Trial Outcomes & Findings for U0289-401: Eight Week, Split-face, Study to Determine and Compare the Efficacy and Tolerability of MAXCLARITY™ II to PROACTIV™ (NCT NCT01706250)
NCT ID: NCT01706250
Last Updated: 2017-08-23
Results Overview
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.
COMPLETED
PHASE4
20 participants
BL (Day 1) and Wk 8
2017-08-23
Participant Flow
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.
Same 20 participants were used in the split face study for the 2 interventions namely MaxClarity and Proactiv carried out in a single period.
Participant milestones
| Measure |
MAXCLARITY II + PROACTIV
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 Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
MAXCLARITY II + PROACTIV
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 Study
Lost to Follow-up
|
2
|
Baseline Characteristics
U0289-401: Eight Week, Split-face, Study to Determine and Compare the Efficacy and Tolerability of MAXCLARITY™ II to PROACTIV™
Baseline characteristics by cohort
| Measure |
MAXCLARITY II + PROACTIV
n=20 Participants
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.
|
|---|---|
|
Age, Continuous
|
21.5 Years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BL (Day 1) and Wk 8Population: 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.
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.
Outcome measures
| Measure |
MAXCLARITY II
n=18 Participants
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.
|
PROACTIV
n=18 Participants
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.
|
|---|---|---|
|
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.
Percent change, IL count
|
-55.93 percent change in lesion count
Standard Deviation 32.72
|
-52.64 percent change in lesion count
Standard Deviation 29.23
|
|
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.
Percent change, NIL count
|
-37.97 percent change in lesion count
Standard Deviation 38.72
|
-45.66 percent change in lesion count
Standard Deviation 23.05
|
|
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.
Percent change in TL count
|
-45.46 percent change in lesion count
Standard Deviation 27.24
|
-47.69 percent change in lesion count
Standard Deviation 21.92
|
SECONDARY outcome
Timeframe: BL (Day1) to Wks 1, 2 and 4Population: ITT used. Only those participants available at the specified time points were analyzed (re presented by n=x, x in the category titles).
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.
Outcome measures
| Measure |
MAXCLARITY II
n=20 Participants
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.
|
PROACTIV
n=20 Participants
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.
|
|---|---|---|
|
Mean Percent Change in IL Count From BL (Day 1) to Wks 1, 2 and 4
Percent change, IL count, BL to Wk 1
|
-17.56 percent change in lesion count
Standard Deviation 33.63
|
-19.93 percent change in lesion count
Standard Deviation 26.39
|
|
Mean Percent Change in IL Count From BL (Day 1) to Wks 1, 2 and 4
Percent change, IL count, BL to Wk 2
|
-35.64 percent change in lesion count
Standard Deviation 37.66
|
-31.64 percent change in lesion count
Standard Deviation 30.06
|
|
Mean Percent Change in IL Count From BL (Day 1) to Wks 1, 2 and 4
Percent change, IL count, BL to Wk 4
|
-21.35 percent change in lesion count
Standard Deviation 63.62
|
-44.99 percent change in lesion count
Standard Deviation 37.85
|
SECONDARY outcome
Timeframe: BL (Day 1) to Wks 1, 2 and 4Population: ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
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.
Outcome measures
| Measure |
MAXCLARITY II
n=20 Participants
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.
|
PROACTIV
n=20 Participants
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.
|
|---|---|---|
|
Mean Percent Change in NIL Count From BL (Day 1) to Wks 1, 2 and 4
Percent change, NIL count, BL to Wk 1
|
-3.92 percent change in lesion count
Standard Deviation 32.71
|
-7.13 percent change in lesion count
Standard Deviation 25.91
|
|
Mean Percent Change in NIL Count From BL (Day 1) to Wks 1, 2 and 4
Percent change, NIL count, BL to Wk 2
|
-24.12 percent change in lesion count
Standard Deviation 37.73
|
-21.07 percent change in lesion count
Standard Deviation 26.17
|
|
Mean Percent Change in NIL Count From BL (Day 1) to Wks 1, 2 and 4
Percent change, NIL count, BL to Wk 4
|
-30.26 percent change in lesion count
Standard Deviation 38.48
|
-37.76 percent change in lesion count
Standard Deviation 22.65
|
SECONDARY outcome
Timeframe: BL (Day 1) to Wks 1, 2 and 4Population: ITT population. Only those participants available at the specified time points we re analyze d (represented by n=X, X in the category titles).
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.
Outcome measures
| Measure |
MAXCLARITY II
n=20 Participants
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.
|
PROACTIV
n=20 Participants
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.
|
|---|---|---|
|
Mean Percent Change in TL Count From BL (Day 1) to Wks 1, 2 and 4
Percent change, in TL count, BL to Wk 1
|
-11.34 percent change in lesion count
Standard Deviation 21.84
|
-13.36 percent change in lesion count
Standard Deviation 19.07
|
|
Mean Percent Change in TL Count From BL (Day 1) to Wks 1, 2 and 4
Percent change, in TL count, BL to Wk 2
|
-31.94 percent change in lesion count
Standard Deviation 27.86
|
-26.19 percent change in lesion count
Standard Deviation 20.23
|
|
Mean Percent Change in TL Count From BL (Day 1) to Wks 1, 2 and 4
Percent change, in TL count, BL to Wk 4
|
-34.17 percent change in lesion count
Standard Deviation 28.06
|
-41.17 percent change in lesion count
Standard Deviation 20.23
|
SECONDARY outcome
Timeframe: BL (Day 1) to Wks 1, 2, 4 and 8Population: ITT population. Only those participants available at the specified time points we re analyze d (represented by n=x, x in the category titles).
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.
Outcome measures
| Measure |
MAXCLARITY II
n=20 Participants
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.
|
PROACTIV
n=20 Participants
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.
|
|---|---|---|
|
Mean Change in Investigator's Static Global Assessment (ISGA) From BL (Day 1) to Wks 1, 2, 4 and 8.
Change, in ISGA from BL to Wk 4
|
-0.53 units on scale
Standard Deviation 0.51
|
-0.42 units on scale
Standard Deviation 0.61
|
|
Mean Change in Investigator's Static Global Assessment (ISGA) From BL (Day 1) to Wks 1, 2, 4 and 8.
Change, in ISGA from BL to Wk 8
|
-0.39 units on scale
Standard Deviation 0.61
|
-0.39 units on scale
Standard Deviation 0.61
|
|
Mean Change in Investigator's Static Global Assessment (ISGA) From BL (Day 1) to Wks 1, 2, 4 and 8.
Change, in ISGA from BL to Wk 1
|
-0.10 units on scale
Standard Deviation 0.31
|
-0.05 units on scale
Standard Deviation 0.39
|
|
Mean Change in Investigator's Static Global Assessment (ISGA) From BL (Day 1) to Wks 1, 2, 4 and 8.
Change, in ISGA from BL to Wk 2
|
-0.47 units on scale
Standard Deviation 0.61
|
-0.21 units on scale
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: BL (Day 1) to Wks 1, 2, 4 and 8Population: ITT population. Only those participants available at the specified time points we re analyze d (represented by n=X, X in the category titles).
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.
Outcome measures
| Measure |
MAXCLARITY II
n=20 Participants
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.
|
PROACTIV
n=20 Participants
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.
|
|---|---|---|
|
Mean Change in Each of the Evaluator Tolerability Assessments-Erythema
Erythema; Change from BL to Wk 1
|
0.05 units on scale
Standard Deviation 0.51
|
-0.05 units on scale
Standard Deviation 0.22
|
|
Mean Change in Each of the Evaluator Tolerability Assessments-Erythema
Erythema; Change from BL to Wk 2
|
-0.05 units on scale
Standard Deviation 0.23
|
-0.11 units on scale
Standard Deviation 0.32
|
|
Mean Change in Each of the Evaluator Tolerability Assessments-Erythema
Erythema; Change from BL to Wk 4
|
0.05 units on scale
Standard Deviation 0.40
|
0.05 units on scale
Standard Deviation 0.40
|
|
Mean Change in Each of the Evaluator Tolerability Assessments-Erythema
Erythema; Change from BL to Wk 8
|
0.06 units on scale
Standard Deviation 0.42
|
0.06 units on scale
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: BL (Day 1) to Wks 1, 2, 4 and 8Population: ITT population. Only those participants available at the specified time points we re analyze d (represented by n=X, X in the category titles).
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.
Outcome measures
| Measure |
MAXCLARITY II
n=20 Participants
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.
|
PROACTIV
n=20 Participants
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.
|
|---|---|---|
|
Mean Change in Each of the Evaluator Tolerability Assessments-Dryness
Dryness; Change from BL to Wk 1
|
0.15 units on scale
Standard Deviation 0.49
|
0.10 units on scale
Standard Deviation 0.45
|
|
Mean Change in Each of the Evaluator Tolerability Assessments-Dryness
Dryness; Change from BL to Wk 2
|
0.00 units on scale
Standard Deviation 0.00
|
0.00 units on scale
Standard Deviation 0.00
|
|
Mean Change in Each of the Evaluator Tolerability Assessments-Dryness
Dryness; Change from BL to Wk 4
|
0.05 units on scale
Standard Deviation 0.23
|
0.00 units on scale
Standard Deviation 0.00
|
|
Mean Change in Each of the Evaluator Tolerability Assessments-Dryness
Dryness; Change from BL to Wk 8
|
0.11 units on scale
Standard Deviation 0.32
|
0.11 units on scale
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: BL (Day 1) to Wks 1, 2, 4 and 8Population: ITT population. Only those participants available at the specified time points were analyze d (represented by n=x, x in the category titles).
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.
Outcome measures
| Measure |
MAXCLARITY II
n=20 Participants
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.
|
PROACTIV
n=20 Participants
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.
|
|---|---|---|
|
Mean Change in Each of the Evaluator Tolerability Assessments-Peeling
Peeling; Change from BL to Wk 1
|
0.00 units on scale
Standard Deviation 0.00
|
0.00 units on scale
Standard Deviation 0.00
|
|
Mean Change in Each of the Evaluator Tolerability Assessments-Peeling
Peeling; Change from BL to Wk 2
|
0.00 units on scale
Standard Deviation 0.00
|
0.11 units on scale
Standard Deviation 0.46
|
|
Mean Change in Each of the Evaluator Tolerability Assessments-Peeling
Peeling; Change from BL to Wk 4
|
0.00 units on scale
Standard Deviation 0.00
|
0.00 units on scale
Standard Deviation 0.00
|
|
Mean Change in Each of the Evaluator Tolerability Assessments-Peeling
Peeling; Change from BL to Wk 8
|
0.00 units on scale
Standard Deviation 0.00
|
0.00 units on scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: BL (Day 1) to Wks 1, 2, 4 and 8Population: ITT population. Only those participants available at the specified time points we re analyze d (represented by n=x, x in the category titles).
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.
Outcome measures
| Measure |
MAXCLARITY II
n=20 Participants
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.
|
PROACTIV
n=20 Participants
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.
|
|---|---|---|
|
Mean Change in Each of the Participant Tolerability Assessments-Redness
Redness; Change from BL to Wk 1
|
0.50 units on scale
Standard Deviation 1.00
|
0.35 units on scale
Standard Deviation 0.81
|
|
Mean Change in Each of the Participant Tolerability Assessments-Redness
Redness; Change from BL to Wk 2
|
0.37 units on scale
Standard Deviation 1.01
|
0.21 units on scale
Standard Deviation 0.79
|
|
Mean Change in Each of the Participant Tolerability Assessments-Redness
Redness; Change from BL to Wk 4
|
0.72 units on scale
Standard Deviation 1.13
|
0.56 units on scale
Standard Deviation 0.86
|
|
Mean Change in Each of the Participant Tolerability Assessments-Redness
Redness; Change from BL to Wk 8
|
0.61 units on scale
Standard Deviation 1.14
|
0.28 units on scale
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: BL (Day 1) to Wks 1, 2, 4 and 8Population: ITT population . Only those participants available at the specified time points we re analyze d (represented by n=x, x in the category titles).
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.
Outcome measures
| Measure |
MAXCLARITY II
n=20 Participants
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.
|
PROACTIV
n=20 Participants
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.
|
|---|---|---|
|
Mean Change in Each of the Participant Assessments of Tolerability-Dryness
Dryness; Change from BL to Wk 1
|
1.20 units on scale
Standard Deviation 1.24
|
0.90 units on scale
Standard Deviation 1.07
|
|
Mean Change in Each of the Participant Assessments of Tolerability-Dryness
Dryness; Change from BL to Wk 2
|
1.05 units on scale
Standard Deviation 1.39
|
0.68 units on scale
Standard Deviation 1.16
|
|
Mean Change in Each of the Participant Assessments of Tolerability-Dryness
Dryness; Change from BL to Wk 4
|
1.33 units on scale
Standard Deviation 1.14
|
1.06 units on scale
Standard Deviation 1.00
|
|
Mean Change in Each of the Participant Assessments of Tolerability-Dryness
Dryness; Change from BL to Wk 8
|
1.33 units on scale
Standard Deviation 1.24
|
1.11 units on scale
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: BL (Day 1) to Wks 1,2, 4 and 8Population: ITT population. Only those participants available at the specified time points we re analyze d (represented by n=x, x in the category titles).
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.
Outcome measures
| Measure |
MAXCLARITY II
n=20 Participants
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.
|
PROACTIV
n=20 Participants
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.
|
|---|---|---|
|
Mean Change in Each of the Participant Assessments of Tolerability-Burning
Burning; Change from BL to Wk 1
|
0.95 units on scale
Standard Deviation 1.28
|
0.75 units on scale
Standard Deviation 0.85
|
|
Mean Change in Each of the Participant Assessments of Tolerability-Burning
Burning; Change from BL to Wk 2
|
0.84 units on scale
Standard Deviation 1.17
|
0.58 units on scale
Standard Deviation 0.84
|
|
Mean Change in Each of the Participant Assessments of Tolerability-Burning
Burning; Change from BL to Wk 4
|
1.00 units on scale
Standard Deviation 1.08
|
0.44 units on scale
Standard Deviation 0.62
|
|
Mean Change in Each of the Participant Assessments of Tolerability-Burning
Burning; Change from BL to Wk 8
|
0.83 units on scale
Standard Deviation 1.34
|
0.44 units on scale
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: BL (Day 1) to Wks 1, 2, 4 and 8Population: ITT population. Only those participants available at the specified time points we re analyze d (represented by n=x, x in the category titles).
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.
Outcome measures
| Measure |
MAXCLARITY II
n=20 Participants
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.
|
PROACTIV
n=20 Participants
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.
|
|---|---|---|
|
Mean Change in Each of the Participant Assessments of Tolerability-Itching
Itching; Change from BL to Wk 1
|
0.20 units on scale
Standard Deviation 0.62
|
0.20 units on scale
Standard Deviation 0.77
|
|
Mean Change in Each of the Participant Assessments of Tolerability-Itching
Itching; Change from BL to Wk 2
|
0.37 units on scale
Standard Deviation 1.01
|
0.05 units on scale
Standard Deviation 0.62
|
|
Mean Change in Each of the Participant Assessments of Tolerability-Itching
Itching; Change from BL to Wk 4
|
0.33 units on scale
Standard Deviation 0.97
|
0.06 units on scale
Standard Deviation 0.24
|
|
Mean Change in Each of the Participant Assessments of Tolerability-Itching
Itching; Change from BL to Wk 8
|
0.28 units on scale
Standard Deviation 0.57
|
0.11 units on scale
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: BL (Day 1) to Wks 1, 2, 4 and 8Population: ITT population. Only those participants available at the specified time points we re analyze d (represented by n=X, X in the category titles).
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.
Outcome measures
| Measure |
MAXCLARITY II
n=20 Participants
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.
|
PROACTIV
n=20 Participants
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.
|
|---|---|---|
|
Mean Change in Each of the Participant Assessments of Tolerability-Scaling
Scaling; Change from BL to Wk 1
|
0.40 units on scale
Standard Deviation 0.68
|
0.25 units on scale
Standard Deviation 0.55
|
|
Mean Change in Each of the Participant Assessments of Tolerability-Scaling
Scaling; Change from BL to Wk 2
|
0.26 units on scale
Standard Deviation 0.81
|
0.16 units on scale
Standard Deviation 0.69
|
|
Mean Change in Each of the Participant Assessments of Tolerability-Scaling
Scaling; Change from BL to Wk 4
|
0.56 units on scale
Standard Deviation 0.86
|
0.39 units on scale
Standard Deviation 0.78
|
|
Mean Change in Each of the Participant Assessments of Tolerability-Scaling
Scaling; Change from BL to Wk 8
|
0.83 units on scale
Standard Deviation 1.20
|
0.67 units on scale
Standard Deviation 1.14
|
Adverse Events
MAXCLARITY II + PROACTIV
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MAXCLARITY II + PROACTIV
n=20 participants at risk
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.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
15.0%
3/20 • From the informed consent taken to up to 4 months
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
|
|
Infections and infestations
Skin infection
|
5.0%
1/20 • From the informed consent taken to up to 4 months
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
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • From the informed consent taken to up to 4 months
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
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
1/20 • From the informed consent taken to up to 4 months
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
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER