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U0289-401: Eight Week, Split-face, Study to Determine and Compare the Efficacy and Tolerability of MAXCLARITY™ II to PROACTIV™

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ClinicalTrials.gov Identifier: NCT01706250
Recruitment Status : Completed
First Posted : October 15, 2012
Results First Posted : June 20, 2017
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group 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: PROACTIV (2.5% BPO) Renewing Cleanser
Other: PROACTIV (2.5% BPO) Repairing Lotion
Other: PROACTIV (2.5% BPO) Revitalizing Toner
Enrollment 20
Recruitment Details A total of 20 participants were enrolled to an evaluator-blinded, split-face study of acne, which was conducted at two centers in United States from 08 September 2009 to 25 January 2010.
Pre-assignment Details Same 20 participants were used in the split face study for the 2 interventions namely MaxClarity and Proactiv carried out in a single period.
Arm/Group Title MAXCLARITY II + PROACTIV
Hide Arm/Group Description This was a split face study, wherein the participants, each morning washed their face with MaxClarity II foam cleanser on 1 side of the face and Proactive renewing cleanser on the other side of the face. The face was patted dry the MaxClarity II foam treatment was applied to the MaxClarity II side of the face and on the proactive side, the participant applied the Revitalizing toner and then the Repairing lotion. The same was repeated in the evening, where the participants washed their face with MaxClarity II foam cleanser on 1 side and Proactiv renewing cleanser on the other side of the face. On the Proactiv side, the participant will apply the Revitalizing toner and then the Repairing lotion.
Period Title: Overall Study
Started 20
Completed 18
Not Completed 2
Reason Not Completed
Lost to Follow-up             2
Arm/Group Title MAXCLARITY II + PROACTIV
Hide Arm/Group Description This was a split face study, wherein the participants, each morning washed their face with MaxClarity II foam cleanser on 1 side of the face and Proactive renewing cleanser on the other side of the face. The face was patted dry the MaxClarity II foam treatment was applied to the MaxClarity II side of the face and on the proactive side, the participant applied the Revitalizing toner and then the Repairing lotion. The same was repeated in the evening, where the participants washed their face with MaxClarity II foam cleanser on 1 side and Proactiv renewing cleanser on the other side of the face. On the Proactiv side, the participant will apply the Revitalizing toner and then the Repairing 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
21.5  (3.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
16
  80.0%
Male
4
  20.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Asian
1
   5.0%
Black
6
  30.0%
White
13
  65.0%
1.Primary Outcome
Title Mean Percent Change in Inflammatory Lesion (IL), Non-inflammatory Lesion (NIL), and Total Lesion (TL) Counts From Baseline (BL) (Day 1) to Week (Wk) 8.
Hide Description This was an efficacy variable. An expert grader evaluated each side of the face (included forehead, cheeks and chin), the left and the right side, for IL (presence of papules and pustules), NIL (presence of open and closed comedones) and the TLs. The mouth, nose, periocular area, nasogenian, and superior and inferior eyelids were excluded. The evaluator was also blinded. BL was defined as Day 1. The percent change was calculated as the value at Wk 8 minus the value at BL.
Time Frame BL (Day 1) and Wk 8
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent to treat (ITT) analysis set included data from all randomized participants who received the study drug. The number of participants available at that particular time point were used for analysis.
Arm/Group Title MAXCLARITY II PROACTIV
Hide Arm/Group Description:
MAXCLARITY II (2.5% benzyl peroxide [BPO]) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (the side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wk, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: percent change in lesion count
Percent change, IL count -55.93  (32.72) -52.64  (29.23)
Percent change, NIL count -37.97  (38.72) -45.66  (23.05)
Percent change in TL count -45.46  (27.24) -47.69  (21.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Percent change for IL count for MAXCLARITY II Vs PROACTIV at Wk 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6779
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.29
Parameter Dispersion
Type: Standard Deviation
Value: 32.98
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Percent change for NIL count for MAXCLARITY II Vs PROACTIV at Wk 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2847
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 7.68
Parameter Dispersion
Type: Standard Deviation
Value: 29.51
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Percent change for TL count for MAXCLARITY II Vs PROACTIV at Wk 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6894
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 2.24
Parameter Dispersion
Type: Standard Deviation
Value: 23.35
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Percent Change in IL Count From BL (Day 1) to Wks 1, 2 and 4
Hide Description This was an efficacy variable. An expert grader (blinded) evaluated the left and the right side of the face extending from the hairline to the mandible (included forehead, cheeks and chin). The evaluator assessed the IL by counting the number of papules and pustules. The mouth, nose, periocular area, nasogenian, and superior and inferior eyelids were excluded. BL was defined as Day 1. The percent change was calculated as the percent value (count of IL) at each individual visit (percent value at wk 1, 2 and 4) minus the value at BL respectively.
