
Outcome measures
| Measure |
Clindamycin and BPO 5% Gel
n=17 Participants
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
|
Clindamycin Phosphate and BPO 2.5% Gel
n=19 Participants
Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
|
|---|---|---|
|
Skin Dryness
Day 0
|
0.06 units on a scale
Standard Deviation 0.24
|
0.05 units on a scale
Standard Deviation 0.23
|
|
Skin Dryness
Day 1
|
0.05 units on a scale
Standard Deviation 0.05
|
0.15 units on a scale
Standard Deviation 0.30
|
|
Skin Dryness
Day 2
|
0.05 units on a scale
Standard Deviation 0.05
|
0.37 units on a scale
Standard Deviation 0.66
|
|
Skin Dryness
Day 3
|
0.27 units on a scale
Standard Deviation 0.55
|
0.22 units on a scale
Standard Deviation 0.37
|
|
Skin Dryness
Day 6
|
0.29 units on a scale
Standard Deviation 0.55
|
0.24 units on a scale
Standard Deviation 0.53
|
|
Skin Dryness
Day 7
|
0.32 units on a scale
Standard Deviation 0.54
|
0.15 units on a scale
Standard Deviation 0.45
|
|
Skin Dryness
Day 8
|
0.40 units on a scale
Standard Deviation 0.59
|
0.15 units on a scale
Standard Deviation 0.32
|
|
Skin Dryness
Day 9
|
0.35 units on a scale
Standard Deviation 0.56
|
0.15 units on a scale
Standard Deviation 0.30
|
|
Skin Dryness
Day 10
|
0.47 units on a scale
Standard Deviation 1.04
|
0.36 units on a scale
Standard Deviation 0.99
|
|
Skin Dryness
Day 13
|
0.76 units on a scale
Standard Deviation 1.33
|
0.28 units on a scale
Standard Deviation 0.46
|
|
Skin Dryness
Day 14
|
0.62 units on a scale
Standard Deviation 1.05
|
0.31 units on a scale
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: 14 daysTo assess skin moisture and hydration using transepidermal water loss (TEWL). Results are measured on a continuous scale as grams per meters squared (m\^2) per hour. 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.
Outcome measures
| Measure |
Clindamycin and BPO 5% Gel
n=17 Participants
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
|
Clindamycin Phosphate and BPO 2.5% Gel
n=19 Participants
Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
|
|---|---|---|
|
Skin Moisture and Hydration
Day 0
|
10.82 grams/m^2/hour
Standard Deviation 4.15
|
9.71 grams/m^2/hour
Standard Deviation 3.14
|
|
Skin Moisture and Hydration
Day 3
|
11.98 grams/m^2/hour
Standard Deviation 4.18
|
10.84 grams/m^2/hour
Standard Deviation 3.46
|
|
Skin Moisture and Hydration
Day 7
|
13.01 grams/m^2/hour
Standard Deviation 3.16
|
11.36 grams/m^2/hour
Standard Deviation 2.91
|
|
Skin Moisture and Hydration
Day 14
|
13.94 grams/m^2/hour
Standard Deviation 4.10
|
13.59 grams/m^2/hour
Standard Deviation 4.68
|
SECONDARY outcome
Timeframe: 14 daysPopulation: ITT
The 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 |
Clindamycin and BPO 5% Gel
n=17 Participants
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
|
Clindamycin Phosphate and BPO 2.5% Gel
n=19 Participants
Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
|
|---|---|---|
|
Changes in the Skin Surface Hydration
Day 0
|
546.40 microsiemens
Standard Deviation 185.75
|
478.02 microsiemens
Standard Deviation 170.88
|
|
Changes in the Skin Surface Hydration
4 Hours Post 1st Treatment
|
554.00 microsiemens
Standard Deviation 202.94
|
430.78 microsiemens
Standard Deviation 158.98
|
|
Changes in the Skin Surface Hydration
Day 3
|
572.39 microsiemens
Standard Deviation 200.31
|
529.96 microsiemens
Standard Deviation 124.88
|
|
Changes in the Skin Surface Hydration
Day 7
|
484.94 microsiemens
Standard Deviation 212.56
|
413.51 microsiemens
Standard Deviation 131.31
|
|
Changes in the Skin Surface Hydration
Day 14
|
361.59 microsiemens
Standard Deviation 177.01
|
354.46 microsiemens
Standard Deviation 144.06
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: ITT
At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, pain, and dryness in this questionnaire. Each symptom was rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe. The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of burning are presented here.
