Trial Outcomes & Findings for U0289-402: An Open Label, 8 Week Study to Evaluate the Efficacy and Tolerability of MAXCLARITY II in Subjects With Acne (NCT NCT01706263)
NCT ID: NCT01706263
Last Updated: 2018-01-08
Results Overview
Evaluator assessed the left and right side of the face as inflammatory (papules \[solid elevation of skin with no visible fluid\] and pustules \[small inflamed elevation of the skin that is filled with pus\]) and non-inflammatory (open \[blackheads\] and closed \[whiteheads\] comedones) and total lesions (sum of inflammatory and non-inflammatory lesion) for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 8 was calculated as the value at Week 8 minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value .
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
28 participants
Primary outcome timeframe
Baseline (Day 1) and Week 8
Results posted on
2018-01-08
Participant Flow
Male or female participants aged from 18 to 29 years with mild facial acne vulgaris were enrolled in this study. The study was conducted at three different study centers. Study period was 8 Weeks (56 days) and study conducted from 19 August 2009 to 01 December 2009.
Participant milestones
| Measure |
MAXCLARITY II
The eligible participants applied a small amount of the MAXCLARITY II™ 2.5 percent (%) benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
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|---|---|
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Overall Study
STARTED
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28
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Overall Study
COMPLETED
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28
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
U0289-402: An Open Label, 8 Week Study to Evaluate the Efficacy and Tolerability of MAXCLARITY II in Subjects With Acne
Baseline characteristics by cohort
| Measure |
MAXCLARITY II
n=28 Participants
The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
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Age, Continuous
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21.7 Years
STANDARD_DEVIATION 4.8 • n=5 Participants
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Sex: Female, Male
Female
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18 Participants
n=5 Participants
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Sex: Female, Male
Male
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10 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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7 Participants
n=5 Participants
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Race (NIH/OMB)
White
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20 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 8Population: Intent-to-treat analysis set was used which included data from all randomized participants who received study product.
Evaluator assessed the left and right side of the face as inflammatory (papules \[solid elevation of skin with no visible fluid\] and pustules \[small inflamed elevation of the skin that is filled with pus\]) and non-inflammatory (open \[blackheads\] and closed \[whiteheads\] comedones) and total lesions (sum of inflammatory and non-inflammatory lesion) for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 8 was calculated as the value at Week 8 minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value .
Outcome measures
| Measure |
MAXCLARITY II
n=28 Participants
The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
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Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Week 8
Inflammatory lesion count
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-62.1 Percent change
Standard Deviation 37.1
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Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Week 8
Non-Inflammatory lesion count
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-49.8 Percent change
Standard Deviation 39.7
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Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Week 8
Total lesion count
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-56.9 Percent change
Standard Deviation 32.7
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SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 1, 2, 4Population: Intent-to-treat analysis set.
Evaluator assessed the left side and right side of the face as inflammatory (papules \[solid elevation of skin with no visible fluid\] and pustules \[small inflamed elevation of the skin that is filled with pus\]) and non-inflammatory (open comedones \[blackheads\] and closed comedones \[whiteheads\]) and total lesions for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts was calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to specified time (Weeks 1, 2, and 4) point was calculated as the value at specified time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value .
Outcome measures
| Measure |
MAXCLARITY II
n=28 Participants
The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
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Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Weeks 1, 2, and 4
Inflammatory lesion count, Week 1
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-27.9 Percent change
Standard Deviation 29.8
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Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Weeks 1, 2, and 4
Inflammatory lesion count, Week 4
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-49.5 Percent change
Standard Deviation 30.6
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Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Weeks 1, 2, and 4
Non-Inflammatory lesion count, Week 1
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-9.9 Percent change
Standard Deviation 45.1
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Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Weeks 1, 2, and 4
Non-Inflammatory lesion count, Week 2
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-23.4 Percent change
Standard Deviation 38.0
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Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Weeks 1, 2, and 4
Non-Inflammatory lesion count, Week 4
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-34.3 Percent change
Standard Deviation 37.5
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Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Weeks 1, 2, and 4
Total lesion count, Week 1
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-22.6 Percent change
Standard Deviation 27.6
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Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Weeks 1, 2, and 4
Total lesion count, Week 2
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-37.8 Percent change
Standard Deviation 24.1
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Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Weeks 1, 2, and 4
Total lesion count, Week 4
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-44.9 Percent change
Standard Deviation 28.5
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Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Weeks 1, 2, and 4
Inflammatory lesion count, Week 2
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-50.8 Percent change
Standard Deviation 25.6
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SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 1, 2, 4, 8Population: Intent-to-treat analysis set.