Time Frame BL (Day1) to Wks 1, 2 and 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT used. Only those participants available at the specified time points were analyzed (re presented by n=x, x in the category titles).
Arm/Group Title MAXCLARITY II PROACTIV
Hide Arm/Group Description:
MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wk. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wk, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: percent change in lesion count
Percent change, IL count, BL to Wk 1 Number Analyzed 20 participants 19 participants
-17.56  (33.63) -19.93  (26.39)
Percent change, IL count, BL to Wk 2 Number Analyzed 19 participants 19 participants
-35.64  (37.66) -31.64  (30.06)
Percent change, IL count, BL to Wk 4 Number Analyzed 19 participants 19 participants
-21.35  (63.62) -44.99  (37.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Percent change for MAXCLARITY II Vs PROACTIV: IL count, BL to Wk 1 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9909
Comments [Not Specified]
Method Signed Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.38
Parameter Dispersion
Type: Standard Deviation
Value: 50.10
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments IL count for MAXCLARITY II Vs PROACTIV- BL to Wk 2 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6671
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -4.0
Parameter Dispersion
Type: Standard Deviation
Value: 39.91
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Percent change for MAXCLARITY II Vs PROACTIV: IL count, BL to Wk 4 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0632
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 23.64
Parameter Dispersion
Type: Standard Deviation
Value: 52.05
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mean Percent Change in NIL Count From BL (Day 1) to Wks 1, 2 and 4
Hide Description This was an efficacy variable. An expert grader (blinded) evaluated the left and the right side of the face extending from the hairline to the mandible (included forehead, cheeks and chin). The evaluator assessed the NIL by the presence of open and closed comedones. The mouth, nose, periocular area, nasogenian, and superior and inferior eyelids were excluded. BL was defined as Day 1. The percent change was calculated as the percent value (count of NIL) at each individual visit (percent value at Wk 1, 2 and 4) minus the value at BL respectively.
Time Frame BL (Day 1) to Wks 1, 2 and 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. 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 PROACTIV
Hide Arm/Group Description:
MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: percent change in lesion count
Percent change, NIL count, BL to Wk 1 Number Analyzed 20 participants 20 participants
-3.92  (32.71) -7.13  (25.91)
Percent change, NIL count, BL to Wk 2 Number Analyzed 19 participants 19 participants
-24.12  (37.73) -21.07  (26.17)
Percent change, NIL count, BL to Wk 4 Number Analyzed 19 participants 19 participants
-30.26  (38.48) -37.76  (22.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Percent change for MAXCLARITY II Vs PROACTIV: NIL count, BL to Wk 1 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7385
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.20
Parameter Dispersion
Type: Standard Deviation
Value: 42.31
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Percent change for MAXCLARITY II Vs PROACTIV: NIL count, BL to Wk 2 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7296
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.04
Parameter Dispersion
Type: Standard Deviation
Value: 37.77
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Percent change for MAXCLARITY II Vs PROACTIV: NIL count, BL to Wk 4 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3774
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.50
Parameter Dispersion
Type: Standard Deviation
Value: 36.11
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Mean Percent Change in TL Count From BL (Day 1) to Wks 1, 2 and 4
Hide Description This was an efficacy variable. An expert grader (blinded) evaluated the left and the right side of the face extending from the hairline to the mandible (included forehead, cheeks and chin). The evaluator assessed the total lesions by the sum of both inflammatory and non-inflammatory lesions on each side (left side and right side). The mouth, nose, periocular area, nasogenian, and superior and inferior eyelids were excluded. BL was defined as Day 1. The percent change was calculated as the percent value (count of total lesions) at each individual visit (percent value at Wks 1, 2 and 4) minus the value at baseline respectively.
