Trial Outcomes & Findings for 8 Week Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITY II and MURAD To Treat Acne (NCT NCT02524665)
NCT ID: NCT02524665
Last Updated: 2017-04-13
Results Overview
During each study visit, expert grader (blinded 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 \[blackheads\] and closed \[whiteheads\] comedones) 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 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 is defined as value at Day 1.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
Baseline and Week 8
Results posted on
2017-04-13
Participant Flow
From September-2009 to December-2009, total 20 participants were randomized at one of center in Louisville. MAXCLARITY II™ is a trademark of Stiefel Laboratories, Inc and MURAD™ is licensed product of Murad Europe Limited.
Male or female participants 18 to 29 years of age with mild facial acne vulgaris, characterized by at least 24 facial inflammatory lesions (papules and pustules) and/or non-inflammatory lesions (open and closed comedones) on each half of the face (excluding nose and front hairline areas) were included.
Participant milestones
| Measure |
MAXCLARITY II + Murad
MaxClarity II was a 2.5 percent (%) benzoyl peroxide (BPO) foam cleanser and foam treatment, 0.5% salicylic acid (SA) toner foam. Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. Both treatments were applied topically to 1 side of face twice daily (BD) for 8 weeks. MaxClarity II application: Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in ante meridiem (AM) and toner foam in post meridiem (PM). Murad application: In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
MAXCLARITY II + Murad
MaxClarity II was a 2.5 percent (%) benzoyl peroxide (BPO) foam cleanser and foam treatment, 0.5% salicylic acid (SA) toner foam. Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. Both treatments were applied topically to 1 side of face twice daily (BD) for 8 weeks. MaxClarity II application: Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in ante meridiem (AM) and toner foam in post meridiem (PM). Murad application: In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
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|---|---|
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Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
8 Week Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITY II and MURAD To Treat Acne
Baseline characteristics by cohort
| Measure |
MAXCLARITY II + Murad
n=20 Participants
MAXCLARITY II was a 2.5 percent (%) benzoyl peroxide (BPO) foam cleanser and foam treatment, 0.5% salicylic acid (SA) toner foam. Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. Both treatments were applied topically to 1 side of face twice daily (BD) for 8 weeks. MAXCLARITY II application: Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in ante meridiem (AM) and toner foam in post meridiem (PM). Murad application: In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
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|---|---|
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Age, Continuous
|
22.5 Years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8Population: Intent-to-treat (ITT) analysis set was used which included data from all randomized participants who received study product. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles).
During each study visit, expert grader (blinded 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 \[blackheads\] and closed \[whiteheads\] comedones) 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 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 is defined as value at Day 1.
Outcome measures
| Measure |
MAXCLARITY II
n=20 Participants
MAXCLARITY II was a 2.5% BPO foam cleanser and foam treatment, 0.5% SA toner foam. It was applied topically to 1 side of face BD for 8 weeks. Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in AM and toner foam in PM.
|
Murad
n=20 Participants
Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. It was applied topically to 1 side of face BD for 8 weeks. In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
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|---|---|---|
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Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 8.
Inflammatory lesion counts- Week 8, n=19, 17
|
-78.70 Percent change
Standard Deviation 40.93
|
-61.52 Percent change
Standard Deviation 47.59
|
|
Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 8.
Non-inflammatory lesion counts- Week 8, n=19, 19
|
-69.32 Percent change
Standard Deviation 48.69
|
-77.09 Percent change
Standard Deviation 23.50
|
|
Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 8.
Total lesion counts-Week 8, n=19, 19
|
-76.67 Percent change
Standard Deviation 30.79
|
-75.01 Percent change
Standard Deviation 23.22
|
SECONDARY outcome
Timeframe: Baseline and Week 1, 2, 4Population: ITT analysis set. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles).
During each study visit, expert grader (blinded 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 were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline is defined as value at Day 1.
Outcome measures
| Measure |
MAXCLARITY II
n=20 Participants
MAXCLARITY II was a 2.5% BPO foam cleanser and foam treatment, 0.5% SA toner foam. It was applied topically to 1 side of face BD for 8 weeks. Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in AM and toner foam in PM.
|
Murad
n=20 Participants
Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. It was applied topically to 1 side of face BD for 8 weeks. In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
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|---|---|---|
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Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 1, 2 and 4.
