Trial Outcomes & Findings for Adapalene 0.3% - Benzoyl Peroxide 2.5% Gel and Risk of Formation of Atrophic Acne Scars (NCT NCT02735421)
NCT ID: NCT02735421
Last Updated: 2022-09-14
Results Overview
The scars were counted according to their size defined in two categories using 2-millimeter (mm) and 4-mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars greater than (\>) 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. To obtain the total number of atrophic scars per half-face, atrophic acne scar counts for each half-face was added.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
67 participants
Primary outcome timeframe
Week 24
Results posted on
2022-09-14
Participant Flow
The study was conducted at 6 centers in Canada and France between 13 May 2016 and 23 November 2017. This study was conducted in 2 parts: Part 1 (Randomized) and Part 2 (Open Label).
A total of 67 participants were randomized. All eligible participants had each half-face randomized to one of the two following treatments (with the other treatment applied to the other side of the face): ABPO forte gel and ABPO forte vehicle gel.
Participant milestones
| Measure |
All Participants
Participants applied once-daily adapalene 0.3% - benzoyl peroxide (BPO) 2.5% (ABPO Forte) gel on half-face and ABPO Forte vehicle gel on the other side of the face based on randomization (right or left side of the face) at night for 24 weeks were enrolled in Part 1 of the study. Thereafter, at the decision of the investigator, based on participant's medical assessment of efficacy during Part I, the participants who agreed to continue treatment with ABPO Forte gel for up to 24 additional weeks on the whole face were enrolled in Part 2 of the study.
|
|---|---|
|
Part A (Randomized): up to 24 Weeks
STARTED
|
67
|
|
Part A (Randomized): up to 24 Weeks
COMPLETED
|
54
|
|
Part A (Randomized): up to 24 Weeks
NOT COMPLETED
|
13
|
|
Part 2 (Open Label): up to 48 Weeks
STARTED
|
45
|
|
Part 2 (Open Label): up to 48 Weeks
COMPLETED
|
41
|
|
Part 2 (Open Label): up to 48 Weeks
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
All Participants
Participants applied once-daily adapalene 0.3% - benzoyl peroxide (BPO) 2.5% (ABPO Forte) gel on half-face and ABPO Forte vehicle gel on the other side of the face based on randomization (right or left side of the face) at night for 24 weeks were enrolled in Part 1 of the study. Thereafter, at the decision of the investigator, based on participant's medical assessment of efficacy during Part I, the participants who agreed to continue treatment with ABPO Forte gel for up to 24 additional weeks on the whole face were enrolled in Part 2 of the study.
|
|---|---|
|
Part A (Randomized): up to 24 Weeks
Adverse Event
|
2
|
|
Part A (Randomized): up to 24 Weeks
Withdrawal by Subject
|
6
|
|
Part A (Randomized): up to 24 Weeks
Lost to Follow-up
|
3
|
|
Part A (Randomized): up to 24 Weeks
Inadequate compliance to treatment
|
1
|
|
Part A (Randomized): up to 24 Weeks
Pregnancy
|
1
|
|
Part 2 (Open Label): up to 48 Weeks
Withdrawal by Subject
|
1
|
|
Part 2 (Open Label): up to 48 Weeks
Lost to Follow-up
|
3
|
Baseline Characteristics
Adapalene 0.3% - Benzoyl Peroxide 2.5% Gel and Risk of Formation of Atrophic Acne Scars
Baseline characteristics by cohort
| Measure |
All Participants
n=67 Participants
Participants applied once-daily adapalene 0.3% - benzoyl peroxide (BPO) 2.5% (ABPO Forte) gel on half-face and ABPO Forte vehicle gel on the other side of the face based on randomization (right or left side of the face) at night for 24 weeks were enrolled in Part 1 of the study. Thereafter, at the decision of the investigator, based on participant's medical assessment of efficacy during Part I, the participants who agreed to continue treatment with ABPO Forte gel for up to 24 additional weeks on the whole face were enrolled in Part 2 of the study.
|
|---|---|
|
Age, Categorical
<=18 years
|
19 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
21.5 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
48 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
19 Participants
n=5 Participants
|
|
Skin Phototype
Phototype I
|
3 Participants
n=5 Participants
|
|
Skin Phototype
Phototype II
|
32 Participants
n=5 Participants
|
|
Skin Phototype
Phototype III
|
23 Participants
n=5 Participants
|
|
Skin Phototype
Phototype IV
|
9 Participants
n=5 Participants
|
|
Acne Duration
|
6.8 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: The Intent-to-Treat efficacy population (ITT) included entire population enrolled and randomized.
The scars were counted according to their size defined in two categories using 2-millimeter (mm) and 4-mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars greater than (\>) 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. To obtain the total number of atrophic scars per half-face, atrophic acne scar counts for each half-face was added.
Outcome measures
| Measure |
Part 2: ABPO Forte Vehicle Gel
Participants applied once-daily ABPO Forte vehicle gel on whole face for 48 weeks.
|
Part 1: ABPO Forte Gel
n=67 Participants
Participants applied once-daily ABPO Forte gel on half-face based on randomization (right or left side of the face) at night for 24 weeks.
|
Part 1: ABPO Forte Vehicle Gel
n=67 Participants
Participants applied once-daily ABPO Forte vehicle gel on half-face based on randomization (right or left side of the face) at night for 24 weeks.
|
Part 2: ABPO Forte Gel
Participants applied once-daily ABPO Forte gel on whole face for 48 weeks.
|
|---|---|---|---|---|
|
Part 1: Total Atrophic Acne Scar Count Per Half-face
|
—
|
9.5 atrophic acne scars
Standard Deviation 5.5
|
13.3 atrophic acne scars
Standard Deviation 7.4
|
—
|
SECONDARY outcome
Timeframe: Part 1: Weeks 1, 4, 8, 12, 16 and 20; Part 2: Weeks 1, 4, 8, 12, 16, 20, 36 and 48Population: ITT population included entire population enrolled and randomized. Here, "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.
The scars were counted according to their size defined in two categories using 2 mm and 4 mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars \> 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. To obtain the total number of atrophic scars per half-face, atrophic acne scar counts for each half-face was added.
Outcome measures
| Measure |
Part 2: ABPO Forte Vehicle Gel
n=45 Participants
Participants applied once-daily ABPO Forte vehicle gel on whole face for 48 weeks.
|
Part 1: ABPO Forte Gel
n=67 Participants
Participants applied once-daily ABPO Forte gel on half-face based on randomization (right or left side of the face) at night for 24 weeks.
|
Part 1: ABPO Forte Vehicle Gel
n=67 Participants
Participants applied once-daily ABPO Forte vehicle gel on half-face based on randomization (right or left side of the face) at night for 24 weeks.
|
Part 2: ABPO Forte Gel
n=45 Participants
Participants applied once-daily ABPO Forte gel on whole face for 48 weeks.
|
|---|---|---|---|---|
|
Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit
Week 1
|
13.1 atrophic acne scars
Standard Deviation 6.5
|
11.7 atrophic acne scars
Standard Deviation 6.5
|
12.8 atrophic acne scars
Standard Deviation 6.8
|
12.2 atrophic acne scars
Standard Deviation 6.6
|
|
Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit
Week 4
|
14.2 atrophic acne scars
Standard Deviation 8.1
|
11.9 atrophic acne scars
Standard Deviation 6.8
|
13.6 atrophic acne scars
Standard Deviation 8.0
|
12.2 atrophic acne scars
Standard Deviation 6.8
|
|
Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit
Week 8
|
14.0 atrophic acne scars
Standard Deviation 7.8
|
11.3 atrophic acne scars
Standard Deviation 6.7
|
13.5 atrophic acne scars
Standard Deviation 7.6
|
11.8 atrophic acne scars
Standard Deviation 7.3
|
|
Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit
Week 12
|
14.4 atrophic acne scars
Standard Deviation 8.1
|
10.7 atrophic acne scars
Standard Deviation 6.1
|
13.8 atrophic acne scars
Standard Deviation 7.7
|
11.3 atrophic acne scars
Standard Deviation 6.8
|
|
Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit
Week 16
|
14.2 atrophic acne scars
Standard Deviation 7.6
|
10.7 atrophic acne scars
Standard Deviation 6.2
|
13.7 atrophic acne scars
Standard Deviation 7.2
|
11.0 atrophic acne scars
Standard Deviation 6.8
|
|
Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit
Week 20
|
13.9 atrophic acne scars
Standard Deviation 8.1
|
10.3 atrophic acne scars
Standard Deviation 5.9
|
13.4 atrophic acne scars
Standard Deviation 7.5
|
10.4 atrophic acne scars
Standard Deviation 6.5
|
|
Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit
Week 36
|
11.7 atrophic acne scars
Standard Deviation 7.0
|
—
|
—
|
8.8 atrophic acne scars
Standard Deviation 5.3
|
|
Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit
Week 48
|
9.9 atrophic acne scars
Standard Deviation 6.3
|
—
|
—
|
8.4 atrophic acne scars
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48Population: ITT population included entire population enrolled and randomized. Here, "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.
The scars were counted according to their size defined in two categories using 2 mm and 4 mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars \> 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin.
Outcome measures
| Measure |
Part 2: ABPO Forte Vehicle Gel
n=45 Participants
Participants applied once-daily ABPO Forte vehicle gel on whole face for 48 weeks.
|
Part 1: ABPO Forte Gel
n=67 Participants
Participants applied once-daily ABPO Forte gel on half-face based on randomization (right or left side of the face) at night for 24 weeks.
|
Part 1: ABPO Forte Vehicle Gel
n=67 Participants
Participants applied once-daily ABPO Forte vehicle gel on half-face based on randomization (right or left side of the face) at night for 24 weeks.
|
Part 2: ABPO Forte Gel
n=45 Participants
Participants applied once-daily ABPO Forte gel on whole face for 48 weeks.
|
|---|---|---|---|---|
|
Part 1 and Part 2: Percent Change From Baseline in Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit
Week 1
|
6.6 percent change
Standard Deviation 22.3
|
-2.5 percent change
Standard Deviation 12.5
|
5.8 percent change
Standard Deviation 19.5
|
-2.6 percent change
Standard Deviation 14.2
|
|
Part 1 and Part 2: Percent Change From Baseline in Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit
Week 4
|
12.5 percent change
Standard Deviation 31.1
|
-1.0 percent change
Standard Deviation 21.9
|
9.8 percent change
Standard Deviation 28.1
|
-0.3 percent change
Standard Deviation 25.6
|
|
Part 1 and Part 2: Percent Change From Baseline in Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit
Week 8
|
13.0 percent change
Standard Deviation 35.8
|
-4.5 percent change
Standard Deviation 27.4
|
12.3 percent change
Standard Deviation 32.5
|
-3.6 percent change
Standard Deviation 32.0
|
|
Part 1 and Part 2: Percent Change From Baseline in Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit
Week 12
|
18.1 percent change
Standard Deviation 46.4
|
-7.3 percent change
Standard Deviation 32.9
|
16.2 percent change
Standard Deviation 40.7
|
-7.1 percent change
Standard Deviation 37.3
|
|
Part 1 and Part 2: Percent Change From Baseline in Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit
Week 16
|
18.3 percent change
Standard Deviation 52.2
|
-7.0 percent change
Standard Deviation 35.9
|
17.1 percent change
Standard Deviation 45.6
|
-8.4 percent change
Standard Deviation 40.7
|
|
Part 1 and Part 2: Percent Change From Baseline in Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit
Week 20
|
14.6 percent change
Standard Deviation 58.5
|
-8.7 percent change
Standard Deviation 39.2
|
15.2 percent change
Standard Deviation 51.7
|
-11.7 percent change
Standard Deviation 44.9
|
|
Part 1 and Part 2: Percent Change From Baseline in Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit
Week 24
|
16.7 percent change
Standard Deviation 62.7
|
-15.5 percent change
Standard Deviation 38.9
|
14.4 percent change
Standard Deviation 53.0
|
-21.7 percent change
Standard Deviation 42.8
|
|
Part 1 and Part 2: Percent Change From Baseline in Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit
Week 36
|
-1.8 percent change
Standard Deviation 52.4
|
—
|
—
|
-25.0 percent change
Standard Deviation 37.1
|
|
Part 1 and Part 2: Percent Change From Baseline in Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit
Week 48
|
-15.2 percent change
Standard Deviation 49.6
|
—
|
—
|
-26.9 percent change
Standard Deviation 39.7
|
SECONDARY outcome
Timeframe: Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48Population: ITT population included entire population enrolled and randomized. Here, "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.
ISGA was an assessment scale used to evaluate facial acne severity. ISGA was recorded using a 5-point scale ranges from 0 to 4, where (0 = clear \[No visible scars from acne); 1 = almost clear \[Hardly visible scars from 50 cm away\]; 2 = mild \[Easily recognizable; less than half the affected face area\]; 3 = moderate \[More than half and less than 75% of the affected face area\]; 4 = severe \[More than 75% of the affected face area\]) based on inflammation, pustules and papulation/infiltration. Higher score indicated severe acne.