Evaluator assessed the acne severity of participants' faces using the ISGA scale on a five point scale which ranged from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value .
Outcome measures
| Measure |
MAXCLARITY II
n=28 Participants
The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
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Mean Change in Investigator's Static Global Assessment (ISGA) From Baseline to Weeks 1, 2, 4 and 8
ISGA score, Week 1
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-0.07 Score on a scale
Standard Deviation 0.54
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Mean Change in Investigator's Static Global Assessment (ISGA) From Baseline to Weeks 1, 2, 4 and 8
ISGA score, Week 8
|
-0.61 Score on a scale
Standard Deviation 0.69
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Mean Change in Investigator's Static Global Assessment (ISGA) From Baseline to Weeks 1, 2, 4 and 8
ISGA score, Week 2
|
-0.46 Score on a scale
Standard Deviation 0.58
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Mean Change in Investigator's Static Global Assessment (ISGA) From Baseline to Weeks 1, 2, 4 and 8
ISGA score, Week 4
|
-0.39 Score on a scale
Standard Deviation 0.69
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SECONDARY outcome
Timeframe: Up to Week 8Population: Intent-to-treat analysis set.
Evaluator assessed the acne severity of participants' faces using the ISGA scale on a five point scale which ranged from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Percent change from Baseline to specified time point was calculated as the value at specified time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value .
Outcome measures
| Measure |
MAXCLARITY II
n=28 Participants
The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
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Percentage of Participants Who Improved by at Least One Grade on the ISGA
Atleast one grade improvement,Week 1
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17.9 Percentage of participants
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Percentage of Participants Who Improved by at Least One Grade on the ISGA
Atleast two grade improvement,Week 1
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0.0 Percentage of participants
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Percentage of Participants Who Improved by at Least One Grade on the ISGA
Atleast one grade improvement,Week 2
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42.9 Percentage of participants
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Percentage of Participants Who Improved by at Least One Grade on the ISGA
Atleast two grade improvement,Week 2
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3.6 Percentage of participants
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Percentage of Participants Who Improved by at Least One Grade on the ISGA
Atleast one grade improvement,Week 4
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35.7 Percentage of participants
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Percentage of Participants Who Improved by at Least One Grade on the ISGA
Atleast two grade improvement,Week 4
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7.1 Percentage of participants
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Percentage of Participants Who Improved by at Least One Grade on the ISGA
Atleast one grade improvement,Week 8
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50.0 Percentage of participants
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Percentage of Participants Who Improved by at Least One Grade on the ISGA
Atleast two grade improvement,Week 8
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10.7 Percentage of participants
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SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 1, 2, 4, 8Population: Intent-to-treat analysis set.
Erythema , dryness, and peeling, were evaluated independently by the investigator on a five point scale ranged from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value .
Outcome measures
| Measure |
MAXCLARITY II
n=28 Participants
The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
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Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
Erythema, Week 4
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-0.04 Score on scale
Standard Deviation 0.79
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Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
Erythema, Week 8
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-0.32 Score on scale
Standard Deviation 0.55
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Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
Dryness, Week 2
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0.32 Score on scale
Standard Deviation 0.61
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Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
Dryness, Week 4
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0.11 Score on scale
Standard Deviation 0.42
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Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
Dryness, Week 8
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0.11 Score on scale
Standard Deviation 0.31
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Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
Peeling, Week 1
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0.11 Score on scale
Standard Deviation 0.42
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Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
Peeling, Week 8
|
0.11 Score on scale
Standard Deviation 0.31
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Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
Erythema, Week 1
|
0.00 Score on scale
Standard Deviation 0.38
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Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
Erythema, Week 2
|
-0.04 Score on scale
Standard Deviation 0.43
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Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
Dryness, Week 1
|
0.14 Score on scale
Standard Deviation 0.45
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Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
Peeling, Week 2
|
0.21 Score on scale
Standard Deviation 0.50
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Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
Peeling, Week 4
|
0.04 Score on scale
Standard Deviation 0.19
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SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 1, 2, 4, 8Population: Intent-to-treat analysis set.
Redness, dryness, burning, itching and scaling were evaluated independently by the participant on a five point scale ranged from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value .
