Acne Vulgaris, Atrophic Acne Scars
Conditions
Keywords
acne, scars
Brief summary
This was a multi-centre, randomized, investigator blinded, vehicle controlled trial using intra-individual comparison (right half-face versus left half-face). Participants with each half-face randomized to one of the two following treatments: * Adapalene 0.3 percent (%) - benzoyl peroxide (BPO) 2.5% gel (TactuPump® Forte). * Vehicle gel The main objective of this trial was to evaluate the effect of Adapalene 0.3% - BPO 2.5% (ABPO Forte) gel versus vehicle gel on the risk of formation of atrophic acne scars in moderate to severe acne participants.
Interventions
DRUGABPO Forte Gel
Participants applied Adapalene 0.3% - Benzoyl peroxide (BPO) 2.5% gel (ABPO Forte) topically to the affected areas once daily for 24 weeks in Part 1 and for 48 weeks in Part 2.
DRUGVehicle gel
Participants applied placebo matched to ABPO Forte gel topically to the affected areas once daily for 24 weeks in Part 1 and 48 weeks in Part 2.
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Participants with clinical diagnosis of moderate to severe acne vulgaris on the face defined by: 1. Investigator's Global Assessment score of 3 or 4, with same score on both sides; and 2. A minimum of 25 inflammatory lesions (papules and pustules) in total, with at least 10 on each side (excluding the nose); and 3. No more than two acne nodules (less than or equal to \[\>=\] 1 centimeter \[cm\]); and 4. A minimum of 10 atrophic acne scars in total (upper than 2 millimeters \[mm\]) (excluding the nose) * Participants with a symmetric number of both inflammatory and non-inflammatory lesions on the whole face, and atrophic acne scars on the whole face. * Participants with skin phototype of I to IV on Fitzpatrick's scale. Main
Exclusion criteria
* Participants with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, acne requiring systemic treatment. * Prior failure to treatment with TactuPump® Forte (Adapalene 0.3% - BPO 2.5%). * Participants with more than 3 excoriated acne lesions. * Participants with skin abraded on the treated area or affected by eczema, seborrhoeic dermatitis, cuts or sunburn. * Female participant who is pregnant, nursing or planning a pregnancy during the trial or within one month after the last trial treatment application. * Male participant with a beard or facial hair, which would interfere with the clinical trial evaluations or clinical trial procedures. * Participants having received at least one of the following topical treatments on the treated area: Corticosteroids, antibiotics, benzoyl peroxide, azelaic acid, hydroxyacids, Zinc containing treatments, antibacterials, antiseptics, other anti-inflammatory drugs or other acne treatments (2 weeks); Retinoids (4 weeks); Cosmetic/aesthetic procedures on the face (1 week); Photodynamic therapy, laser therapy, microdermabrasion for acne (3 months). * Participants having received at least one of the following systemic treatments: Corticosteroids (except locally acting corticosteroids such as inhaled or intrathecal or dermal application at distance from the face), antibiotics (except penicillin) (1 month); Spironolactone (3 months) / Drospirenone (3 months, unless dose is stable since at least 3 months); Oral retinoids (6 months); Cyproterone acetate / Chlormadinone acetate (6 months); Immunomodulators (3 months).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Total Atrophic Acne Scar Count Per Half-face | Week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1 and Part 2: Percent Change From Baseline in Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit | Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48 | 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. |
| Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48 | 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. |
| Part 1: Percentage of Participants With Investigator's Preference on Overall Scar Severity | At Week 12 and Week 24 | 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. |
| Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit | Part 1: Weeks 1, 4, 8, 12, 16 and 20; Part 2: Weeks 1, 4, 8, 12, 16, 20, 36 and 48 | 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. |
| Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48 | 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. |
| Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48 | 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). |
| Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit | Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48 | 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). |
| Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit | Part 1: Weeks 1, 4, 8, 12, 16 and 20; Part 2: Weeks 1, 4, 8, 12, 16, 20, 36 and 48 | 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. |
Countries
Canada, France
Participant flow
Recruitment details
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).