Outcome measures
| Measure |
Clindamycin and BPO 5% Gel
n=17 Participants
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
|
Clindamycin Phosphate and BPO 2.5% Gel
n=19 Participants
Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
|
|---|---|---|
|
Subject Tolerability - Burning
Day 2
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Tolerability - Burning
Day 0
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Tolerability - Burning
Day 1
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Tolerability - Burning
Day 3
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Tolerability - Burning
Day 6
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Tolerability - Burning
Day 7
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Tolerability - Burning
Day 8
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Tolerability - Burning
Day 9
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Tolerability - Burning
Day 10
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Tolerability - Burning
Day 13
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Tolerability - Burning
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: 2 weeksAt each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None,1 - Slight,2 - Moderate, or 3 - Severe. The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of stinging are presented here.
Outcome measures
| Measure |
Clindamycin and BPO 5% Gel
n=17 Participants
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
|
Clindamycin Phosphate and BPO 2.5% Gel
n=19 Participants
Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
|
|---|---|---|
|
Subject Tolerability - Stinging
Day 0
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Tolerability - Stinging
Day 1
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Tolerability - Stinging
Day 2
|
0.06 units on a scale
Standard Deviation 0.24
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Tolerability - Stinging
Day 3
|
0.00 units on a scale
Standard Deviation 0.00
|
0.05 units on a scale
Standard Deviation 0.23
|
|
Subject Tolerability - Stinging
Day 6
|
0.00 units on a scale
Standard Deviation 0.00
|
0.05 units on a scale
Standard Deviation 0.23
|
|
Subject Tolerability - Stinging
Day 7
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Tolerability - Stinging
Day 8
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Tolerability - Stinging
Day 9
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Tolerability - Stinging
Day 10
|
0.00 units on a scale
Standard Deviation 0.00
|
0.05 units on a scale
Standard Deviation 0.23
|
|
Subject Tolerability - Stinging
Day 13
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Tolerability - Stinging
Day 14
|
0.00 units on a scale
Standard Deviation 0.00
|
0.11 units on a scale
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: 2 weeksAt each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe. The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of dryness are presented here.
Outcome measures
| Measure |
Clindamycin and BPO 5% Gel
n=17 Participants
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
|
Clindamycin Phosphate and BPO 2.5% Gel
n=19 Participants
Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
|
|---|---|---|
|
Subject Assessment - Dryness
Day 0
|
0.00 units on a scale
Standard Deviation 0.00
|
0.26 units on a scale
Standard Deviation 0.56
|
|
Subject Assessment - Dryness
Day 1
|
0.00 units on a scale
Standard Deviation 0.00
|
0.26 units on a scale
Standard Deviation 0.56
|
|
Subject Assessment - Dryness
Day 2
|
0.00 units on a scale
Standard Deviation 0.00
|
0.21 units on a scale
Standard Deviation 0.54
|
|
Subject Assessment - Dryness
Day 3
|
0.00 units on a scale
Standard Deviation 0.00
|
0.11 units on a scale
Standard Deviation 0.46
|
|
Subject Assessment - Dryness
Day 6
|
0.06 units on a scale
Standard Deviation 0.24
|
0.11 units on a scale
Standard Deviation 0.32
|
|
Subject Assessment - Dryness
Day 7
|
0.12 units on a scale
Standard Deviation 0.49
|
0.21 units on a scale
Standard Deviation 0.54
|
|
Subject Assessment - Dryness
Day 8
|
0.12 units on a scale
Standard Deviation 0.49
|
0.16 units on a scale
Standard Deviation 0.50
|
|
Subject Assessment - Dryness
Day 9
|
0.2 units on a scale
Standard Deviation 0.5
|
0.16 units on a scale
Standard Deviation 0.50
|
|
Subject Assessment - Dryness
Day 10
|
0.24 units on a scale
Standard Deviation 0.56
|
0.16 units on a scale
Standard Deviation 0.50
|
|
Subject Assessment - Dryness
Day 13
|
0.35 units on a scale
Standard Deviation 0.70
|
0.16 units on a scale
Standard Deviation 0.50
|
|
Subject Assessment - Dryness
Day 14
|
0.24 units on a scale
Standard Deviation 0.56
|
0.21 units on a scale
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: 2 weeksAt each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, roughness, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe. The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of roughness are presented here.
Outcome measures
| Measure |
Clindamycin and BPO 5% Gel
n=17 Participants
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
|
Clindamycin Phosphate and BPO 2.5% Gel
n=19 Participants
Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
|
|---|---|---|
|
Subject Assessment - Roughness
Day 1
|
0.00 units on a scale
Standard Deviation 0.00
|
0.05 units on a scale
Standard Deviation 0.23
|
|
Subject Assessment - Roughness
Day 0
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Roughness
Day 2
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Roughness
Day 3
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Roughness
Day 6
|
0.06 units on a scale
Standard Deviation 0.24
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Roughness
Day 7
|
0.06 units on a scale
Standard Deviation 0.24
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Roughness
Day 8
|
0.06 units on a scale
Standard Deviation 0.24
|
0.05 units on a scale
Standard Deviation 0.23
|
|
Subject Assessment - Roughness
Day 9
|
0.18 units on a scale
Standard Deviation 0.53
|
0.05 units on a scale
Standard Deviation 0.23
|
|
Subject Assessment - Roughness
Day 10
|
0.12 units on a scale
Standard Deviation 0.49
|
0.05 units on a scale
Standard Deviation 0.23
|
|
Subject Assessment - Roughness
Day 13
|
0.00 units on a scale
Standard Deviation 0.00
|
0.05 units on a scale
Standard Deviation 0.23
|
|
Subject Assessment - Roughness
Day 14
|
0.00 units on a scale
Standard Deviation 0.00
|
0.05 units on a scale
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: 2 WeeksAt each visit, panelists were supplied a self-assessment questionnaire, which included assessment of pain. Subjects were asked to evaluate burning, stinging, pain, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe. The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of pain are presented here.