Outcome measures
| Measure |
Part 2: ABPO Forte Vehicle Gel
n=45 Participants
Participants applied once-daily ABPO Forte vehicle gel on whole face for 48 weeks.
|
Part 1: ABPO Forte Gel
n=67 Participants
Participants applied once-daily ABPO Forte gel on half-face based on randomization (right or left side of the face) at night for 24 weeks.
|
Part 1: ABPO Forte Vehicle Gel
n=67 Participants
Participants applied once-daily ABPO Forte vehicle gel on half-face based on randomization (right or left side of the face) at night for 24 weeks.
|
Part 2: ABPO Forte Gel
n=45 Participants
Participants applied once-daily ABPO Forte gel on whole face for 48 weeks.
|
|---|---|---|---|---|
|
Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score
Week 1
|
2.3 score on a scale
Standard Deviation 0.7
|
2.3 score on a scale
Standard Deviation 0.6
|
2.3 score on a scale
Standard Deviation 0.6
|
2.3 score on a scale
Standard Deviation 0.7
|
|
Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score
Week 4
|
2.2 score on a scale
Standard Deviation 0.8
|
2.2 score on a scale
Standard Deviation 0.6
|
2.3 score on a scale
Standard Deviation 0.7
|
2.2 score on a scale
Standard Deviation 0.7
|
|
Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score
Week 8
|
2.3 score on a scale
Standard Deviation 0.7
|
2.2 score on a scale
Standard Deviation 0.6
|
2.3 score on a scale
Standard Deviation 0.7
|
2.2 score on a scale
Standard Deviation 0.7
|
|
Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score
Week 12
|
2.2 score on a scale
Standard Deviation 0.6
|
2.0 score on a scale
Standard Deviation 0.7
|
2.2 score on a scale
Standard Deviation 0.6
|
1.9 score on a scale
Standard Deviation 0.7
|
|
Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score
Week 16
|
2.1 score on a scale
Standard Deviation 0.6
|
2.0 score on a scale
Standard Deviation 0.7
|
2.2 score on a scale
Standard Deviation 0.6
|
1.9 score on a scale
Standard Deviation 0.7
|
|
Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score
Week 20
|
2.0 score on a scale
Standard Deviation 0.8
|
1.9 score on a scale
Standard Deviation 0.7
|
2.1 score on a scale
Standard Deviation 0.7
|
1.8 score on a scale
Standard Deviation 0.8
|
|
Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score
Week 24
|
2.0 score on a scale
Standard Deviation 0.8
|
1.8 score on a scale
Standard Deviation 0.8
|
2.1 score on a scale
Standard Deviation 0.7
|
1.6 score on a scale
Standard Deviation 0.8
|
|
Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score
Week 36
|
1.8 score on a scale
Standard Deviation 0.6
|
—
|
—
|
1.5 score on a scale
Standard Deviation 0.7
|
|
Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score
Week 48
|
1.5 score on a scale
Standard Deviation 0.7
|
—
|
—
|
1.4 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: At Week 12 and Week 24Population: ITT population included entire population enrolled and randomized. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" signifies those participants who were evaluable for this outcome measure at the specified time point.
The investigator rated their preference on a scale ranging from -2 (left side a lot better than right) to 2 (right side a lot better than left). Overall scar severity was assessed using a 5-point scale where (-2 = Left a lot better than right; -1 = Left a little bit better than right; 0 = No preference; 1 = Right a little bit better than left; 2 = Right a lot better than left. ABPO forte was applied on left side and vehicle gel was applied on right side.
Outcome measures
| Measure |
Part 2: ABPO Forte Vehicle Gel
Participants applied once-daily ABPO Forte vehicle gel on whole face for 48 weeks.
|
Part 1: ABPO Forte Gel
n=63 Participants
Participants applied once-daily ABPO Forte gel on half-face based on randomization (right or left side of the face) at night for 24 weeks.
|
Part 1: ABPO Forte Vehicle Gel
Participants applied once-daily ABPO Forte vehicle gel on half-face based on randomization (right or left side of the face) at night for 24 weeks.
|
Part 2: ABPO Forte Gel
Participants applied once-daily ABPO Forte gel on whole face for 48 weeks.