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 67 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Part 2 (Open Label): up to 48 Weeks | Lost to Follow-up | 3 |
| Part 2 (Open Label): up to 48 Weeks | Withdrawal by Subject | 1 |
| Part A (Randomized): up to 24 Weeks | Adverse Event | 2 |
| Part A (Randomized): up to 24 Weeks | Inadequate compliance to treatment | 1 |
| Part A (Randomized): up to 24 Weeks | Lost to Follow-up | 3 |
| Part A (Randomized): up to 24 Weeks | Pregnancy | 1 |
| Part A (Randomized): up to 24 Weeks | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Acne Duration | 6.8 years STANDARD_DEVIATION 4.2 |
| Age, Categorical <=18 years | 19 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants |
| Age, Continuous | 21.5 years STANDARD_DEVIATION 4.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 58 Participants |
| Region of Enrollment Canada | 48 Participants |
| Region of Enrollment France | 19 Participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 23 Participants |
| Skin Phototype Phototype I | 3 Participants |
| Skin Phototype Phototype II | 32 Participants |
| Skin Phototype Phototype III | 23 Participants |
| Skin Phototype Phototype IV | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 67 | 0 / 45 | 0 / 45 |
| other Total, other adverse events | 11 / 67 | 5 / 67 | 14 / 45 | 0 / 45 |
| serious Total, serious adverse events | 0 / 67 | 0 / 67 | 0 / 45 | 0 / 45 |
Outcome results
Primary
Part 1: Total Atrophic Acne Scar Count Per Half-face
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.
Time frame: Week 24
Population: The Intent-to-Treat efficacy population (ITT) included entire population enrolled and randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: ABPO Forte Gel | Part 1: Total Atrophic Acne Scar Count Per Half-face | 9.5 atrophic acne scars | Standard Deviation 5.5 |
| Part 1: ABPO Forte Vehicle Gel | Part 1: Total Atrophic Acne Scar Count Per Half-face | 13.3 atrophic acne scars | Standard Deviation 7.4 |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit
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).
Time frame: Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit | Week 12 | 1.9 score on a scale | Standard Deviation 0.8 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit | Week 4 | 2.5 score on a scale | Standard Deviation 0.7 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit | Week 16 | 1.6 score on a scale | Standard Deviation 0.8 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit | Week 8 | 2.3 score on a scale | Standard Deviation 0.7 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit | Week 20 | 1.5 score on a scale | Standard Deviation 0.9 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit | Week 24 | 1.4 score on a scale | Standard Deviation 0.9 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit | Week 1 | 2.7 score on a scale | Standard Deviation 0.6 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit | Week 12 | 2.4 score on a scale | Standard Deviation 0.7 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit | Week 24 | 2.2 score on a scale | Standard Deviation 0.8 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit | Week 20 | 2.1 score on a scale | Standard Deviation 0.8 |
| Part 1: ABPO Forte Vehicle Gel | 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 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit | Week 16 | 2.2 score on a scale | Standard Deviation 0.8 |
| Part 1: ABPO Forte Vehicle Gel | 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 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit | Week 8 | 2.7 score on a scale | Standard Deviation 0.6 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit | Week 8 | 2.1 score on a scale | Standard Deviation 0.8 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit | Week 24 | 1.0 score on a scale | Standard Deviation 0.5 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit | Week 36 | 1.2 score on a scale | Standard Deviation 0.6 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit | Week 48 | 1.2 score on a scale | Standard Deviation 0.7 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit | Week 1 | 2.7 score on a scale | Standard Deviation 0.6 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit | Week 20 | 1.1 score on a scale | Standard Deviation 0.6 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit | Week 4 | 2.5 score on a scale | Standard Deviation 0.7 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit | Week 12 | 1.7 score on a scale | Standard Deviation 0.7 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit | Week 16 | 1.2 score on a scale | Standard Deviation 0.5 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
Secondary
Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score
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.
Time frame: Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 1 | 2.3 score on a scale | Standard Deviation 0.6 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 4 | 2.2 score on a scale | Standard Deviation 0.6 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 8 | 2.2 score on a scale | Standard Deviation 0.6 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 12 | 2.0 score on a scale | Standard Deviation 0.7 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 16 | 2.0 score on a scale | Standard Deviation 0.7 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 20 | 1.9 score on a scale | Standard Deviation 0.7 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 24 | 1.8 score on a scale | Standard Deviation 0.8 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 8 | 2.3 score on a scale | Standard Deviation 0.7 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 16 | 2.2 score on a scale | Standard Deviation 0.6 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 24 | 2.1 score on a scale | Standard Deviation 0.7 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 4 | 2.3 score on a scale | Standard Deviation 0.7 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 1 | 2.3 score on a scale | Standard Deviation 0.6 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 20 | 2.1 score on a scale | Standard Deviation 0.7 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 12 | 2.2 score on a scale | Standard Deviation 0.6 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 36 | 1.5 score on a scale | Standard Deviation 0.7 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 48 | 1.4 score on a scale | Standard Deviation 0.8 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 20 | 1.8 score on a scale | Standard Deviation 0.8 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 12 | 1.9 score on a scale | Standard Deviation 0.7 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 1 | 2.3 score on a scale | Standard Deviation 0.7 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 8 | 2.2 score on a scale | Standard Deviation 0.7 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 24 | 1.6 score on a scale | Standard Deviation 0.8 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 4 | 2.2 score on a scale | Standard Deviation 0.7 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 16 | 1.9 score on a scale | Standard Deviation 0.7 |
| Part 2: ABPO Forte Vehicle Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 16 | 2.1 score on a scale | Standard Deviation 0.6 |
| Part 2: ABPO Forte Vehicle Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 24 | 2.0 score on a scale | Standard Deviation 0.8 |
| Part 2: ABPO Forte Vehicle Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 8 | 2.3 score on a scale | Standard Deviation 0.7 |
| Part 2: ABPO Forte Vehicle Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 12 | 2.2 score on a scale | Standard Deviation 0.6 |
| Part 2: ABPO Forte Vehicle Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 36 | 1.8 score on a scale | Standard Deviation 0.6 |
| Part 2: ABPO Forte Vehicle Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 4 | 2.2 score on a scale | Standard Deviation 0.8 |
| Part 2: ABPO Forte Vehicle Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 20 | 2.0 score on a scale | Standard Deviation 0.8 |
| Part 2: ABPO Forte Vehicle Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 48 | 1.5 score on a scale | Standard Deviation 0.7 |
| Part 2: ABPO Forte Vehicle Gel | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | Week 1 | 2.3 score on a scale | Standard Deviation 0.7 |
Secondary
Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit
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.
Time frame: Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 1 | -28.0 percent change | Standard Deviation 33 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 4 | -43.5 percent change | Standard Deviation 30.8 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 8 | -55.1 percent change | Standard Deviation 35 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 12 | -63.6 percent change | Standard Deviation 33 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 16 | -70.1 percent change | Standard Deviation 29.6 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 20 | -72.6 percent change | Standard Deviation 30.7 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 24 | -75.4 percent change | Standard Deviation 29.8 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 8 | -31.2 percent change | Standard Deviation 34.7 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 16 | -39.4 percent change | Standard Deviation 39.6 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 24 | -50.2 percent change | Standard Deviation 36.3 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 4 | -19.8 percent change | Standard Deviation 36.7 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 1 | -10.4 percent change | Standard Deviation 24.8 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 20 | -47.5 percent change | Standard Deviation 37.5 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 12 | -39.1 percent change | Standard Deviation 37.9 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 36 | -81.3 percent change | Standard Deviation 20.5 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 48 | -77.2 percent change | Standard Deviation 27.1 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 20 | -84.6 percent change | Standard Deviation 17.4 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 12 | -74.9 percent change | Standard Deviation 21.2 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 1 | -29.2 percent change | Standard Deviation 34.4 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 8 | -67.9 percent change | Standard Deviation 17.4 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 24 | -88.5 percent change | Standard Deviation 11.1 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 4 | -50.1 percent change | Standard Deviation 24.4 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 16 | -82.6 percent change | Standard Deviation 14.6 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
Secondary
Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit
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).
Time frame: Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 1 | -9.2 percent change | Standard Deviation 29.2 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 12 | -40.8 percent change | Standard Deviation 31.3 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 8 | -32.4 percent change | Standard Deviation 34.7 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 24 | -55.4 percent change | Standard Deviation 34.7 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 20 | -51.4 percent change | Standard Deviation 33.1 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 16 | -47.7 percent change | Standard Deviation 34.1 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 4 | -20.1 percent change | Standard Deviation 36.1 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 8 | -16.0 percent change | Standard Deviation 42.7 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 1 | 0.3 percent change | Standard Deviation 30.8 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 4 | -1.5 percent change | Standard Deviation 36.8 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 12 | -21.1 percent change | Standard Deviation 37.9 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 16 | -24.7 percent change | Standard Deviation 40.8 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 20 | -33.3 percent change | Standard Deviation 39.9 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 24 | -35.6 percent change | Standard Deviation 40.5 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 12 | -47.8 percent change | Standard Deviation 29.9 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 16 | -58.9 percent change | Standard Deviation 30.1 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 1 | -10.7 percent change | Standard Deviation 33.1 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 48 | -64.9 percent change | Standard Deviation 27.6 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 20 | -62.4 percent change | Standard Deviation 27.6 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 8 | -36.5 percent change | Standard Deviation 36.4 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 24 | -67.9 percent change | Standard Deviation 28.2 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 4 | -22.8 percent change | Standard Deviation 39.4 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Week 36 | -64.5 percent change | Standard Deviation 28.6 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
Secondary
Part 1 and Part 2: Percent Change From Baseline in Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit
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.
Time frame: Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: ABPO Forte Gel | 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 | -2.5 percent change | Standard Deviation 12.5 |
| Part 1: ABPO Forte Gel | 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 | -1.0 percent change | Standard Deviation 21.9 |
| Part 1: ABPO Forte Gel | 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 | -4.5 percent change | Standard Deviation 27.4 |
| Part 1: ABPO Forte Gel | 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 | -7.3 percent change | Standard Deviation 32.9 |
| Part 1: ABPO Forte Gel | 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 | -7.0 percent change | Standard Deviation 35.9 |
| Part 1: ABPO Forte Gel | 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 | -8.7 percent change | Standard Deviation 39.2 |
| Part 1: ABPO Forte Gel | 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 | -15.5 percent change | Standard Deviation 38.9 |
| Part 1: ABPO Forte Vehicle Gel | 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 | 12.3 percent change | Standard Deviation 32.5 |
| Part 1: ABPO Forte Vehicle Gel | 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 | 17.1 percent change | Standard Deviation 45.6 |
| Part 1: ABPO Forte Vehicle Gel | 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 | 14.4 percent change | Standard Deviation 53 |
| Part 1: ABPO Forte Vehicle Gel | 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 | 9.8 percent change | Standard Deviation 28.1 |
| Part 1: ABPO Forte Vehicle Gel | 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 | 5.8 percent change | Standard Deviation 19.5 |
| Part 1: ABPO Forte Vehicle Gel | 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 | 15.2 percent change | Standard Deviation 51.7 |
| Part 1: ABPO Forte Vehicle Gel | 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 | 16.2 percent change | Standard Deviation 40.7 |
| Part 2: ABPO Forte Gel | 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 | -25.0 percent change | Standard Deviation 37.1 |
| Part 2: ABPO Forte Gel | 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 | -26.9 percent change | Standard Deviation 39.7 |
| Part 2: ABPO Forte Gel | 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 | -11.7 percent change | Standard Deviation 44.9 |
| Part 2: ABPO Forte Gel | 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 | -7.1 percent change | Standard Deviation 37.3 |
| Part 2: ABPO Forte Gel | 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 | -2.6 percent change | Standard Deviation 14.2 |
| Part 2: ABPO Forte Gel | 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 | -3.6 percent change | Standard Deviation 32 |
| Part 2: ABPO Forte Gel | 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 | -21.7 percent change | Standard Deviation 42.8 |
| Part 2: ABPO Forte Gel | 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 | -0.3 percent change | Standard Deviation 25.6 |
| Part 2: ABPO Forte Gel | 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 | -8.4 percent change | Standard Deviation 40.7 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
Secondary
Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit
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.
Time frame: Part 1: Weeks 1, 4, 8, 12, 16 and 20; Part 2: Weeks 1, 4, 8, 12, 16, 20, 36 and 48
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit | Week 1 | -20.9 percent change | Standard Deviation 22.1 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit | Week 4 | -34.1 percent change | Standard Deviation 27.4 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit | Week 8 | -45.7 percent change | Standard Deviation 29.3 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit | Week 12 | -54.5 percent change | Standard Deviation 27.9 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit | Week 16 | -60.4 percent change | Standard Deviation 28.5 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit | Week 20 | -63.7 percent change | Standard Deviation 28 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit | Week 24 | -66.7 percent change | Standard Deviation 29.1 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit | Week 8 | -25.3 percent change | Standard Deviation 31.4 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit | Week 16 | -35.4 percent change | Standard Deviation 35.9 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit | Week 24 | -45.8 percent change | Standard Deviation 33.6 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit | Week 4 | -13.1 percent change | Standard Deviation 29.1 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit | Week 1 | -5.7 percent change | Standard Deviation 19.9 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit | Week 20 | -43.2 percent change | Standard Deviation 33.5 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit | Week 12 | -32.9 percent change | Standard Deviation 32.7 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit | Week 36 | -74.0 percent change | Standard Deviation 19.2 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit | Week 48 | -72.7 percent change | Standard Deviation 22.8 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit | Week 20 | -75.0 percent change | Standard Deviation 16.4 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit | Week 12 | -63.3 percent change | Standard Deviation 21.6 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit | Week 1 | -23.4 percent change | Standard Deviation 22.4 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit | Week 8 | -53.6 percent change | Standard Deviation 23.2 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit | Week 24 | -79.4 percent change | Standard Deviation 16.1 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit | Week 4 | -38.6 percent change | Standard Deviation 24.4 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit | Week 16 | -71.9 percent change | Standard Deviation 19.2 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
Secondary
Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit
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.
Time frame: Part 1: Weeks 1, 4, 8, 12, 16 and 20; Part 2: Weeks 1, 4, 8, 12, 16, 20, 36 and 48
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit | Week 20 | 10.3 atrophic acne scars | Standard Deviation 5.9 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit | Week 1 | 11.7 atrophic acne scars | Standard Deviation 6.5 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit | Week 12 | 10.7 atrophic acne scars | Standard Deviation 6.1 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit | Week 16 | 10.7 atrophic acne scars | Standard Deviation 6.2 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit | Week 4 | 11.9 atrophic acne scars | Standard Deviation 6.8 |
| Part 1: ABPO Forte Gel | Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit | Week 8 | 11.3 atrophic acne scars | Standard Deviation 6.7 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit | Week 12 | 13.8 atrophic acne scars | Standard Deviation 7.7 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit | Week 1 | 12.8 atrophic acne scars | Standard Deviation 6.8 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit | Week 4 | 13.6 atrophic acne scars | Standard Deviation 8 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit | Week 20 | 13.4 atrophic acne scars | Standard Deviation 7.5 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit | Week 16 | 13.7 atrophic acne scars | Standard Deviation 7.2 |
| Part 1: ABPO Forte Vehicle Gel | Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit | Week 8 | 13.5 atrophic acne scars | Standard Deviation 7.6 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit | Week 12 | 11.3 atrophic acne scars | Standard Deviation 6.8 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit | Week 16 | 11.0 atrophic acne scars | Standard Deviation 6.8 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit | Week 20 | 10.4 atrophic acne scars | Standard Deviation 6.5 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit | Week 36 | 8.8 atrophic acne scars | Standard Deviation 5.3 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit | Week 48 | 8.4 atrophic acne scars | Standard Deviation 5.4 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit | Week 1 | 12.2 atrophic acne scars | Standard Deviation 6.6 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit | Week 4 | 12.2 atrophic acne scars | Standard Deviation 6.8 |
| Part 2: ABPO Forte Gel | Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit | Week 8 | 11.8 atrophic acne scars | Standard Deviation 7.3 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
| Part 2: ABPO Forte Vehicle Gel | 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 |
Secondary
Part 1: Percentage of Participants With Investigator's Preference on Overall Scar Severity
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.
Time frame: At Week 12 and Week 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: ABPO Forte Gel | 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: ABPO Forte Gel | 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: ABPO Forte Gel | 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: ABPO Forte Gel | 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 |