Time Frame BL (Day 1) to Wks 1, 2 and 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants available at the specified time points we re analyze d (represented by n=X, X in the category titles).
Arm/Group Title MAXCLARITY II PROACTIV
Hide Arm/Group Description:
MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: percent change in lesion count
Percent change, in TL count, BL to Wk 1 Number Analyzed 20 participants 20 participants
-11.34  (21.84) -13.36  (19.07)
Percent change, in TL count, BL to Wk 2 Number Analyzed 19 participants 19 participants
-31.94  (27.86) -26.19  (20.23)
Percent change, in TL count, BL to Wk 4 Number Analyzed 19 participants 19 participants
-34.17  (28.06) -41.17  (20.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Percent change for MAXCLARITY II Vs PROACTIV: TL count, BL to Wk 1 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7634
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.02
Parameter Dispersion
Type: Standard Deviation
Value: 29.53
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Percent change for MAXCLARITY II Vs PROACTIV: TL count, BL to Wk 2 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4087
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -5.75
Parameter Dispersion
Type: Standard Deviation
Value: 29.61
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Percent change for MAXCLARITY II Vs PROACTIV: TL count, BL to Wk 4 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2455
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 7.00
Parameter Dispersion
Type: Standard Deviation
Value: 25.40
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Mean Change in Investigator’s Static Global Assessment (ISGA) From BL (Day 1) to Wks 1, 2, 4 and 8.
Hide Description The evaluator (blinded) evaluated the acne severity of the participants' face using the ISGA scale ranging from 0 to 5. The grading was 0= Clear, skin with no IL or NILs; 1= Almost clear, rare NILs with no more than one small IL ; 2= Mild, some NILs with no more than few ILs (papules/pustules only, no nodular lesions); 3= Moderate Upto many NILs and may have some ILs but no more than one small nodular lesion ; 4= Severe, Upto many NILs and ILs but no more than a few nodular lesions; 5= Very severe, many NILS and ILs more than a few nodular lesions, may have cystic lesions. Thus higher score indicated severity of the disease. BL was defined as Day 1. The mean change was calculated as value at each visit (Wks 1,2,4 and 8) minus the value at BL respectively.
Time Frame BL (Day 1) to Wks 1, 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants available at the specified time points we re analyze d (represented by n=x, x in the category titles).
Arm/Group Title MAXCLARITY II PROACTIV
Hide Arm/Group Description:
MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on scale
Change, in ISGA from BL to Wk 1 Number Analyzed 20 participants 20 participants
-0.10  (0.31) -0.05  (0.39)
Change, in ISGA from BL to Wk 2 Number Analyzed 19 participants 19 participants
-0.47  (0.61) -0.21  (0.54)
Change, in ISGA from BL to Wk 4 Number Analyzed 19 participants 19 participants
-0.53  (0.51) -0.42  (0.61)
Change, in ISGA from BL to Wk 8 Number Analyzed 18 participants 18 participants
-0.39  (0.61) -0.39  (0.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in ISGA for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Signed Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.05
Parameter Dispersion
Type: Standard Deviation
Value: 0.39
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in ISGA for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1250
Comments [Not Specified]
Method Signed Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.26
Parameter Dispersion
Type: Standard Deviation
Value: 0.56
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in ISGA for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6250
Comments [Not Specified]
Method Signed Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.11
Parameter Dispersion
Type: Standard Deviation
Value: 0.46
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in ISGA for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Signed Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.00
Parameter Dispersion
Type: Standard Deviation
Value: 0.59
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Mean Change in Each of the Evaluator Tolerability Assessments-Erythema
Hide Description This was a tolerability variable. The expert grader (blinded evaluator) assessed each left and right side of the face individually at each study visit. The areas on the face excluding nose, nasogenian, and superior and inferior eyelids were evaluated. The evaluator conducting the assessment for the participant remained blinded for the treatment assigned. Erythema is condition characterized by redness or rash on the skin. The assessment of the erythema was graded on 0 to 5 scale based on severity by the evaluator. 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated severity of the disease. BL was defined as Day 1. The mean change was calculated as value at each individual visit (wk 1,2,4 and 8) minus the value at BL respectively. The change from BL was '0' for Wk 4 and Wk 8, and hence statistical analysis was not done.