Inflammatory lesion counts- Week 1, n=19, 17
|
-17.69 Percent change
Standard Deviation 38.89
|
-7.85 Percent change
Standard Deviation 83.21
|
|
Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 1, 2 and 4.
Inflammatory lesion counts- Week 2, n=19, 17
|
-46.69 Percent change
Standard Deviation 55.00
|
-14.25 Percent change
Standard Deviation 66.06
|
|
Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 1, 2 and 4.
Inflammatory lesion counts- Week 4, n=19, 17
|
-55.35 Percent change
Standard Deviation 46.13
|
-51.95 Percent change
Standard Deviation 47.60
|
|
Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 1, 2 and 4.
Non-inflammatory lesion counts- Week 1, n=19, 19
|
-4.94 Percent change
Standard Deviation 52.60
|
-15.92 Percent change
Standard Deviation 28.91
|
|
Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 1, 2 and 4.
Non-inflammatory lesion counts- Week 2, n=19, 19
|
-28.07 Percent change
Standard Deviation 48.27
|
-37.07 Percent change
Standard Deviation 28.42
|
|
Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 1, 2 and 4.
Non-inflammatory lesion counts- Week 4, n=19, 19
|
-52.85 Percent change
Standard Deviation 47.46
|
-60.27 Percent change
Standard Deviation 24.54
|
|
Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 1, 2 and 4.
Total lesion counts-Week 1, n=19, 19
|
-12.57 Percent change
Standard Deviation 27.27
|
-18.29 Percent change
Standard Deviation 23.53
|
|
Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 1, 2 and 4.
Total lesion counts-Week 2, n=19, 19
|
-37.06 Percent change
Standard Deviation 27.97
|
-35.84 Percent change
Standard Deviation 22.91
|
|
Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 1, 2 and 4.
Total lesion counts-Week 4, n=19, 19
|
-60.93 Percent change
Standard Deviation 26.94
|
-60.73 Percent change
Standard Deviation 22.49
|
SECONDARY outcome
Timeframe: Baseline and Week 1, 2, 4, 8Population: ITT analysis set. Only those participants available at the indicated time points were analyzed.
During each study visit, investigators/expert grader evaluated the acne severity of participants' faces using the ISGA scale on right and left side of face on a five point scale from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline. Baseline is defined as value at Day 1.
Outcome measures
| Measure |
MAXCLARITY II
n=19 Participants
MAXCLARITY II was a 2.5% BPO foam cleanser and foam treatment, 0.5% SA toner foam. It was applied topically to 1 side of face BD for 8 weeks. Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in AM and toner foam in PM.
|
Murad
n=19 Participants
Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. It was applied topically to 1 side of face BD for 8 weeks. In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
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|---|---|---|
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Mean Change in Investigator's Static Global Assessment (ISGA) From Baseline to Week 1, 2, 4 and 8
ISGA score-Week 1
|
-0.05 Score on a scale
Standard Deviation 0.40
|
-0.11 Score on a scale
Standard Deviation 0.32
|
|
Mean Change in Investigator's Static Global Assessment (ISGA) From Baseline to Week 1, 2, 4 and 8
ISGA score -Week 2
|
-0.16 Score on a scale
Standard Deviation 0.60
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-0.05 Score on a scale
Standard Deviation 0.40
|
|
Mean Change in Investigator's Static Global Assessment (ISGA) From Baseline to Week 1, 2, 4 and 8
ISGA score -Week 4
|
-0.47 Score on a scale
Standard Deviation 0.70
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-0.58 Score on a scale
Standard Deviation 0.51
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|
Mean Change in Investigator's Static Global Assessment (ISGA) From Baseline to Week 1, 2, 4 and 8
ISGA score -Week 8
|
-1.16 Score on a scale
Standard Deviation 0.90
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-0.89 Score on a scale
Standard Deviation 0.74
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SECONDARY outcome
Timeframe: Baseline and Week 1, 2, 4, 8Population: ITT analysis set. Only those participants with data available at the indicated time points were analyzed.
Erythema (redness), dryness, and peeling, were evaluated independently by the investigator on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline. Baseline is defined as value at Day 1.