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants With Investigator's Preference on Overall Scar Severity
Week 12: ABPO Forte a lot better than Vehicle
|
—
|
5.1 percentage of participants
|
—
|
—
|
|
Part 1: Percentage of Participants With Investigator's Preference on Overall Scar Severity
Week 12: ABPO Forte a little bit better than Vehicle
|
—
|
33.9 percentage of participants
|
—
|
—
|
|
Part 1: Percentage of Participants With Investigator's Preference on Overall Scar Severity
Week 24: ABPO Forte a lot better than Vehicle
|
—
|
17.5 percentage of participants
|
—
|
—
|
|
Part 1: Percentage of Participants With Investigator's Preference on Overall Scar Severity
Week 24: ABPO Forte a little bit better than Vehicle
|
—
|
36.5 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1: Weeks 1, 4, 8, 12, 16 and 20; Part 2: Weeks 1, 4, 8, 12, 16, 20, 36 and 48Population: ITT population included entire population enrolled and randomized. Here, "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.
Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and other lesions. The investigator counted all inflammatory lesions (papules and pustules), non-inflammatory lesions (open and closed comedone) and other lesions (nodules) for each half-face.
Outcome measures
| Measure |
Part 2: ABPO Forte Vehicle Gel
n=45 Participants
Participants applied once-daily ABPO Forte vehicle gel on whole face for 48 weeks.
|
Part 1: ABPO Forte Gel
n=67 Participants
Participants applied once-daily ABPO Forte gel on half-face based on randomization (right or left side of the face) at night for 24 weeks.
|
Part 1: ABPO Forte Vehicle Gel
n=67 Participants
Participants applied once-daily ABPO Forte vehicle gel on half-face based on randomization (right or left side of the face) at night for 24 weeks.
|
Part 2: ABPO Forte Gel
n=45 Participants
Participants applied once-daily ABPO Forte gel on whole face for 48 weeks.
|
|---|---|---|---|---|
|
Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit
Week 1
|
-7.6 percent change
Standard Deviation 19.7
|
-20.9 percent change
Standard Deviation 22.1
|
-5.7 percent change
Standard Deviation 19.9
|
-23.4 percent change
Standard Deviation 22.4
|
|
Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit
Week 4
|
-15.2 percent change
Standard Deviation 29.3
|
-34.1 percent change
Standard Deviation 27.4
|
-13.1 percent change
Standard Deviation 29.1
|
-38.6 percent change
Standard Deviation 24.4
|
|
Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit
Week 8
|
-30.4 percent change
Standard Deviation 28.9
|
-45.7 percent change
Standard Deviation 29.3
|
-25.3 percent change
Standard Deviation 31.4
|
-53.6 percent change
Standard Deviation 23.2
|
|
Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit
Week 12
|
-38.7 percent change
Standard Deviation 31.7
|
-54.5 percent change
Standard Deviation 27.9
|
-32.9 percent change
Standard Deviation 32.7
|
-63.3 percent change
Standard Deviation 21.6
|
|
Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit
Week 16
|
-43.3 percent change
Standard Deviation 36.2
|
-60.4 percent change
Standard Deviation 28.5
|
-35.4 percent change
Standard Deviation 35.9
|
-71.9 percent change
Standard Deviation 19.2
|
|
Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit
Week 20
|
-53.2 percent change
Standard Deviation 29.0
|
-63.7 percent change
Standard Deviation 28.0
|
-43.2 percent change
Standard Deviation 33.5
|
-75.0 percent change
Standard Deviation 16.4
|
|
Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit
Week 24
|
-56.4 percent change
Standard Deviation 29.4
|
-66.7 percent change
Standard Deviation 29.1
|
-45.8 percent change
Standard Deviation 33.6
|
-79.4 percent change
Standard Deviation 16.1
|
|
Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit
Week 36
|
-69.9 percent change
Standard Deviation 23.8
|
—
|
—
|
-74.0 percent change
Standard Deviation 19.2
|
|
Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit
Week 48
|
-70.4 percent change
Standard Deviation 23.1
|
—
|
—
|
-72.7 percent change
Standard Deviation 22.8
|
SECONDARY outcome
Timeframe: Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48Population: ITT population included entire population enrolled and randomized. Here, "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.
Inflammatory lesions included papules and pustules. Papule is a small, solid elevation less than one centimeter in diameter. Most of the lesion is above the surface of the skin. Pustule is a small, circumscribed elevation of the skin which contains yellow-white exudates.