Outcome measures
| Measure |
Clindamycin and BPO 5% Gel
n=17 Participants
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
|
Clindamycin Phosphate and BPO 2.5% Gel
n=19 Participants
Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
|
|---|---|---|
|
Subject Assessment - Pain
Day 0
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Pain
Day 1
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Pain
Day 2
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Pain
Day 3
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Pain
Day 6
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Pain
Day 7
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Pain
Day 8
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Pain
Day 9
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Pain
Day 10
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Pain
Day 13
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Pain
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: 2 WeeksAt each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate crusting, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe. The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of crusting are presented here.
Outcome measures
| Measure |
Clindamycin and BPO 5% Gel
n=17 Participants
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
|
Clindamycin Phosphate and BPO 2.5% Gel
n=19 Participants
Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
|
|---|---|---|
|
Subject Assessment - Crusting
Day 10
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Crusting
Day 6
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Crusting
Day 7
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Crusting
Day 8
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Crusting
Day 0
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Crusting
Day 1
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Crusting
Day 2
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Crusting
Day 3
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Crusting
Day 9
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Crusting
Day 13
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - 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: 2 WeeksAt each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate blistering, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe. The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of blistering are presented here.
Outcome measures
| Measure |
Clindamycin and BPO 5% Gel
n=17 Participants
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
|
Clindamycin Phosphate and BPO 2.5% Gel
n=19 Participants
Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
|
|---|---|---|
|
Subject Assessment - Blistering
Day 0
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Blistering
Day 1
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Blistering
Day 2
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Blistering
Day 3
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Blistering
Day 6
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Blistering
Day 7
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Blistering
Day 8
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Blistering
Day 9
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Blistering
Day 10
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Blistering
Day 13
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - 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: 2 WeeksAt each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate oiliness, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe. The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of oiliness are presented here.
Outcome measures
| Measure |
Clindamycin and BPO 5% Gel
n=17 Participants
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
|
Clindamycin Phosphate and BPO 2.5% Gel
n=19 Participants
Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
|
|---|---|---|
|
Subject Assessment - Oiliness
Day 0
|
0.18 units on a scale
Standard Deviation 0.53
|
0.16 units on a scale
Standard Deviation 0.37
|
|
Subject Assessment - Oiliness
Day 1
|
0.18 units on a scale
Standard Deviation 0.39
|
0.05 units on a scale
Standard Deviation 0.23
|
|
Subject Assessment - Oiliness
Day 2
|
0.06 units on a scale
Standard Deviation 0.24
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Oiliness
Day 3
|
0.12 units on a scale
Standard Deviation 0.33
|
0.11 units on a scale
Standard Deviation 0.46
|
|
Subject Assessment - Oiliness
Day 6
|
0.06 units on a scale
Standard Deviation 0.24
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Oiliness
Day 7
|
0.06 units on a scale
Standard Deviation 0.24
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Oiliness
Day 8
|
0.06 units on a scale
Standard Deviation 0.24
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Oiliness
Day 9
|
0.06 units on a scale
Standard Deviation 0.24
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Oiliness
Day 10
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Oiliness
Day 13
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
|
Subject Assessment - Oiliness
Day 14
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
Adverse Events
Clindamycin and BPO 5% Gel
Clindamycin Phosphate and BPO 2.5% Gel
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Clindamycin and BPO 5% Gel
n=17 participants at risk
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
|
Clindamycin Phosphate and BPO 2.5% Gel
n=19 participants at risk
Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
|
|---|---|---|
|
Nervous system disorders
Headache
|
11.8%
2/17 • Number of events 2 • 2 weeks
Any study product-related AEs ongoing at the end of the treatment period would be followed until resolved, the condition stabilized, the events are otherwise explained, or the subject was lost to follow-up. In addition, all SAEs would have been followed until resolution as previously stated for study product-related AEs.
|
15.8%
3/19 • Number of events 5 • 2 weeks
Any study product-related AEs ongoing at the end of the treatment period would be followed until resolved, the condition stabilized, the events are otherwise explained, or the subject was lost to follow-up. In addition, all SAEs would have been followed until resolution as previously stated for study product-related AEs.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place