Outcome measures
| Measure |
MAXCLARITY II
n=19 Participants
MAXCLARITY II was a 2.5% BPO foam cleanser and foam treatment, 0.5% SA toner foam. It was applied topically to 1 side of face BD for 8 weeks. Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in AM and toner foam in PM.
|
Murad
n=19 Participants
Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. It was applied topically to 1 side of face BD for 8 weeks. In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
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|---|---|---|
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Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
Erythema score-Week 1
|
0.16 Score on a scale
Standard Deviation 0.83
|
0.00 Score on a scale
Standard Deviation 0.67
|
|
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
Erythema score -Week 2
|
-0.21 Score on a scale
Standard Deviation 0.54
|
-0.16 Score on a scale
Standard Deviation 0.76
|
|
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
Erythema score -Week 4
|
-0.37 Score on a scale
Standard Deviation 0.83
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-0.32 Score on a scale
Standard Deviation 0.89
|
|
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
Erythema score -Week 8
|
-0.32 Score on a scale
Standard Deviation 1.06
|
-0.32 Score on a scale
Standard Deviation 1.06
|
|
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
Dryness score-Week 1
|
0.11 Score on a scale
Standard Deviation 0.81
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0.00 Score on a scale
Standard Deviation 0.33
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|
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
Dryness score -Week 2
|
-0.11 Score on a scale
Standard Deviation 0.32
|
-0.11 Score on a scale
Standard Deviation 0.32
|
|
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
Dryness score -Week 4
|
-0.05 Score on a scale
Standard Deviation 0.40
|
-0.05 Score on a scale
Standard Deviation 0.40
|
|
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
Dryness score -Week 8
|
0.00 Score on a scale
Standard Deviation 0.47
|
0.05 Score on a scale
Standard Deviation 0.52
|
|
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
Peeling score-Week 1
|
0.05 Score on a scale
Standard Deviation 0.78
|
-0.11 Score on a scale
Standard Deviation 0.32
|
|
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
Peeling score -Week 2
|
-0.11 Score on a scale
Standard Deviation 0.32
|
-0.11 Score on a scale
Standard Deviation 0.32
|
|
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
Peeling score -Week 4
|
-0.05 Score on a scale
Standard Deviation 0.40
|
-0.05 Score on a scale
Standard Deviation 0.40
|
|
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
Peeling score -Week 8
|
-0.11 Score on a scale
Standard Deviation 0.32
|
-0.05 Score on a scale
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: Baseline and Week 1, 2, 4, 8Population: ITT analysis set. Only those participants with data available at the indicated time points were analyzed.
Redness, dryness, burning, itching and scaling were evaluated independently by the participant on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline. Baseline is defined as value at Day 1.
Outcome measures
| Measure |
MAXCLARITY II
n=19 Participants
MAXCLARITY II was a 2.5% BPO foam cleanser and foam treatment, 0.5% SA toner foam. It was applied topically to 1 side of face BD for 8 weeks. Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in AM and toner foam in PM.
|
Murad
n=19 Participants
Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. It was applied topically to 1 side of face BD for 8 weeks. In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
|
|---|---|---|
|
Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8.
Redness score-Week 1
|
-0.11 Score on a scale
Standard Deviation 0.88
|
-0.32 Score on a scale
Standard Deviation 0.48
|
|
Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8.
Redness score -Week 2
|
-0.11 Score on a scale
Standard Deviation 0.81
|
-0.26 Score on a scale
Standard Deviation 0.56
|
|
Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8.
Redness score -Week 4
|
-0.32 Score on a scale
Standard Deviation 0.58
|
-0.11 Score on a scale
Standard Deviation 1.15
|
|
Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8.
Redness score -Week 8
|
-0.42 Score on a scale
Standard Deviation 0.69
|
-0.26 Score on a scale
Standard Deviation 1.05
|
|
Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8.
Dryness score-Week 1
|
-0.21 Score on a scale
Standard Deviation 1.47
|
-0.11 Score on a scale
Standard Deviation 1.20
|
|
Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8.
Dryness score -Week 2
|
-0.16 Score on a scale
Standard Deviation 1.46
|
-0.26 Score on a scale
Standard Deviation 0.93
|
|
Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8.
Dryness score -Week 4
|
-0.37 Score on a scale
Standard Deviation 1.21
|
-0.11 Score on a scale
Standard Deviation 1.49
|
|
Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8.
Dryness score -Week 8
|
-0.42 Score on a scale
Standard Deviation 1.22
|
-0.11 Score on a scale
Standard Deviation 1.52
|
|
Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8.
Burning score-Week 1
|
0.11 Score on a scale
Standard Deviation 1.15
|
0.16 Score on a scale
Standard Deviation 1.12
|
|
Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8.
Burning score -Week 2
|
-0.11 Score on a scale
Standard Deviation 0.57
|
0.00 Score on a scale
Standard Deviation 0.88
|
|
Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8.
Burning score -Week 4
|
-0.26 Score on a scale
Standard Deviation 0.65
|
-0.05 Score on a scale
Standard Deviation 0.91
|
|
Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8.
Burning score -Week 8
|
-0.26 Score on a scale
Standard Deviation 0.87
|
0.00 Score on a scale
Standard Deviation 0.82
|
|
Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8.
Itching score-Week 1
|
-0.21 Score on a scale
Standard Deviation 0.71
|
0.00 Score on a scale
Standard Deviation 0.88
|
|
Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8.
Itching score -Week 2
|
0.00 Score on a scale
Standard Deviation 0.88
|
0.11 Score on a scale
Standard Deviation 0.94
|
|
Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8.
Itching score -Week 4
|
-0.26 Score on a scale
Standard Deviation 0.87
|
0.11 Score on a scale
Standard Deviation 1.24
|
|
Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8.
Itching score -Week 8
|
-0.21 Score on a scale
Standard Deviation 0.63
|
0.11 Score on a scale
Standard Deviation 1.10
|
|
Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8.
Scaling score-Week 1
|
0.05 Score on a scale
Standard Deviation 1.18
|
-0.11 Score on a scale
Standard Deviation 1.05
|
|
Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8.
Scaling score -Week 2
|
-0.26 Score on a scale
Standard Deviation 0.87
|
-0.26 Score on a scale
Standard Deviation 0.87
|
|
Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8.
Scaling score -Week 4
|
-0.16 Score on a scale
Standard Deviation 1.12
|
0.11 Score on a scale
Standard Deviation 1.49
|
|
Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8.
Scaling score -Week 8
|
0.11 Score on a scale
Standard Deviation 0.94
|
0.21 Score on a scale
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: Up to Week 8Population: ITT analysis set. Only those participants with data available at the indicated time points were analyzed.
During each study visit, investigators/expert grader evaluated the acne severity of participants' faces using the ISGA scale on right and left side of face on a five point scale from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Percent change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline is defined as value at Day 1.
Outcome measures
| Measure |
MAXCLARITY II
n=19 Participants
MAXCLARITY II was a 2.5% BPO foam cleanser and foam treatment, 0.5% SA toner foam. It was applied topically to 1 side of face BD for 8 weeks. Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in AM and toner foam in PM.
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Murad
n=19 Participants
Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. It was applied topically to 1 side of face BD for 8 weeks. In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
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Percentage of Participant Who Improved by at Least One Grade on the ISGA
One or more grade improvement-Week 1
|
10.5 Percentage of participants
|
10.5 Percentage of participants
|
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Percentage of Participant Who Improved by at Least One Grade on the ISGA
Two or more grade improvement-Week 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
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Percentage of Participant Who Improved by at Least One Grade on the ISGA
One or more grade improvement-Week 2
|
15.8 Percentage of participants
|
10.5 Percentage of participants
|
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Percentage of Participant Who Improved by at Least One Grade on the ISGA
Two or more grade improvement-Week 2
|
5.3 Percentage of participants
|
0.0 Percentage of participants
|
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Percentage of Participant Who Improved by at Least One Grade on the ISGA
One or more grade improvement-Week 4
|
47.4 Percentage of participants
|
57.9 Percentage of participants
|
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Percentage of Participant Who Improved by at Least One Grade on the ISGA
Two or more grade improvement-Week 4
|
5.3 Percentage of participants
|
0.0 Percentage of participants
|
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Percentage of Participant Who Improved by at Least One Grade on the ISGA
One or more grade improvement-Week 8
|
78.9 Percentage of participants
|
68.4 Percentage of participants
|
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Percentage of Participant Who Improved by at Least One Grade on the ISGA
Two or more grade improvement-Week 8
|
42.1 Percentage of participants
|
21.1 Percentage of participants
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Adverse Events
MAXCLARITY II + Murad
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MAXCLARITY II + Murad
n=20 participants at risk
MAXCLARITY II was a 2.5 percent (%) benzoyl peroxide (BPO) foam cleanser and foam treatment, 0.5% salicylic acid (SA) toner foam. Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. Both treatments were applied topically to 1 side of face twice daily (BD) for 8 weeks. MAXCLARITY II application: Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in ante meridiem (AM) and toner foam in post meridiem (PM). Murad application: In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
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|---|---|
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Infections and infestations
Nasopharyngitis
|
15.0%
3/20 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to Week 8)
An AE was an unintended or unfavorable sign, symptoms or disease, can include lack of efficacy, abuse or misuse. The SAE was an AE that results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect. ITT analysis set used.