Time Frame BL (Day 1) to Wks 1, 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants available at the specified time points we re analyze d (represented by n=X, X in the category titles).
Arm/Group Title MAXCLARITY II PROACTIV
Hide Arm/Group Description:
MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-weeks (Wk). The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wk, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on scale
Erythema; Change from BL to Wk 1 Number Analyzed 20 participants 20 participants
0.05  (0.51) -0.05  (0.22)
Erythema; Change from BL to Wk 2 Number Analyzed 19 participants 19 participants
-0.05  (0.23) -0.11  (0.32)
Erythema; Change from BL to Wk 4 Number Analyzed 19 participants 19 participants
0.05  (0.40) 0.05  (0.40)
Erythema; Change from BL to Wk 8 Number Analyzed 18 participants 18 participants
0.06  (0.42) 0.06  (0.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in Erythema for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Signed Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.10
Parameter Dispersion
Type: Standard Deviation
Value: 0.45
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in Erythema for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Signed Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Signed Rank
Estimated Value 0.05
Parameter Dispersion
Type: Standard Deviation
Value: 0.23
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Mean Change in Each of the Evaluator Tolerability Assessments-Dryness
Hide Description This was a tolerability variable. The expert grader (blinded evaluator) assessed each left and right side of the face individually at each study visit. The areas on the face excluding nose, nasogenian, and superior and inferior eyelids were evaluated. The evaluator conducting the assessment for the participant remained blinded for the treatment assigned. The assessment of the dryness was graded on 0 to 5 scale based on severity by the evaluator. 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wk 1,2,4 and 8) minus the value at baseline respectively. The change from BL was '0' for Wk 2, Wk 4, and Wk 8 and hence statistical analysis was not done.
Time Frame BL (Day 1) to Wks 1, 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants available at the specified time points we re analyze d (represented by n=X, X in the category titles).
Arm/Group Title MAXCLARITY II PROACTIV
Hide Arm/Group Description:
MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on scale
Dryness; Change from BL to Wk 1 Number Analyzed 20 participants 20 participants
0.15  (0.49) 0.10  (0.45)
Dryness; Change from BL to Wk 2 Number Analyzed 19 participants 19 participants
0.00  (0.00) 0.00  (0.00)
Dryness; Change from BL to Wk 4 Number Analyzed 19 participants 19 participants
0.05  (0.23) 0.00  (0.00)
Dryness; Change from BL to Wk 8 Number Analyzed 18 participants 18 participants
0.11  (0.32) 0.11  (0.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Signed Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.05
Parameter Dispersion
Type: Standard Deviation
Value: 0.22
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Signed rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.05
Parameter Dispersion
Type: Standard Deviation
Value: 0.23
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Mean Change in Each of the Evaluator Tolerability Assessments-Peeling
Hide Description This was a tolerability variable. The expert grader (blinded evaluator) assessed each left and right side of the face individually at each study visit. The areas on the face excluding nose, nasogenian, and superior and inferior eyelids were evaluated. The evaluator conducting the assessment for the participant remained blinded for the treatment assigned. The assessment of the peeling was graded on 0 to 5 scale based on severity by the evaluator. 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wk 1,2,4 and 8) minus the value at BL respectively. The change from BL was '0' for Wk (1, 4 and 8) and hence statistical analysis was not done.
Time Frame BL (Day 1) to Wks 1, 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants available at the specified time points were analyze d (represented by n=x, x in the category titles).