Outcome measures
| Measure |
MAXCLARITY II
n=28 Participants
The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
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Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8
Redness,Week 1
|
-0.39 Score on scale
Standard Deviation 1.03
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Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8
Redness,Week 2
|
-0.25 Score on scale
Standard Deviation 1.24
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Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8
Redness,Week 4
|
-0.18 Score on scale
Standard Deviation 1.09
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Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8
Redness,Week 8
|
-0.36 Score on scale
Standard Deviation 1.34
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Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8
Dryness,Week 1
|
0.04 Score on scale
Standard Deviation 1.20
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Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8
Dryness,Week 2
|
0.07 Score on scale
Standard Deviation 1.30
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Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8
Burning,Week 2
|
0.36 Score on scale
Standard Deviation 1.22
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Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8
Burning,Week 4
|
0.32 Score on scale
Standard Deviation 0.67
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Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8
Burning,Week 8
|
-0.07 Score on scale
Standard Deviation 1.02
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Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8
Itching,Week 1
|
0.07 Score on scale
Standard Deviation 0.90
|
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Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8
Itching,Week 2
|
0.07 Score on scale
Standard Deviation 1.02
|
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Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8
Itching,Week 4
|
0.14 Score on scale
Standard Deviation 1.15
|
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Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8
Itching,Week 8
|
0.07 Score on scale
Standard Deviation 0.94
|
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Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8
Scaling,Week 1
|
-0.14 Score on scale
Standard Deviation 0.71
|
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Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8
Scaling,Week 2
|
-0.11 Score on scale
Standard Deviation 1.13
|
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Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8
Scaling,Week 4
|
-0.04 Score on scale
Standard Deviation 0.74
|
|
Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8
Scaling,Week 8
|
-0.18 Score on scale
Standard Deviation 1.12
|
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Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8
Dryness,Week 4
|
0.00 Score on scale
Standard Deviation 1.09
|
|
Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8
Dryness,Week 8
|
0.11 Score on scale
Standard Deviation 1.40
|
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Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8
Burning,Week 1
|
0.21 Score on scale
Standard Deviation 1.10
|
Adverse Events
MAXCLARITY II
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MAXCLARITY II
n=28 participants at risk
The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
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|---|---|
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Gastrointestinal disorders
Hiatus hernia
|
3.6%
1/28 • Adverse events and serious adverse events were reported throughout the study (from Baseline Up to Week 8)
Intent-to-treat analysis set was used to report adverse events.
|
|
General disorders
Application Site Burning
|
3.6%
1/28 • Adverse events and serious adverse events were reported throughout the study (from Baseline Up to Week 8)
Intent-to-treat analysis set was used to report adverse events.
|
|
Infections and infestations
Bronchitis
|
7.1%
2/28 • Adverse events and serious adverse events were reported throughout the study (from Baseline Up to Week 8)
Intent-to-treat analysis set was used to report adverse events.
|
|
Infections and infestations
Influenza
|
10.7%
3/28 • Adverse events and serious adverse events were reported throughout the study (from Baseline Up to Week 8)
Intent-to-treat analysis set was used to report adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
17.9%
5/28 • Adverse events and serious adverse events were reported throughout the study (from Baseline Up to Week 8)
Intent-to-treat analysis set was used to report adverse events.
|
|
Infections and infestations
Pneumonia
|
3.6%
1/28 • Adverse events and serious adverse events were reported throughout the study (from Baseline Up to Week 8)
Intent-to-treat analysis set was used to report adverse events.
|
|
Infections and infestations
Sinusitis
|
3.6%
1/28 • Adverse events and serious adverse events were reported throughout the study (from Baseline Up to Week 8)
Intent-to-treat analysis set was used to report adverse events.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
3.6%
1/28 • Adverse events and serious adverse events were reported throughout the study (from Baseline Up to Week 8)
Intent-to-treat analysis set was used to report adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
1/28 • Adverse events and serious adverse events were reported throughout the study (from Baseline Up to Week 8)
Intent-to-treat analysis set was used to report adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
3.6%
1/28 • Adverse events and serious adverse events were reported throughout the study (from Baseline Up to Week 8)
Intent-to-treat analysis set was used to report adverse events.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
3.6%
1/28 • Adverse events and serious adverse events were reported throughout the study (from Baseline Up to Week 8)
Intent-to-treat analysis set was used to report adverse events.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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