Trial Outcomes & Findings for 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 (NCT NCT01446237)
NCT ID: NCT01446237
Last Updated: 2017-05-25
Results Overview
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.
COMPLETED
NA
125 participants
Baseline (Day 1) and Week 1, 2, 4, 8, 12
2017-05-25
Participant Flow
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.
Participant milestones
| Measure |
MaxClarity
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.
|
|---|---|
|
Overall Study
STARTED
|
125
|
|
Overall Study
COMPLETED
|
115
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
MaxClarity
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.
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|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
7
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
MaxClarity
n=125 Participants
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.
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|---|---|
|
Age, Continuous
|
19.0 Years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
84 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native/Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native/Black
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Biracial
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 1, 2, 4, 8, 12Population: 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.
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.
Outcome measures
| Measure |
MaxClarity
n=125 Participants
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.
|
|---|---|
|
Mean Percent Changes in Inflammatory (IL), Non-inflammatory (NIL), and Total Lesion (TL) Counts From Baseline to Each Study Visit
IL Week 1
|
-30.4 Percent change in lesions
Standard Deviation 25.8
|
|
Mean Percent Changes in Inflammatory (IL), Non-inflammatory (NIL), and Total Lesion (TL) Counts From Baseline to Each Study Visit
IL Week 2
|
-44.8 Percent change in lesions
Standard Deviation 26.4
|
|
Mean Percent Changes in Inflammatory (IL), Non-inflammatory (NIL), and Total Lesion (TL) Counts From Baseline to Each Study Visit
IL Week 4
|
-52.9 Percent change in lesions
Standard Deviation 27.0
|
|
Mean Percent Changes in Inflammatory (IL), Non-inflammatory (NIL), and Total Lesion (TL) Counts From Baseline to Each Study Visit
IL Week 8
|
-59.8 Percent change in lesions
Standard Deviation 23.7
|
|
Mean Percent Changes in Inflammatory (IL), Non-inflammatory (NIL), and Total Lesion (TL) Counts From Baseline to Each Study Visit
IL Week 12
|
-67.1 Percent change in lesions
Standard Deviation 22.7
|
|
Mean Percent Changes in Inflammatory (IL), Non-inflammatory (NIL), and Total Lesion (TL) Counts From Baseline to Each Study Visit
NIL Week 1
|
-14.8 Percent change in lesions
Standard Deviation 24.4
|
|
Mean Percent Changes in Inflammatory (IL), Non-inflammatory (NIL), and Total Lesion (TL) Counts From Baseline to Each Study Visit
NIL Week 2
|
-28.5 Percent change in lesions
Standard Deviation 24.4
|
|
Mean Percent Changes in Inflammatory (IL), Non-inflammatory (NIL), and Total Lesion (TL) Counts From Baseline to Each Study Visit
NIL Week 4
|
-37.1 Percent change in lesions
Standard Deviation 30.1
|
|
Mean Percent Changes in Inflammatory (IL), Non-inflammatory (NIL), and Total Lesion (TL) Counts From Baseline to Each Study Visit
NIL Week 8
|
-43.8 Percent change in lesions
Standard Deviation 29.3
|
|
Mean Percent Changes in Inflammatory (IL), Non-inflammatory (NIL), and Total Lesion (TL) Counts From Baseline to Each Study Visit
NIL Week 12
|
-57.3 Percent change in lesions
Standard Deviation 25.8
|
|
Mean Percent Changes in Inflammatory (IL), Non-inflammatory (NIL), and Total Lesion (TL) Counts From Baseline to Each Study Visit
TL Week 1
|
-22.2 Percent change in lesions
Standard Deviation 20.6
|
|
Mean Percent Changes in Inflammatory (IL), Non-inflammatory (NIL), and Total Lesion (TL) Counts From Baseline to Each Study Visit
TL Week 2
|
-36.0 Percent change in lesions
Standard Deviation 21.5
|
|
Mean Percent Changes in Inflammatory (IL), Non-inflammatory (NIL), and Total Lesion (TL) Counts From Baseline to Each Study Visit
TL Week 4
|
-44.4 Percent change in lesions
Standard Deviation 23.6
|
|
Mean Percent Changes in Inflammatory (IL), Non-inflammatory (NIL), and Total Lesion (TL) Counts From Baseline to Each Study Visit
TL Week 8
|
-51.0 Percent change in lesions
Standard Deviation 23.2
|
|
Mean Percent Changes in Inflammatory (IL), Non-inflammatory (NIL), and Total Lesion (TL) Counts From Baseline to Each Study Visit
TL Week 12
|
-61.6 Percent change in lesions
Standard Deviation 22.0
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 1, 2, 4, 8, 12Population: ITT population. Only those participants with data available at that particular time points were analyzed.
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.
Outcome measures
| Measure |
MaxClarity
n=125 Participants
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.
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|---|---|
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Number of Participants With a Minimum 2-grade Improvement of Investigator's Static Global Assessment (ISGA) From Baseline to Each Study Visit
Week 1
|
3 Participants
|
|
Number of Participants With a Minimum 2-grade Improvement of Investigator's Static Global Assessment (ISGA) From Baseline to Each Study Visit
Week 2
|
6 Participants
|
|
Number of Participants With a Minimum 2-grade Improvement of Investigator's Static Global Assessment (ISGA) From Baseline to Each Study Visit
Week 4
|
12 Participants
|
|
Number of Participants With a Minimum 2-grade Improvement of Investigator's Static Global Assessment (ISGA) From Baseline to Each Study Visit
Week 8
|
19 Participants
|
|
Number of Participants With a Minimum 2-grade Improvement of Investigator's Static Global Assessment (ISGA) From Baseline to Each Study Visit
Week 12
|
31 Participants
|
PRIMARY outcome
Timeframe: Week 1, 2, 4, 8 and 12Population: ITT population.
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).
Outcome measures
| Measure |
MaxClarity
n=125 Participants
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.
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|---|---|
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Number of Participants With ISGA Score of 0 (Clear) or 1 (Almost Clear) at Each Study Visit
Week 1
|
1 Participants
|
|
Number of Participants With ISGA Score of 0 (Clear) or 1 (Almost Clear) at Each Study Visit
Week 2
|
2 Participants
|
|
Number of Participants With ISGA Score of 0 (Clear) or 1 (Almost Clear) at Each Study Visit
Week 4
|
4 Participants
|
|
Number of Participants With ISGA Score of 0 (Clear) or 1 (Almost Clear) at Each Study Visit
Week 8
|
10 Participants
|
|
Number of Participants With ISGA Score of 0 (Clear) or 1 (Almost Clear) at Each Study Visit
Week 12
|
20 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 1, 2, 4, 8, 12Population: ITT population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in category titles).
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.
Outcome measures
| Measure |
MaxClarity
n=125 Participants
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.
|
|---|---|
|
Absolute Change in IL, NIL, and TL Count From Baseline to Each Study Visit
IL Week 1
|
-9.6 Lesions
Standard Deviation 8.2
|
|
Absolute Change in IL, NIL, and TL Count From Baseline to Each Study Visit
IL Week 2
|
-14.3 Lesions
Standard Deviation 8.9
|
|
Absolute Change in IL, NIL, and TL Count From Baseline to Each Study Visit
IL Week 4
|
-16.9 Lesions
Standard Deviation 9.3
|
|
Absolute Change in IL, NIL, and TL Count From Baseline to Each Study Visit
IL Week 8
|
-18.9 Lesions
Standard Deviation 8.0
|
|
Absolute Change in IL, NIL, and TL Count From Baseline to Each Study Visit
IL Week 12
|
-21.4 Lesions
Standard Deviation 8.2
|
|
Absolute Change in IL, NIL, and TL Count From Baseline to Each Study Visit
NIL Week 1
|
-7.4 Lesions
Standard Deviation 12.1
|
|
Absolute Change in IL, NIL, and TL Count From Baseline to Each Study Visit
NIL Week 2
|
-13.4 Lesions
Standard Deviation 13.5
|
|
Absolute Change in IL, NIL, and TL Count From Baseline to Each Study Visit
NIL Week 4
|
-17.6 Lesions
Standard Deviation 15.4
|
|
Absolute Change in IL, NIL, and TL Count From Baseline to Each Study Visit
NIL Week 8
|
-20.1 Lesions
Standard Deviation 16.3
|
|
Absolute Change in IL, NIL, and TL Count From Baseline to Each Study Visit
NIL Week 12
|
-25.6 Lesions
Standard Deviation 15.3
|
|
Absolute Change in IL, NIL, and TL Count From Baseline to Each Study Visit
TL Week 1
|
-17.0 Lesions
Standard Deviation 16.6
|
|
Absolute Change in IL, NIL, and TL Count From Baseline to Each Study Visit
TL Week 2
|
-27.7 Lesions
Standard Deviation 18.8
|
|
Absolute Change in IL, NIL, and TL Count From Baseline to Each Study Visit
TL Week 4
|
-34.5 Lesions
Standard Deviation 20.3
|
|
Absolute Change in IL, NIL, and TL Count From Baseline to Each Study Visit
TL Week 8
|
-38.9 Lesions
Standard Deviation 20.4
|
|
Absolute Change in IL, NIL, and TL Count From Baseline to Each Study Visit
TL Week 12
|
-47.0 Lesions
Standard Deviation 19.8
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 1, 2, 4, 8, 12Population: ITT population. Only those participants with data available at the indicated time points were analyzed.
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.
Outcome measures
| Measure |
MaxClarity
n=125 Participants
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.
|
|---|---|
|
Mean Change in ISGA From Baseline to Each Study Visit
Week 4
|
-0.63 Scores on a scale
Standard Deviation 0.69
|
|
Mean Change in ISGA From Baseline to Each Study Visit
Week 8
|
-0.79 Scores on a scale
Standard Deviation 0.75
|
|
Mean Change in ISGA From Baseline to Each Study Visit
Week 12
|
-1.05 Scores on a scale
Standard Deviation 0.78
|
|
Mean Change in ISGA From Baseline to Each Study Visit
Week 1
|
-0.29 Scores on a scale
Standard Deviation 0.51
|
|
Mean Change in ISGA From Baseline to Each Study Visit
Week 2
|
-0.45 Scores on a scale
Standard Deviation 0.61
|
Adverse Events
MaxClarity
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MaxClarity
n=125 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.80%
1/125 • Adverse events (AEs) and serious adverse events (SAEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
ITT population was used for all analyses which comprised of all participants enrolled in the study.
|
|
Immune system disorders
SEASONAL ALLERGY
|
0.80%
1/125 • Adverse events (AEs) and serious adverse events (SAEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
ITT population was used for all analyses which comprised of all participants enrolled in the study.
|
|
Infections and infestations
NASOPHARYNGITIS
|
2.4%
3/125 • Adverse events (AEs) and serious adverse events (SAEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
ITT population was used for all analyses which comprised of all participants enrolled in the study.
|
|
Infections and infestations
ORAL HERPES
|
1.6%
2/125 • Adverse events (AEs) and serious adverse events (SAEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
ITT population was used for all analyses which comprised of all participants enrolled in the study.
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
0.80%
1/125 • Adverse events (AEs) and serious adverse events (SAEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
ITT population was used for all analyses which comprised of all participants enrolled in the study.
|
|
Infections and infestations
POST PROCEDURAL INFECTION
|
0.80%
1/125 • Adverse events (AEs) and serious adverse events (SAEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
ITT population was used for all analyses which comprised of all participants enrolled in the study.
|
|
Infections and infestations
SINUSITIS
|
0.80%
1/125 • Adverse events (AEs) and serious adverse events (SAEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
ITT population was used for all analyses which comprised of all participants enrolled in the study.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.80%
1/125 • Adverse events (AEs) and serious adverse events (SAEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
ITT population was used for all analyses which comprised of all participants enrolled in the study.
|
|
Infections and infestations
VULVOVAGINAL MYCOTIC INFECTION
|
0.80%
1/125 • Adverse events (AEs) and serious adverse events (SAEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
ITT population was used for all analyses which comprised of all participants enrolled in the study.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.80%
1/125 • Adverse events (AEs) and serious adverse events (SAEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
ITT population was used for all analyses which comprised of all participants enrolled in the study.
|
|
Nervous system disorders
BURNING SENSATION
|
0.80%
1/125 • Adverse events (AEs) and serious adverse events (SAEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
ITT population was used for all analyses which comprised of all participants enrolled in the study.
|
|
Reproductive system and breast disorders
OVARIAN CYST
|
0.80%
1/125 • Adverse events (AEs) and serious adverse events (SAEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
ITT population was used for all analyses which comprised of all participants enrolled in the study.
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
0.80%
1/125 • Adverse events (AEs) and serious adverse events (SAEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
ITT population was used for all analyses which comprised of all participants enrolled in the study.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.80%
1/125 • Adverse events (AEs) and serious adverse events (SAEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
ITT population was used for all analyses which comprised of all participants enrolled in the study.
|
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