Arm/Group Title MAXCLARITY II PROACTIV
Hide Arm/Group Description:
MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on scale
Peeling; Change from BL to Wk 1 Number Analyzed 20 participants 20 participants
0.00  (0.00) 0.00  (0.00)
Peeling; Change from BL to Wk 2 Number Analyzed 19 participants 19 participants
0.00  (0.00) 0.11  (0.46)
Peeling; Change from BL to Wk 4 Number Analyzed 19 participants 19 participants
0.00  (0.00) 0.00  (0.00)
Peeling; Change from BL to Wk 8 Number Analyzed 18 participants 18 participants
0.00  (0.00) 0.00  (0.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in Peeling, for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Signed rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.11
Parameter Dispersion
Type: Standard Deviation
Value: 0.46
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Mean Change in Each of the Participant Tolerability Assessments-Redness
Hide Description This was a tolerability variable, where the participants were instructed to individually assess the right and the left side of the face to indicate the severity that they had experienced during the time period from their last visit for redness. The area on the face was assessed excluding the excluding nose, nasogenian, and superior and inferior eyelids. The assessment of the redness was graded on 0 to 5 scale based on severity by the participant. 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wks 1,2,4 and 8) minus the value at BL respectively.
Time Frame BL (Day 1) to Wks 1, 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants available at the specified time points we re analyze d (represented by n=x, x in the category titles).
Arm/Group Title MAXCLARITY II PROACTIV
Hide Arm/Group Description:
MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on scale
Redness; Change from BL to Wk 1 Number Analyzed 20 participants 20 participants
0.50  (1.00) 0.35  (0.81)
Redness; Change from BL to Wk 2 Number Analyzed 19 participants 19 participants
0.37  (1.01) 0.21  (0.79)
Redness; Change from BL to Wk 4 Number Analyzed 18 participants 18 participants
0.72  (1.13) 0.56  (0.86)
Redness; Change from BL to Wk 8 Number Analyzed 18 participants 18 participants
0.61  (1.14) 0.28  (0.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in Redness for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5313
Comments [Not Specified]
Method Signed Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.15
Parameter Dispersion
Type: Standard Deviation
Value: 0.67
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in Redness for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5000
Comments [Not Specified]
Method Signed Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 0.16
Parameter Dispersion
Type: Standard Deviation
Value: 0.60
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in Redness for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7500
Comments [Not Specified]
Method Signed Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.17
Parameter Dispersion
Type: Standard Deviation
Value: 0.86
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in Redness for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2500
Comments [Not Specified]
Method Signed rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.33
Parameter Dispersion
Type: Standard Deviation
Value: 0.84
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Mean Change in Each of the Participant Assessments of Tolerability-Dryness
Hide Description This was a tolerability variable, where the participants were instructed to individually assess the right and the left side of the face to indicate the severity that they had experienced during the time period from their last visit for dryness. The area on the face was assessed excluding the excluding nose, nasogenian, and superior and inferior eyelids. The assessment of the dryness was graded on 0 to 5 scale based on severity by the participant. 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated severity of the disease. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wks 1,2,4 and 8) minus the value at BL respectively.
Time Frame BL (Day 1) to Wks 1, 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population . Only those participants available at the specified time points we re analyze d (represented by n=x, x in the category titles).
Arm/Group Title MAXCLARITY II PROACTIV
Hide Arm/Group Description:
MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on scale
Dryness; Change from BL to Wk 1 Number Analyzed 20 participants 20 participants
1.20  (1.24) 0.90  (1.07)
Dryness; Change from BL to Wk 2 Number Analyzed 19 participants 19 participants
1.05  (1.39) 0.68  (1.16)
Dryness; Change from BL to Wk 4 Number Analyzed 18 participants 18 participants
1.33  (1.14) 1.06  (1.00)
Dryness; Change from BL to Wk 8 Number Analyzed 18 participants 18 participants
1.33  (1.24) 1.11  (1.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2131
Comments [Not Specified]
Method Signed Rank)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.30
Parameter Dispersion
Type: Standard Deviation
Value: 0.86
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2656
Comments [Not Specified]
Method Signed Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.37
Parameter Dispersion
Type: Standard Deviation
Value: 1.16
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2344
Comments [Not Specified]
Method Signed Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.28
Parameter Dispersion
Type: Standard Deviation
Value: 0.75
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3594
Comments [Not Specified]
Method Signed Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.22
Parameter Dispersion
Type: Standard Deviation
Value: 0.73
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Mean Change in Each of the Participant Assessments of Tolerability-Burning
Hide Description This was a tolerability variable, where the participants were instructed to individually assess the right and the left side of the face to indicate the severity that they had experienced during the time period from their last visit for burning. The area on the face was assessed excluding nose, nasogenian, and superior and inferior eyelids. The assessment of the burning was graded on 0 to 5 scale based on severity by the participant; 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wks 1, 2, 4 and 8) minus the value at BL respectively.
