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Trial record 38 of 79 for:    acne AND almost AND facial

8 Week Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITY II and MURAD To Treat Acne

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ClinicalTrials.gov Identifier: NCT02524665
Recruitment Status : Completed
First Posted : August 17, 2015
Results First Posted : March 15, 2017
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Other: MAXCLARITY II (2.5% BPO) Foam Cleanser
Other: MAXCLARITY II (2.5% BPO) Foam Treatment
Other: MAXCLARITY II (0.5% Salicylic Acid) Toner Foam
Other: MURAD Clarifying Cleanser (1.5% SA)
Other: Exfoliating Acne Treatment Gel (1% SA)
Other: Skin Perfecting Lotion
Enrollment 20
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title MAXCLARITY II + Murad
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 20
Completed 19
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title MAXCLARITY II + Murad
Hide Arm/Group Description 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 Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
22.5  (4.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
10
  50.0%
Male
10
  50.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants
Black 7
White 13
1.Primary Outcome
Title Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 8.
Hide Description 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.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title MAXCLARITY II Murad
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: Percent change
Inflammatory lesion counts- Week 8, n=19, 17 -78.70  (40.93) -61.52  (47.59)
Non-inflammatory lesion counts- Week 8, n=19, 19 -69.32  (48.69) -77.09  (23.50)
Total lesion counts-Week 8, n=19, 19 -76.67  (30.79) -75.01  (23.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0769
Comments The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.67
Parameter Dispersion
Type: Standard Deviation
Value: 61.97
Estimation Comments Comparison of inflammatory lesion counts between MAXCLARITY II and Murad at Week 8.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6698
Comments The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.77
Parameter Dispersion
Type: Standard Deviation
Value: 33.73
Estimation Comments Comparison of non-inflammatory lesion counts between MAXCLARITY II and Murad at Week 8.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6854
Comments Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.66
Parameter Dispersion
Type: Standard Deviation
Value: 17.59
Estimation Comments Comparison of total lesion counts between MAXCLARITY II and Murad at Week 8.
2.Secondary Outcome
Title Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 1, 2 and 4.
Hide Description 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.
Time Frame Baseline and Week 1, 2, 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles).
Arm/Group Title MAXCLARITY II Murad
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: Percent change
Inflammatory lesion counts- Week 1, n=19, 17 -17.69  (38.89) -7.85  (83.21)
Inflammatory lesion counts- Week 2, n=19, 17 -46.69  (55.00) -14.25  (66.06)
Inflammatory lesion counts- Week 4, n=19, 17 -55.35  (46.13) -51.95  (47.60)
Non-inflammatory lesion counts- Week 1, n=19, 19 -4.94  (52.60) -15.92  (28.91)
Non-inflammatory lesion counts- Week 2, n=19, 19 -28.07  (48.27) -37.07  (28.42)
Non-inflammatory lesion counts- Week 4, n=19, 19 -52.85  (47.46) -60.27  (24.54)
Total lesion counts-Week 1, n=19, 19 -12.57  (27.27) -18.29  (23.53)
Total lesion counts-Week 2, n=19, 19 -37.06  (27.97) -35.84  (22.91)
Total lesion counts-Week 4, n=19, 19 -60.93  (26.94) -60.73  (22.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5031
Comments The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.10
Parameter Dispersion
Type: Standard Deviation
Value: 74.55
Estimation Comments Comparison of percent change inflammatory lesion counts between MAXCLARITY II and Murad at Week 1.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2464
Comments Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -29.11
Parameter Dispersion
Type: Standard Deviation
Value: 99.76
Estimation Comments Comparison of percent change inflammatory lesion counts between MAXCLARITY II and Murad at Week 2.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8894
Comments The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.03
Parameter Dispersion
Type: Standard Deviation
Value: 65.22
Estimation Comments Comparison of percent change inflammatory lesion counts between MAXCLARITY II and Murad at Week 4.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6722
Comments The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 10.98
Parameter Dispersion
Type: Standard Error of the Mean
Value: 46.04
Estimation Comments Comparison of percent change non-inflammatory lesion counts between MAXCLARITY II and Murad at Week 1.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3352
Comments Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.99
Parameter Dispersion
Type: Standard Deviation
Value: 39.59
Estimation Comments Comparison of percent change non-inflammatory lesion counts between MAXCLARITY II and Murad at Week 2.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9323
Comments The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.41
Parameter Dispersion
Type: Standard Deviation
Value: 35.46
Estimation Comments Comparison of percent change non-inflammatory lesion counts between MAXCLARITY II and Murad at Week 4.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3513
Comments Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.72
Parameter Dispersion
Type: Standard Deviation
Value: 26.05
Estimation Comments Comparison of percent change total lesion counts between MAXCLARITY II and Murad at Week 1.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8199
Comments Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.22
Parameter Dispersion
Type: Standard Deviation
Value: 22.97
Estimation Comments Comparison of percent change total lesion counts between MAXCLARITY II and Murad at Week 2.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9616
Comments Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.20
Parameter Dispersion
Type: Standard Deviation
Value: 17.83
Estimation Comments Comparison of percent change total lesion counts between MAXCLARITY II and Murad at Week 4.
3.Secondary Outcome
Title Mean Change in Investigator's Static Global Assessment (ISGA) From Baseline to Week 1, 2, 4 and 8
Hide Description 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.
Time Frame Baseline and Week 1, 2, 4, 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set. Only those participants available at the indicated time points were analyzed.
Arm/Group Title MAXCLARITY II Murad
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: Score on a scale
ISGA score-Week 1 -0.05  (0.40) -0.11  (0.32)
ISGA score -Week 2 -0.16  (0.60) -0.05  (0.40)
ISGA score -Week 4 -0.47  (0.70) -0.58  (0.51)
ISGA score -Week 8 -1.16  (0.90) -0.89  (0.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.05
Parameter Dispersion
Type: Standard Deviation
Value: 0.23
Estimation Comments Comparison of ISGA score between MAXCLARITY II and Murad at Week 1
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7500
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.11
Parameter Dispersion
Type: Standard Deviation
Value: 0.66
Estimation Comments Comparison of ISGA score between MAXCLARITY II and Murad at Week 2.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7539
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.11
Parameter Dispersion
Type: Standard Deviation
Value: 0.74
Estimation Comments Comparison of ISGA score between MAXCLARITY II and Murad at Week 4.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3071
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.26
Parameter Dispersion
Type: Standard Deviation
Value: 0.87
Estimation Comments Comparison of ISGA score between MAXCLARITY II and Murad at Week 8
4.Secondary Outcome
Title Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
Hide Description 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.
Time Frame Baseline and Week 1, 2, 4, 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title MAXCLARITY II Murad
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Erythema score-Week 1 0.16  (0.83) 0.00  (0.67)
Erythema score -Week 2 -0.21  (0.54) -0.16  (0.76)
Erythema score -Week 4 -0.37  (0.83) -0.32  (0.89)
Erythema score -Week 8 -0.32  (1.06) -0.32  (1.06)
Dryness score-Week 1 0.11  (0.81) 0.00  (0.33)
Dryness score -Week 2 -0.11  (0.32) -0.11  (0.32)
Dryness score -Week 4 -0.05  (0.40) -0.05  (0.40)
Dryness score -Week 8 0.00  (0.47) 0.05  (0.52)
Peeling score-Week 1 0.05  (0.78) -0.11  (0.32)
Peeling score -Week 2 -0.11  (0.32) -0.11  (0.32)
Peeling score -Week 4 -0.05  (0.40) -0.05  (0.40)
Peeling score -Week 8 -0.11  (0.32) -0.05  (0.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5000
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.16
Parameter Dispersion
Type: Standard Deviation
Value: 0.50
Estimation Comments Comparison of Erythema score between MAXCLARITY II and Murad at Week 1.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.05
Parameter Dispersion
Type: Standard Deviation
Value: 0.52
Estimation Comments Comparison of Erythema score between MAXCLARITY II and Murad at Week 2.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.05
Parameter Dispersion
Type: Standard Deviation
Value: 0.23
Estimation Comments Comparison of Erythema score between MAXCLARITY II and Murad at Week 4.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0
Comments The value is mentioned as '0', as no P-value generated.
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Parameter Dispersion
Type: Standard Deviation
Value: 0.00
Estimation Comments Comparison of Erythema score between MAXCLARITY II and Murad at Week 8.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.11
Parameter Dispersion
Type: Standard Deviation
Value: 0.74
Estimation Comments Comparison of Dryness score between MAXCLARITY II and Murad at Week 1.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0
Comments The value is mentioned as '0', as no P-value generated.
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Parameter Dispersion
Type: Standard Deviation
Value: 0.00
Estimation Comments Comparison of Dryness score between MAXCLARITY II and Murad at Week 2.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0
Comments The value is mentioned as '0', as no P-value generated.
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Parameter Dispersion
Type: Standard Deviation
Value: 0.00
Estimation Comments Comparison of Dryness score between MAXCLARITY II and Murad at Week 4.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.05
Parameter Dispersion
Type: Standard Deviation
Value: 0.23
Estimation Comments Comparison of Dryness score between MAXCLARITY II and Murad at Week 8.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.16
Parameter Dispersion
Type: Standard Deviation
Value: 0.69
Estimation Comments Comparison of Peeling score between MAXCLARITY II and Murad at Week 1.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0
Comments The value is mentioned as '0', as no P-value generated.
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Parameter Dispersion
Type: Standard Deviation
Value: 0.00
Estimation Comments Comparison of Peeling score between MAXCLARITY II and Murad at Week 2.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0
Comments The value is mentioned as '0', as no P-value generated.
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Parameter Dispersion
Type: Standard Deviation
Value: 0.00
Estimation Comments Comparison of Peeling score between MAXCLARITY II and Murad at Week 4.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.05
Parameter Dispersion
Type: Standard Deviation
Value: 0.23
Estimation Comments Comparison of Peeling score between MAXCLARITY II and Murad at Week 8.
5.Secondary Outcome
Title Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8.
Hide Description 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.
Time Frame Baseline and Week 1, 2, 4, 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title MAXCLARITY II Murad
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Redness score-Week 1 -0.11  (0.88) -0.32  (0.48)
Redness score -Week 2 -0.11  (0.81) -0.26  (0.56)
Redness score -Week 4 -0.32  (0.58) -0.11  (1.15)
Redness score -Week 8 -0.42  (0.69) -0.26  (1.05)
Dryness score-Week 1 -0.21  (1.47) -0.11  (1.20)
Dryness score -Week 2 -0.16  (1.46) -0.26  (0.93)
Dryness score -Week 4 -0.37  (1.21) -0.11  (1.49)
Dryness score -Week 8 -0.42  (1.22) -0.11  (1.52)
Burning score-Week 1 0.11  (1.15) 0.16  (1.12)
Burning score -Week 2 -0.11  (0.57) 0.00  (0.88)
Burning score -Week 4 -0.26  (0.65) -0.05  (0.91)
Burning score -Week 8 -0.26  (0.87) 0.00  (0.82)
Itching score-Week 1 -0.21  (0.71) 0.00  (0.88)
Itching score -Week 2 0.00  (0.88) 0.11  (0.94)
Itching score -Week 4 -0.26  (0.87) 0.11  (1.24)
Itching score -Week 8 -0.21  (0.63) 0.11  (1.10)
Scaling score-Week 1 0.05  (1.18) -0.11  (1.05)
Scaling score -Week 2 -0.26  (0.87) -0.26  (0.87)
Scaling score -Week 4 -0.16  (1.12) 0.11  (1.49)
Scaling score -Week 8 0.11  (0.94) 0.21  (1.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5000
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.21
Parameter Dispersion
Type: Standard Deviation
Value: 0.63
Estimation Comments Comparison of Redness score between MAXCLARITY II and Murad at Week 1.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5000
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.16
Parameter Dispersion
Type: Standard Deviation
Value: 0.50
Estimation Comments Comparison of Redness score between MAXCLARITY II and Murad at Week 2.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.21
Parameter Dispersion
Type: Standard Deviation
Value: 0.92
Estimation Comments Comparison of Redness score between MAXCLARITY II and Murad at Week 4.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.16
Parameter Dispersion
Type: Standard Deviation
Value: 0.69
Estimation Comments Comparison of Redness score between MAXCLARITY II and Murad at Week 8.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8125
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.11
Parameter Dispersion
Type: Standard Deviation
Value: 0.88
Estimation Comments Comparison of Dryness score between MAXCLARITY II and Murad at Week 1.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5742
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.11
Parameter Dispersion
Type: Standard Deviation
Value: 0.94
Estimation Comments Comparison of Dryness score between MAXCLARITY II and Murad at Week 2.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5000
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.26
Parameter Dispersion
Type: Standard Deviation
Value: 0.93
Estimation Comments Comparison of Dryness score between MAXCLARITY II and Murad at Week 4.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2500
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.32
Parameter Dispersion
Type: Standard Deviation
Value: 0.82
Estimation Comments Comparison of Dryness score between MAXCLARITY II and Murad at Week 8.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.05
Parameter Dispersion
Type: Standard Deviation
Value: 0.62
Estimation Comments Comparison of Burning score between MAXCLARITY II and Murad at Week 1.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7500
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.11
Parameter Dispersion
Type: Standard Deviation
Value: 0.74
Estimation Comments Comparison of Burning score between MAXCLARITY II and Murad at Week 2.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7500
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.21
Parameter Dispersion
Type: Standard Deviation
Value: 0.98
Estimation Comments Comparison of Burning score between MAXCLARITY II and Murad at Week 4.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2500
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.26
Parameter Dispersion
Type: Standard Deviation
Value: 0.73
Estimation Comments Comparison of Burning score between MAXCLARITY II and Murad at Week 8.