Outcome measures
| Measure |
Part 2: ABPO Forte Vehicle Gel
n=45 Participants
Participants applied once-daily ABPO Forte vehicle gel on whole face for 48 weeks.
|
Part 1: ABPO Forte Gel
n=67 Participants
Participants applied once-daily ABPO Forte gel on half-face based on randomization (right or left side of the face) at night for 24 weeks.
|
Part 1: ABPO Forte Vehicle Gel
n=67 Participants
Participants applied once-daily ABPO Forte vehicle gel on half-face based on randomization (right or left side of the face) at night for 24 weeks.
|
Part 2: ABPO Forte Gel
n=45 Participants
Participants applied once-daily ABPO Forte gel on whole face for 48 weeks.
|
|---|---|---|---|---|
|
Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit
Week 1
|
-11.9 percent change
Standard Deviation 26.7
|
-28.0 percent change
Standard Deviation 33.0
|
-10.4 percent change
Standard Deviation 24.8
|
-29.2 percent change
Standard Deviation 34.4
|
|
Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit
Week 4
|
-19.6 percent change
Standard Deviation 39.2
|
-43.5 percent change
Standard Deviation 30.8
|
-19.8 percent change
Standard Deviation 36.7
|
-50.1 percent change
Standard Deviation 24.4
|
|
Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit
Week 8
|
-36.7 percent change
Standard Deviation 32.5
|
-55.1 percent change
Standard Deviation 35.0
|
-31.2 percent change
Standard Deviation 34.7
|
-67.9 percent change
Standard Deviation 17.4
|
|
Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit
Week 12
|
-47.8 percent change
Standard Deviation 32.4
|
-63.6 percent change
Standard Deviation 33.0
|
-39.1 percent change
Standard Deviation 37.9
|
-74.9 percent change
Standard Deviation 21.2
|
|
Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit
Week 16
|
-51.3 percent change
Standard Deviation 35.6
|
-70.1 percent change
Standard Deviation 29.6
|
-39.4 percent change
Standard Deviation 39.6
|
-82.6 percent change
Standard Deviation 14.6
|
|
Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit
Week 20
|
-60.2 percent change
Standard Deviation 27.5
|
-72.6 percent change
Standard Deviation 30.7
|
-47.5 percent change
Standard Deviation 37.5
|
-84.6 percent change
Standard Deviation 17.4
|
|
Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit
Week 24
|
-64.0 percent change
Standard Deviation 23.2
|
-75.4 percent change
Standard Deviation 29.8
|
-50.2 percent change
Standard Deviation 36.3
|
-88.5 percent change
Standard Deviation 11.1
|
|
Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit
Week 36
|
-75.5 percent change
Standard Deviation 25.5
|
—
|
—
|
-81.3 percent change
Standard Deviation 20.5
|
|
Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit
Week 48
|
-73.3 percent change
Standard Deviation 25.7
|
—
|
—
|
-77.2 percent change
Standard Deviation 27.1
|
SECONDARY outcome
Timeframe: Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48Population: ITT population included entire population enrolled and randomized. Here, "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.
Non-inflammatory lesions included open comedone and closed comedone. Open comedone is a mass of sebaceous material that is impacted behind an open follicular orifice (blackhead). Closed comedone is a mass of sebaceous material that is impacted behind a closed follicular orifice (white head).
Outcome measures
| Measure |
Part 2: ABPO Forte Vehicle Gel
n=45 Participants
Participants applied once-daily ABPO Forte vehicle gel on whole face for 48 weeks.
|
Part 1: ABPO Forte Gel
n=67 Participants
Participants applied once-daily ABPO Forte gel on half-face based on randomization (right or left side of the face) at night for 24 weeks.
|
Part 1: ABPO Forte Vehicle Gel
n=67 Participants
Participants applied once-daily ABPO Forte vehicle gel on half-face based on randomization (right or left side of the face) at night for 24 weeks.
|
Part 2: ABPO Forte Gel
n=45 Participants
Participants applied once-daily ABPO Forte gel on whole face for 48 weeks.