Time Frame BL (Day 1) to Wks 1,2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants available at the specified time points we re analyze d (represented by n=x, x in the category titles).
Arm/Group Title MAXCLARITY II PROACTIV
Hide Arm/Group Description:
MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on scale
Burning; Change from BL to Wk 1 Number Analyzed 20 participants 20 participants
0.95  (1.28) 0.75  (0.85)
Burning; Change from BL to Wk 2 Number Analyzed 19 participants 19 participants
0.84  (1.17) 0.58  (0.84)
Burning; Change from BL to Wk 4 Number Analyzed 18 participants 18 participants
1.00  (1.08) 0.44  (0.62)
Burning; Change from BL to Wk 8 Number Analyzed 18 participants 20 participants
0.83  (1.34) 0.44  (0.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in Burning for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6172
Comments [Not Specified]
Method Signed Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.20
Parameter Dispersion
Type: Standard Deviation
Value: 1.32
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in Burning for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3984
Comments [Not Specified]
Method Signed Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.26
Parameter Dispersion
Type: Standard Deviation
Value: 0.93
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in Burning for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0781
Comments [Not Specified]
Method Signed Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.56
Parameter Dispersion
Type: Standard Deviation
Value: 1.10
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in Burning for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3750
Comments [Not Specified]
Method Signed Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.39
Parameter Dispersion
Type: Standard Deviation
Value: 1.24
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Mean Change in Each of the Participant Assessments of Tolerability-Itching
Hide Description This was a tolerability variable, where the participants were instructed to individually assess the right and the left side of the face to indicate the severity that they had experienced during the time period from their last visit for itching. The area on the face was assessed excluding nose, nasogenian, and superior and inferior eyelids. The assessment of the itching was graded on 0 to 5 scale based on severity by the participant; 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wks 1,2,4 and 8) minus the value at BL respectively.
Time Frame BL (Day 1) to Wks 1, 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants available at the specified time points we re analyze d (represented by n=x, x in the category titles).
Arm/Group Title MAXCLARITY II PROACTIV
Hide Arm/Group Description:
MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on scale
Itching; Change from BL to Wk 1 Number Analyzed 20 participants 20 participants
0.20  (0.62) 0.20  (0.77)
Itching; Change from BL to Wk 2 Number Analyzed 19 participants 19 participants
0.37  (1.01) 0.05  (0.62)
Itching; Change from BL to Wk 4 Number Analyzed 18 participants 18 participants
0.33  (0.97) 0.06  (0.24)
Itching; Change from BL to Wk 8 Number Analyzed 18 participants 18 participants
0.28  (0.57) 0.11  (0.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in Itching for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method [Signed Rank]
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 0.00
Parameter Dispersion
Type: Standard Deviation
Value: 0.46
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in Itching for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0625
Comments [Not Specified]
Method Signed Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.32
Parameter Dispersion
Type: Standard Deviation
Value: 0.58
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in Itching for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2500
Comments [Not Specified]
Method Signed Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.28
Parameter Dispersion
Type: Standard Deviation
Value: 0.75
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in Itching for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2500
Comments [Not Specified]
Method Signed Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.17
Parameter Dispersion
Type: Standard Deviation
Value: 0.38
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Mean Change in Each of the Participant Assessments of Tolerability-Scaling
Hide Description This was a tolerability variable, where the participants were instructed to individually assess the right and the left side of the face to indicate the severity that they had experienced during the time period from their last visit for scaling. The area on the face was assessed excluding nose, nasogenian, and superior and inferior eyelids. The assessment of the scaling was graded on 0 to 5 scale based on severity by the participant; 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wks 1,2,4 and 8) minus the value at BL respectively.
Time Frame BL (Day 1) to Wks 1, 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants available at the specified time points we re analyze d (represented by n=X, X in the category titles).
Arm/Group Title MAXCLARITY II PROACTIV
Hide Arm/Group Description:
MAXCLARITY II (2.5% BPO) foam cleanser and foam treatment, 0.5% salicylic acid toner foam were used in this arm, both morning and evening for 8-Wks. The participants in the morning washed their face with MaxClarity II foam cleanser, on 1 side of the face (side of face, where no proactive cleanser and revitalizing toner were used) . The face was patted dry, post which MaxClarity II foam treatment was applied to the MaxClarity II side of the face. The same was repeated in the evening. This was a split face study.
Proactive renewing cleanser and revitalizing toner and the repairing lotion were used both morning and evening for 8-Wks, for the same participant, from Maxclarity II arm, on the other side. The same participants from the Maxclarity II arm, in the morning washed their face with Proactive renewing cleanser on the other side of the face. The face was patted dry, post which revitalizing toner and then the repairing lotion on the same side cleansed with the proactive cleanser. The same was repeated in the evening. This was a split face study.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on scale
Scaling; Change from BL to Wk 1 Number Analyzed 20 participants 20 participants
0.40  (0.68) 0.25  (0.55)
Scaling; Change from BL to Wk 2 Number Analyzed 19 participants 19 participants
0.26  (0.81) 0.16  (0.69)
Scaling; Change from BL to Wk 4 Number Analyzed 18 participants 18 participants
0.56  (0.86) 0.39  (0.78)
Scaling; Change from BL to Wk 8 Number Analyzed 18 participants 18 participants
0.83  (1.20) 0.67  (1.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in Scaling for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5000
Comments [Not Specified]
Method Signed Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Signed Rank
Estimated Value 0.15
Parameter Dispersion
Type: Standard Deviation
Value: 0.59
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in Scaling for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7500
Comments [Not Specified]
Method Signed Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Signed Rank
Estimated Value 0.11
Parameter Dispersion
Type: Standard Deviation
Value: 0.57
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in Scaling for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4531
Comments [Not Specified]
Method Signed Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.17
Parameter Dispersion
Type: Standard Deviation
Value: 0.62
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MAXCLARITY II, PROACTIV
Comments Change, in Scaling for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6250
Comments [Not Specified]
Method Signed Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.17
Parameter Dispersion
Type: Standard Deviation
Value: 0.86
Estimation Comments [Not Specified]
Time Frame From the informed consent taken to up to 4 months
Adverse Event Reporting Description ITT Population. There were no treatment -related adverse events reported during the study, so the data has been reported as an overall, single arm; as the participants used were the same in each arm
 
Arm/Group Title MAXCLARITY II + PROACTIV
Hide Arm/Group Description This was a split face study, wherein the participants, each morning washed their face with MaxClarity II foam cleanser on 1 side of the face and Proactive renewing cleanser on the other side of the face. The face was patted dry the MaxClarity II foam treatment was applied to the MaxClarity II side of the face and on the proactive side, the participant applied the Revitalizing toner and then the Repairing lotion. The same was repeated in the evening, where the participants washed their face with MaxClarity II foam cleanser on 1 side and Proactiv renewing cleanser on the other side of the face. On the Proactiv side, the participant will apply the Revitalizing toner and then the Repairing lotion.
All-Cause Mortality
MAXCLARITY II + PROACTIV
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
MAXCLARITY II + PROACTIV
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 0%
MAXCLARITY II + PROACTIV
Affected / at Risk (%)
Total   5/20 (25.00%) 
Infections and infestations   
Nasopharyngitis  1  3/20 (15.00%) 
Skin infection  1  1/20 (5.00%) 
Nervous system disorders   
Headache  1  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Oropharyngeal pain  1  1/20 (5.00%) 
1
Term from vocabulary, MedDRA 11.1
Indicates events were collected by systematic assessment
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: NCT01706250     History of Changes
Other Study ID Numbers: 114550
First Submitted: October 11, 2012
First Posted: October 15, 2012
Results First Submitted: April 4, 2017
Results First Posted: June 20, 2017
Last Update Posted: August 23, 2017