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2500
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.21
Parameter Dispersion
Type: Standard Deviation
Value: 0.54
Estimation Comments Comparison of Itching score between MAXCLARITY II and Murad at Week 1.
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7500
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.11
Parameter Dispersion
Type: Standard Deviation
Value: 0.74
Estimation Comments Comparison of Itching score between MAXCLARITY II and Murad at Week 2.
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2500
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.37
Parameter Dispersion
Type: Standard Deviation
Value: 1.01
Estimation Comments Comparison of Itching score between MAXCLARITY II and Murad at Week 4.
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2500
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.32
Parameter Dispersion
Type: Standard Deviation
Value: 0.82
Estimation Comments Comparison of Itching score between MAXCLARITY II and Murad at Week 8.
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5000
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.16
Parameter Dispersion
Type: Standard Deviation
Value: 0.50
Estimation Comments Comparison of Scaling score between MAXCLARITY II and Murad at Week 1.
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0
Comments The value is mentioned as '0', as no P-value generated.
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Parameter Dispersion
Type: Standard Deviation
Value: 0.00
Estimation Comments Comparison of Scaling score between MAXCLARITY II and Murad at Week 2.
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5000
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.26
Parameter Dispersion
Type: Standard Deviation
Value: 0.93
Estimation Comments Comparison of Scaling score between MAXCLARITY II and Murad at Week 4.
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.11
Parameter Dispersion
Type: Standard Deviation
Value: 0.81
Estimation Comments Comparison of Scaling score between MAXCLARITY II and Murad at Week 8.
6.Secondary Outcome
Title Percentage of Participant Who Improved by at Least One Grade on the ISGA
Hide Description 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.
Time Frame Up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title MAXCLARITY II Murad
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Measure Type: Number
Unit of Measure: Percentage of participants
One or more grade improvement-Week 1 10.5 10.5
Two or more grade improvement-Week 1 0.0 0.0
One or more grade improvement-Week 2 15.8 10.5
Two or more grade improvement-Week 2 5.3 0.0
One or more grade improvement-Week 4 47.4 57.9
Two or more grade improvement-Week 4 5.3 0.0
One or more grade improvement-Week 8 78.9 68.4
Two or more grade improvement-Week 8 42.1 21.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments Comparison of one or more grade improvement between MAXCLARITY II and Murad at Week 1.
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0
Comments The value is mentioned as '0', as no P-value generated. Comparison of two or more grade improvement between MAXCLARITY II and Murad at Week 1.
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5637
Comments Comparison of one or more grade improvement between MAXCLARITY II and Murad at Week 2.
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments Comparison of two or more grade improvement between MAXCLARITY II and Murad at Week 2.
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4795
Comments Comparison of one or more grade improvement between MAXCLARITY II and Murad at Week 4.
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments Comparison of two or more grade improvement between MAXCLARITY II and Murad at Week 4.
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3173
Comments Comparison of one or more grade improvement between MAXCLARITY II and Murad at Week 8.
Method McNemar
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, Murad
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1573
Comments Comparison of two or more grade improvement between MAXCLARITY II and Murad at Week 8.
Method McNemar
Comments [Not Specified]
Time Frame Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to Week 8)
Adverse Event Reporting Description 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.
 
Arm/Group Title MAXCLARITY II + Murad
Hide Arm/Group Description 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.
All-Cause Mortality
MAXCLARITY II + Murad
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MAXCLARITY II + Murad
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MAXCLARITY II + Murad
Affected / at Risk (%)
Total   10/20 (50.00%) 
Gastrointestinal disorders   
Tooth caries  1/20 (5.00%) 
Infections and infestations   
Nasopharyngitis  3/20 (15.00%) 
Influenza  2/20 (10.00%) 
Body tinea  1/20 (5.00%) 
Gastroenteritis viral  1/20 (5.00%) 
Sinusitis  1/20 (5.00%) 
Injury, poisoning and procedural complications   
Road traffic accident  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders   
Arthritis  1/20 (5.00%) 
Pain in jaw  1/20 (5.00%) 
Spinal osteoarthritis  1/20 (5.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Melanocytic naevus  1/20 (5.00%) 
Nervous system disorders   
Paraesthesia  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Asthma  1/20 (5.00%) 
Upper respiratory tract congestion  1/20 (5.00%) 
Skin and subcutaneous tissue disorders   
Dermatitis  1/20 (5.00%) 
Surgical and medical procedures   
Endodontic procedure  1/20 (5.00%) 
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT02524665     History of Changes
Other Study ID Numbers: 114553
First Submitted: August 13, 2015
First Posted: August 17, 2015
Results First Submitted: January 24, 2017
Results First Posted: March 15, 2017
Last Update Posted: April 13, 2017