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U0289-402: An Open Label, 8 Week Study to Evaluate the Efficacy and Tolerability of MAXCLARITY II in Subjects With Acne

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ClinicalTrials.gov Identifier: NCT01706263
Recruitment Status : Completed
First Posted : October 15, 2012
Results First Posted : January 8, 2018
Last Update Posted : January 8, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: MAXCLARITY II (2.5% BPO) Foam Cleanser
Drug: MAXCLARITY II (2.5% BPO) Foam Treatment
Drug: MAXCLARITY II (0.5% Salicylic Acid) Toner Foam
Enrollment 28
Recruitment Details Male or female participants aged from 18 to 29 years with mild facial acne vulgaris were enrolled in this study. The study was conducted at three different study centers. Study period was 8 Weeks (56 days) and study conducted from 19 August 2009 to 01 December 2009.
Pre-assignment Details  
Arm/Group Title MAXCLARITY II
Hide Arm/Group Description The eligible participants applied a small amount of the MAXCLARITY II™ 2.5 percent (%) benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
Period Title: Overall Study
Started 28
Completed 28
Not Completed 0
Arm/Group Title MAXCLARITY II
Hide Arm/Group Description The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants
21.7  (4.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
18
  64.3%
Male
10
  35.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   3.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
7
  25.0%
White
20
  71.4%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Week 8
Time Frame Baseline (Day 1) and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis set was used which included data from all randomized participants who received study product.
Arm/Group Title MAXCLARITY II
Hide Arm/Group Description:
The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: Percent change
Inflammatory lesion count -62.1  (37.1)
Non-Inflammatory lesion count -49.8  (39.7)
Total lesion count -56.9  (32.7)
2.Secondary Outcome
Title Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Weeks 1, 2, and 4
Time Frame Baseline (Day 1) and Week 1, 2, 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis set.
Arm/Group Title MAXCLARITY II
Hide Arm/Group Description:
The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: Percent change
Inflammatory lesion count, Week 1 -27.9  (29.8)
Inflammatory lesion count, Week 2 -50.8  (25.6)
Inflammatory lesion count, Week 4 -49.5  (30.6)
Non-Inflammatory lesion count, Week 1 -9.9  (45.1)
Non-Inflammatory lesion count, Week 2 -23.4  (38.0)
Non-Inflammatory lesion count, Week 4 -34.3  (37.5)
Total lesion count, Week 1 -22.6  (27.6)
Total lesion count, Week 2 -37.8  (24.1)
Total lesion count, Week 4 -44.9  (28.5)
3.Secondary Outcome
Title Mean Change in Investigator's Static Global Assessment (ISGA) From Baseline to Weeks 1, 2, 4 and 8
Hide Description Evaluator assessed the acne severity of participants' faces using the ISGA scale on a five point scale which ranged from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value .
Time Frame Baseline (Day 1) and Week 1, 2, 4, 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis set.
Arm/Group Title MAXCLARITY II
Hide Arm/Group Description:
The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: Score on a scale
ISGA score, Week 1 -0.07  (0.54)
ISGA score, Week 2 -0.46  (0.58)
ISGA score, Week 4 -0.39  (0.69)
ISGA score, Week 8 -0.61  (0.69)
4.Secondary Outcome
Title Percentage of Participants Who Improved by at Least One Grade on the ISGA
Hide Description Evaluator assessed the acne severity of participants' faces using the ISGA scale on a five point scale which ranged from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Percent change from Baseline to specified time point was calculated as the value at specified time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value .
Time Frame Up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis set.
Arm/Group Title MAXCLARITY II
Hide Arm/Group Description:
The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule..
Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: Percentage of participants
Atleast one grade improvement,Week 1 17.9
Atleast two grade improvement,Week 1 0.0
Atleast one grade improvement,Week 2 42.9
Atleast two grade improvement,Week 2 3.6
Atleast one grade improvement,Week 4 35.7
Atleast two grade improvement,Week 4 7.1
Atleast one grade improvement,Week 8 50.0
Atleast two grade improvement,Week 8 10.7
5.Secondary Outcome
Title Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
Hide Description Erythema , dryness, and peeling, were evaluated independently by the investigator on a five point scale ranged from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value .
Time Frame Baseline (Day 1) and Week 1, 2, 4, 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis set.
Arm/Group Title MAXCLARITY II
Hide Arm/Group Description:
The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: Score on scale
Erythema, Week 1 0.00  (0.38)
Erythema, Week 2 -0.04  (0.43)
Erythema, Week 4 -0.04  (0.79)
Erythema, Week 8 -0.32  (0.55)
Dryness, Week 1 0.14  (0.45)
Dryness, Week 2 0.32  (0.61)
Dryness, Week 4 0.11  (0.42)
Dryness, Week 8 0.11  (0.31)
Peeling, Week 1 0.11  (0.42)
Peeling, Week 2 0.21  (0.50)
Peeling, Week 4 0.04  (0.19)
Peeling, Week 8 0.11  (0.31)
6.Secondary Outcome
Title Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8
Hide Description Redness, dryness, burning, itching and scaling were evaluated independently by the participant on a five point scale ranged from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value .
Time Frame Baseline (Day 1) and Week 1, 2, 4, 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis set.
Arm/Group Title MAXCLARITY II
Hide Arm/Group Description:
The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: Score on scale
Redness,Week 1 -0.39  (1.03)
Redness,Week 2 -0.25  (1.24)
Redness,Week 4 -0.18  (1.09)
Redness,Week 8 -0.36  (1.34)
Dryness,Week 1 0.04  (1.20)
Dryness,Week 2 0.07  (1.30)
Dryness,Week 4 0.00  (1.09)
Dryness,Week 8 0.11  (1.40)
Burning,Week 1 0.21  (1.10)
Burning,Week 2 0.36  (1.22)
Burning,Week 4 0.32  (0.67)
Burning,Week 8 -0.07  (1.02)
Itching,Week 1 0.07  (0.90)
Itching,Week 2 0.07  (1.02)
Itching,Week 4 0.14  (1.15)
Itching,Week 8 0.07  (0.94)
Scaling,Week 1 -0.14  (0.71)
Scaling,Week 2 -0.11  (1.13)
Scaling,Week 4 -0.04  (0.74)
Scaling,Week 8 -0.18  (1.12)
Time Frame Adverse events and serious adverse events were reported throughout the study (from Baseline Up to Week 8)
Adverse Event Reporting Description Intent-to-treat analysis set was used to report adverse events.
 
Arm/Group Title MAXCLARITY II
Hide Arm/Group Description The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.
All-Cause Mortality
MAXCLARITY II
Affected / at Risk (%)
Total   0/28 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
MAXCLARITY II
Affected / at Risk (%)
Total   0/28 (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
Affected / at Risk (%)
Total   11/28 (39.29%) 
Gastrointestinal disorders   
Hiatus hernia  1  1/28 (3.57%) 
General disorders   
Application Site Burning  1  1/28 (3.57%) 
Infections and infestations   
Bronchitis  1  2/28 (7.14%) 
Influenza  1  3/28 (10.71%) 
Nasopharyngitis  1  5/28 (17.86%) 
Pneumonia  1  1/28 (3.57%) 
Sinusitis  1  1/28 (3.57%) 
Injury, poisoning and procedural complications   
Skin Laceration  1  1/28 (3.57%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/28 (3.57%) 
Respiratory, thoracic and mediastinal disorders   
Oropharyngeal Pain  1  1/28 (3.57%) 
Skin and subcutaneous tissue disorders   
Ecchymosis  1  1/28 (3.57%) 
1
Term from vocabulary, MedDRA 12.1
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: NCT01706263     History of Changes
Other Study ID Numbers: 114551
First Submitted: October 11, 2012
First Posted: October 15, 2012
Results First Submitted: July 18, 2017
Results First Posted: January 8, 2018
Last Update Posted: January 8, 2018