|
|---|---|---|---|---|
|
Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit
Week 1
|
-2.7 percent change
Standard Deviation 33.6
|
-9.2 percent change
Standard Deviation 29.2
|
0.3 percent change
Standard Deviation 30.8
|
-10.7 percent change
Standard Deviation 33.1
|
|
Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit
Week 4
|
-4.7 percent change
Standard Deviation 39.1
|
-20.1 percent change
Standard Deviation 36.1
|
-1.5 percent change
Standard Deviation 36.8
|
-22.8 percent change
Standard Deviation 39.4
|
|
Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit
Week 8
|
-21.7 percent change
Standard Deviation 44.8
|
-32.4 percent change
Standard Deviation 34.7
|
-16.0 percent change
Standard Deviation 42.7
|
-36.5 percent change
Standard Deviation 36.4
|
|
Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit
Week 12
|
-24.4 percent change
Standard Deviation 40.7
|
-40.8 percent change
Standard Deviation 31.3
|
-21.1 percent change
Standard Deviation 37.9
|
-47.8 percent change
Standard Deviation 29.9
|
|
Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit
Week 16
|
-29.7 percent change
Standard Deviation 43.8
|
-47.7 percent change
Standard Deviation 34.1
|
-24.7 percent change
Standard Deviation 40.8
|
-58.9 percent change
Standard Deviation 30.1
|
|
Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit
Week 20
|
-41.7 percent change
Standard Deviation 39.9
|
-51.4 percent change
Standard Deviation 33.1
|
-33.3 percent change
Standard Deviation 39.9
|
-62.4 percent change
Standard Deviation 27.6
|
|
Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit
Week 24
|
-44.6 percent change
Standard Deviation 41.0
|
-55.4 percent change
Standard Deviation 34.7
|
-35.6 percent change
Standard Deviation 40.5
|
-67.9 percent change
Standard Deviation 28.2
|
|
Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit
Week 36
|
-59.6 percent change
Standard Deviation 30.8
|
—
|
—
|
-64.5 percent change
Standard Deviation 28.6
|
|
Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit
Week 48
|
-62.5 percent change
Standard Deviation 28.4
|
—
|
—
|
-64.9 percent change
Standard Deviation 27.6
|
SECONDARY outcome
Timeframe: Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48Population: ITT population included entire population enrolled and randomized. Here, "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.
IGA is an assessment scale used to determine severity of acne and clinical response to treatment on a 5-point scale (0 = clear \[Clear skin with no inflammatory or non inflammatory lesions\]; 1= almost clear \[A few scattered comedones and a few small papules\]; 2= mild \[Easily recognizable; less than half the face is involved. Some comedones and some papules and pustules\]; 3= moderate \[More than half of the face is involved. Many comedones, papules and pustules. One small nodule may be present\] and 4= severe \[Entire face is involved. Covered with comedones, numerous papules and pustules. Few nodules may or may not be present\]) based on erythema and papulation/ infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear).
Outcome measures
| Measure |
Part 2: ABPO Forte Vehicle Gel
n=45 Participants
Participants applied once-daily ABPO Forte vehicle gel on whole face for 48 weeks.
|
Part 1: ABPO Forte Gel
n=67 Participants
Participants applied once-daily ABPO Forte gel on half-face based on randomization (right or left side of the face) at night for 24 weeks.
|
Part 1: ABPO Forte Vehicle Gel
n=67 Participants
Participants applied once-daily ABPO Forte vehicle gel on half-face based on randomization (right or left side of the face) at night for 24 weeks.
|
Part 2: ABPO Forte Gel
n=45 Participants
Participants applied once-daily ABPO Forte gel on whole face for 48 weeks.
|
|---|---|---|---|---|
|
Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit
Week 1
|
3.0 score on a scale
Standard Deviation 0.4
|
2.7 score on a scale
Standard Deviation 0.6
|
3.0 score on a scale
Standard Deviation 0.4
|
2.7 score on a scale
Standard Deviation 0.6
|
|
Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit
Week 4
|
2.8 score on a scale
Standard Deviation 0.6
|
2.5 score on a scale
Standard Deviation 0.7
|
2.8 score on a scale
Standard Deviation 0.6
|
2.5 score on a scale
Standard Deviation 0.7
|
|
Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit
Week 8
|
2.6 score on a scale
Standard Deviation 0.6
|
2.3 score on a scale
Standard Deviation 0.7
|
2.7 score on a scale
Standard Deviation 0.6
|
2.1 score on a scale
Standard Deviation 0.8
|
|
Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit
Week 12
|
2.2 score on a scale
Standard Deviation 0.7
|
1.9 score on a scale
Standard Deviation 0.8
|
2.4 score on a scale
Standard Deviation 0.7
|
1.7 score on a scale
Standard Deviation 0.7
|
|
Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit
Week 16
|
2.0 score on a scale
Standard Deviation 0.9
|
1.6 score on a scale
Standard Deviation 0.8
|
2.2 score on a scale
Standard Deviation 0.8
|
1.2 score on a scale
Standard Deviation 0.5
|
|
Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit
Week 20
|
1.9 score on a scale
Standard Deviation 0.8
|
1.5 score on a scale
Standard Deviation 0.9
|
2.1 score on a scale
Standard Deviation 0.8
|
1.1 score on a scale
Standard Deviation 0.6
|
|
Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit
Week 24
|
1.9 score on a scale
Standard Deviation 0.8
|
1.4 score on a scale
Standard Deviation 0.9
|
2.2 score on a scale
Standard Deviation 0.8
|
1.0 score on a scale
Standard Deviation 0.5
|
|
Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit
Week 36
|
1.4 score on a scale
Standard Deviation 0.7
|
—
|
—
|
1.2 score on a scale
Standard Deviation 0.6
|
|
Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit
Week 48
|
1.3 score on a scale
Standard Deviation 0.7
|
—
|
—
|
1.2 score on a scale
Standard Deviation 0.7
|
Adverse Events
Part 1: ABPO Forte Gel
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Part 1: ABPO Forte Vehicle Gel
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2: ABPO Forte Gel
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Part 2: ABPO Forte Vehicle Gel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1: ABPO Forte Gel
n=67 participants at risk
Participants applied once-daily ABPO Forte gel on half-face based on randomization (right or left side of the face) at night for 24 weeks.
|
Part 1: ABPO Forte Vehicle Gel
n=67 participants at risk
Participants applied once-daily ABPO Forte vehicle gel on half-face based on randomization (right or left side of the face) at night for 24 weeks.
|
Part 2: ABPO Forte Gel
n=45 participants at risk
Participants applied once-daily ABPO Forte gel on whole face for 48 weeks.
|
Part 2: ABPO Forte Vehicle Gel
n=45 participants at risk
Participants applied once-daily ABPO Forte vehicle gel on whole face for 48 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/67 • Part 1: up to 24 weeks; Part 2: up to 48 weeks
The safety population included all randomized participants, after exclusion of participants who never took the treatment with certainty based on monitoring report.
|
0.00%
0/67 • Part 1: up to 24 weeks; Part 2: up to 48 weeks
The safety population included all randomized participants, after exclusion of participants who never took the treatment with certainty based on monitoring report.
|
13.3%
6/45 • Part 1: up to 24 weeks; Part 2: up to 48 weeks
The safety population included all randomized participants, after exclusion of participants who never took the treatment with certainty based on monitoring report.
|
0.00%
0/45 • Part 1: up to 24 weeks; Part 2: up to 48 weeks
The safety population included all randomized participants, after exclusion of participants who never took the treatment with certainty based on monitoring report.
|
|
Nervous system disorders
Headache
|
0.00%
0/67 • Part 1: up to 24 weeks; Part 2: up to 48 weeks
The safety population included all randomized participants, after exclusion of participants who never took the treatment with certainty based on monitoring report.
|
0.00%
0/67 • Part 1: up to 24 weeks; Part 2: up to 48 weeks
The safety population included all randomized participants, after exclusion of participants who never took the treatment with certainty based on monitoring report.
|
11.1%
5/45 • Part 1: up to 24 weeks; Part 2: up to 48 weeks
The safety population included all randomized participants, after exclusion of participants who never took the treatment with certainty based on monitoring report.
|
0.00%
0/45 • Part 1: up to 24 weeks; Part 2: up to 48 weeks
The safety population included all randomized participants, after exclusion of participants who never took the treatment with certainty based on monitoring report.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
16.4%
11/67 • Number of events 11 • Part 1: up to 24 weeks; Part 2: up to 48 weeks
The safety population included all randomized participants, after exclusion of participants who never took the treatment with certainty based on monitoring report.
|
7.5%
5/67 • Number of events 5 • Part 1: up to 24 weeks; Part 2: up to 48 weeks
The safety population included all randomized participants, after exclusion of participants who never took the treatment with certainty based on monitoring report.
|
6.7%
3/45 • Part 1: up to 24 weeks; Part 2: up to 48 weeks
The safety population included all randomized participants, after exclusion of participants who never took the treatment with certainty based on monitoring report.
|
0.00%
0/45 • Part 1: up to 24 weeks; Part 2: up to 48 weeks
The safety population included all randomized participants, after exclusion of participants who never took the treatment with certainty based on monitoring report.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER