Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

U0289-405: An Open-Label, 12-Week Study to Evaluate the Efficacy and Safety of the Acne System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%) in Subjects With Acne

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01446237
Recruitment Status : Completed
First Posted : October 5, 2011
Results First Posted : April 18, 2017
Last Update Posted : May 25, 2017
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
Intervention Other: acne system - benzoyl peroxide 2.5%, Salicyclic Acid 0.5%
Enrollment 125
Recruitment Details A total of 125 participants of 12 to 35 years from 9 centers in the United States were enrolled in this 12 Week study to evaluate the efficacy and safety of the MaxClarity System in participants with acne. The study started on 23 June 2011 and completed on 14 December 2011.
Pre-assignment Details  
Arm/Group Title MaxClarity
Hide Arm/Group Description Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (Benzoyl Peroxide[BPO]) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 percent salicylic acid [SA]) each evening over an application period of 12 weeks.
Period Title: Overall Study
Started 125
Completed 115
Not Completed 10
Reason Not Completed
Adverse Event             1
Lost to Follow-up             2
Withdrawal by Subject             7
Arm/Group Title MaxClarity
Hide Arm/Group Description Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
Overall Number of Baseline Participants 125
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 125 participants
19.0  (5.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants
Female
68
  54.4%
Male
57
  45.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 125 participants
American Indian or Alaskan Native 7
Asian 9
Black 21
Native Hawaiian or Other Pacific Islander 1
White 84
American Indian or Alaska Native/Asian 1
American Indian or Alaska Native/Black 1
Biracial 1
1.Primary Outcome
Title Mean Percent Changes in Inflammatory (IL), Non-inflammatory (NIL), and Total Lesion (TL) Counts From Baseline to Each Study Visit
Hide Description The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by lesion counts- IL (papules and pustules), NIL (open and closed comedones), and TL. The area considered for efficacy assessments was confined to the face. The area of the face to be examined extended from the hairline to the mandible; includes the forehead, cheeks, and chin; and excludes the mouth, nasal region, periocular area, and superior and inferior eyelids. Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value. Mean percent change from baseline at each study visit was presented.
Time Frame Baseline (Day 1) and Week 1, 2, 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population consisted of all participants that were enrolled in the study. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title MaxClarity
Hide Arm/Group Description:
Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
Overall Number of Participants Analyzed 125
Mean (Standard Deviation)
Unit of Measure: Percent change in lesions
IL Week 1 Number Analyzed 120 participants
-30.4  (25.8)
IL Week 2 Number Analyzed 121 participants
-44.8  (26.4)
IL Week 4 Number Analyzed 120 participants
-52.9  (27.0)
IL Week 8 Number Analyzed 116 participants
-59.8  (23.7)
IL Week 12 Number Analyzed 122 participants
-67.1  (22.7)
NIL Week 1 Number Analyzed 120 participants
-14.8  (24.4)
NIL Week 2 Number Analyzed 121 participants
-28.5  (24.4)
NIL Week 4 Number Analyzed 120 participants
-37.1  (30.1)
NIL Week 8 Number Analyzed 116 participants
-43.8  (29.3)
NIL Week 12 Number Analyzed 122 participants
-57.3  (25.8)
TL Week 1 Number Analyzed 120 participants
-22.2  (20.6)
TL Week 2 Number Analyzed 121 participants
-36.0  (21.5)
TL Week 4 Number Analyzed 120 participants
-44.4  (23.6)
TL Week 8 Number Analyzed 116 participants
-51.0  (23.2)
TL Week 12 Number Analyzed 122 participants
-61.6  (22.0)
2.Primary Outcome
Title Number of Participants With a Minimum 2-grade Improvement of Investigator’s Static Global Assessment (ISGA) From Baseline to Each Study Visit
Hide Description The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions). Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value.
Time Frame Baseline (Day 1) and Week 1, 2, 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants with data available at that particular time points were analyzed.
Arm/Group Title MaxClarity
Hide Arm/Group Description:
Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
Overall Number of Participants Analyzed 125
Measure Type: Number
Unit of Measure: Participants
Week 1 Number Analyzed 120 participants
3
Week 2 Number Analyzed 121 participants
6
Week 4 Number Analyzed 120 participants
12
Week 8 Number Analyzed 116 participants
19
Week 12 Number Analyzed 122 participants
31
3.Primary Outcome
Title Number of Participants With ISGA Score of 0 (Clear) or 1 (Almost Clear) at Each Study Visit
Hide Description The investigator assessed efficacy at baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions).
Time Frame Week 1, 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title MaxClarity
Hide Arm/Group Description:
Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
Overall Number of Participants Analyzed 125
Measure Type: Number
Unit of Measure: Participants
Week 1 1
Week 2 2
Week 4 4
Week 8 10
Week 12 20
4.Secondary Outcome
Title Absolute Change in IL, NIL, and TL Count From Baseline to Each Study Visit
Hide Description The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by lesion counts- IL (papules and pustules), NIL (open and closed comedones), and TL. The area considered for efficacy assessments was confined to the face. The area of the face to be examined extends from the hairline to the mandible; includes the forehead, cheeks, and chin; and excludes the mouth, nasal region, periocular area, and superior and inferior eyelids. Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value.
Time Frame Baseline (Day 1) and Week 1, 2, 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in category titles).
Arm/Group Title MaxClarity
Hide Arm/Group Description:
Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
Overall Number of Participants Analyzed 125
Mean (Standard Deviation)
Unit of Measure: Lesions
IL Week 1 Number Analyzed 120 participants
-9.6  (8.2)
IL Week 2 Number Analyzed 121 participants
-14.3  (8.9)
IL Week 4 Number Analyzed 120 participants
-16.9  (9.3)
IL Week 8 Number Analyzed 116 participants
-18.9  (8.0)
IL Week 12 Number Analyzed 122 participants
-21.4  (8.2)
NIL Week 1 Number Analyzed 120 participants
-7.4  (12.1)
NIL Week 2 Number Analyzed 121 participants
-13.4  (13.5)
NIL Week 4 Number Analyzed 120 participants
-17.6  (15.4)
NIL Week 8 Number Analyzed 116 participants
-20.1  (16.3)
NIL Week 12 Number Analyzed 122 participants
-25.6  (15.3)
TL Week 1 Number Analyzed 120 participants
-17.0  (16.6)
TL Week 2 Number Analyzed 121 participants
-27.7  (18.8)
TL Week 4 Number Analyzed 120 participants
-34.5  (20.3)
TL Week 8 Number Analyzed 116 participants
-38.9  (20.4)
TL Week 12 Number Analyzed 122 participants
-47.0  (19.8)
5.Secondary Outcome
Title Mean Change in ISGA From Baseline to Each Study Visit
Hide Description The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions). Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value.
Time Frame Baseline (Day 1) and Week 1, 2, 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title MaxClarity
Hide Arm/Group Description:
Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
Overall Number of Participants Analyzed 125
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Week 1 Number Analyzed 120 participants
-0.29  (0.51)
Week 2 Number Analyzed 121 participants
-0.45  (0.61)
Week 4 Number Analyzed 120 participants
-0.63  (0.69)
Week 8 Number Analyzed 116 participants
-0.79  (0.75)
Week 12 Number Analyzed 122 participants
-1.05  (0.78)
Time Frame Adverse events (AEs) and serious adverse events (SAEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
Adverse Event Reporting Description ITT population was used for all analyses which comprised of all participants enrolled in the study.
 
Arm/Group Title MaxClarity
Hide Arm/Group Description Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
All-Cause Mortality
MaxClarity
Affected / at Risk (%)
Total   0/125 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
MaxClarity
Affected / at Risk (%)
Total   0/125 (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
Affected / at Risk (%)
Total   12/125 (9.60%) 
Gastrointestinal disorders   
GASTROOESOPHAGEAL REFLUX DISEASE  1  1/125 (0.80%) 
Immune system disorders   
SEASONAL ALLERGY  1  1/125 (0.80%) 
Infections and infestations   
NASOPHARYNGITIS  1  3/125 (2.40%) 
ORAL HERPES  1  2/125 (1.60%) 
PHARYNGITIS STREPTOCOCCAL  1  1/125 (0.80%) 
POST PROCEDURAL INFECTION  1  1/125 (0.80%) 
SINUSITIS  1  1/125 (0.80%) 
UPPER RESPIRATORY TRACT INFECTION  1  1/125 (0.80%) 
VULVOVAGINAL MYCOTIC INFECTION  1  1/125 (0.80%) 
Injury, poisoning and procedural complications   
CONTUSION  1  1/125 (0.80%) 
Nervous system disorders   
BURNING SENSATION  1  1/125 (0.80%) 
Reproductive system and breast disorders   
OVARIAN CYST  1  1/125 (0.80%) 
Respiratory, thoracic and mediastinal disorders   
RHINITIS ALLERGIC  1  1/125 (0.80%) 
Skin and subcutaneous tissue disorders   
RASH  1  1/125 (0.80%) 
1
Term from vocabulary, MedDRA 14.1
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
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT01446237     History of Changes
Other Study ID Numbers: 115576
First Submitted: July 28, 2011
First Posted: October 5, 2011
Results First Submitted: March 6, 2017
Results First Posted: April 18, 2017
Last Update Posted: May 25, 2017