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|
Infections and infestations
Influenza
|
10.0%
2/20 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to Week 8)
An AE was an unintended or unfavorable sign, symptoms or disease, can include lack of efficacy, abuse or misuse. The SAE was an AE that results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect. ITT analysis set used.
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Infections and infestations
Body tinea
|
5.0%
1/20 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to Week 8)
An AE was an unintended or unfavorable sign, symptoms or disease, can include lack of efficacy, abuse or misuse. The SAE was an AE that results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect. ITT analysis set used.
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|
Infections and infestations
Gastroenteritis viral
|
5.0%
1/20 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to Week 8)
An AE was an unintended or unfavorable sign, symptoms or disease, can include lack of efficacy, abuse or misuse. The SAE was an AE that results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect. ITT analysis set used.
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|
Infections and infestations
Sinusitis
|
5.0%
1/20 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to Week 8)
An AE was an unintended or unfavorable sign, symptoms or disease, can include lack of efficacy, abuse or misuse. The SAE was an AE that results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect. ITT analysis set used.
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Musculoskeletal and connective tissue disorders
Arthritis
|
5.0%
1/20 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to Week 8)
An AE was an unintended or unfavorable sign, symptoms or disease, can include lack of efficacy, abuse or misuse. The SAE was an AE that results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect. ITT analysis set used.
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Musculoskeletal and connective tissue disorders
Pain in jaw
|
5.0%
1/20 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to Week 8)
An AE was an unintended or unfavorable sign, symptoms or disease, can include lack of efficacy, abuse or misuse. The SAE was an AE that results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect. ITT analysis set used.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
5.0%
1/20 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to Week 8)
An AE was an unintended or unfavorable sign, symptoms or disease, can include lack of efficacy, abuse or misuse. The SAE was an AE that results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect. ITT analysis set used.
|
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Respiratory, thoracic and mediastinal disorders
Asthma
|
5.0%
1/20 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to Week 8)
An AE was an unintended or unfavorable sign, symptoms or disease, can include lack of efficacy, abuse or misuse. The SAE was an AE that results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect. ITT analysis set used.
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Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
5.0%
1/20 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to Week 8)
An AE was an unintended or unfavorable sign, symptoms or disease, can include lack of efficacy, abuse or misuse. The SAE was an AE that results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect. ITT analysis set used.
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Gastrointestinal disorders
Tooth caries
|
5.0%
1/20 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to Week 8)
An AE was an unintended or unfavorable sign, symptoms or disease, can include lack of efficacy, abuse or misuse. The SAE was an AE that results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect. ITT analysis set used.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
5.0%
1/20 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to Week 8)
An AE was an unintended or unfavorable sign, symptoms or disease, can include lack of efficacy, abuse or misuse. The SAE was an AE that results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect. ITT analysis set used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
5.0%
1/20 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to Week 8)
An AE was an unintended or unfavorable sign, symptoms or disease, can include lack of efficacy, abuse or misuse. The SAE was an AE that results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect. ITT analysis set used.
|
|
Nervous system disorders
Paraesthesia
|
5.0%
1/20 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to Week 8)
An AE was an unintended or unfavorable sign, symptoms or disease, can include lack of efficacy, abuse or misuse. The SAE was an AE that results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect. ITT analysis set used.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.0%
1/20 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to Week 8)
An AE was an unintended or unfavorable sign, symptoms or disease, can include lack of efficacy, abuse or misuse. The SAE was an AE that results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect. ITT analysis set used.
|
|
Surgical and medical procedures
Endodontic procedure
|
5.0%
1/20 • Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to Week 8)
An AE was an unintended or unfavorable sign, symptoms or disease, can include lack of efficacy, abuse or misuse. The SAE was an AE that results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect. ITT analysis set used.
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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