Back to resultsAdapalene 0.3% - Benzoyl Peroxide 2.5% Gel and Risk of Formation of Atrophic Acne Scars (OSCAR)
Primary Purpose
Acne Vulgaris, Atrophic Acne Scars
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
ABPO Forte Gel
Vehicle gel
Sponsored by
About this trial
This is an interventional prevention trial for Acne Vulgaris focused on measuring acne, scars
Eligibility Criteria
Main Inclusion Criteria:
Participants with clinical diagnosis of moderate to severe acne vulgaris on the face defined by:
- Investigator's Global Assessment score of 3 or 4, with same score on both sides; and
- A minimum of 25 inflammatory lesions (papules and pustules) in total, with at least 10 on each side (excluding the nose); and
- No more than two acne nodules (less than or equal to [>=] 1 centimeter [cm]); and
- 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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Part 1: ABPO Forte Gel
Part 1: ABPO Forte Vehicle Gel
Part 2: ABPO Forte Gel
Part 2: ABPO Forte Vehicle Gel
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02735421
Brief Title
Adapalene 0.3% - Benzoyl Peroxide 2.5% Gel and Risk of Formation of Atrophic Acne Scars
Acronym
OSCAR
Official Title
Effect of Adapalene 0.3% - Benzoyl Peroxide 2.5% Gel Versus Vehicle Gel on the Risk of Formation of Atrophic Acne Scars in Moderate to Severe Acne Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 13, 2016 (Actual)
Primary Completion Date
June 5, 2017 (Actual)
Study Completion Date
November 23, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris, Atrophic Acne Scars
Keywords
acne, scars
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1: ABPO Forte Gel
Arm Type
Experimental
Arm Title
Part 1: ABPO Forte Vehicle Gel
Arm Type
Placebo Comparator
Arm Title
Part 2: ABPO Forte Gel
Arm Type
Experimental
Arm Title
Part 2: ABPO Forte Vehicle Gel
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ABPO Forte Gel
Other Intervention Name(s)
TactuPump Forte
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Vehicle gel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Part 1: Total Atrophic Acne Scar Count Per Half-face
Description
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
Secondary Outcome Measure Information:
Title
Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit
Description
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
Title
Part 1 and Part 2: Percent Change From Baseline in Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit
Description
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
Title
Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score
Description
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
Title
Part 1: Percentage of Participants With Investigator's Preference on Overall Scar Severity
Description
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
Title
Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit
Description
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
Title
Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit
Description
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
Title
Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit
Description
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
Title
Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria:
Participants with clinical diagnosis of moderate to severe acne vulgaris on the face defined by:
Investigator's Global Assessment score of 3 or 4, with same score on both sides; and
A minimum of 25 inflammatory lesions (papules and pustules) in total, with at least 10 on each side (excluding the nose); and
No more than two acne nodules (less than or equal to [>=] 1 centimeter [cm]); and
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).
Facility Information:
City
Markham
State/Province
Ontario
Country
Canada
City
Oakville
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Windsor
State/Province
Ontario
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
City
Saint Jérôme
State/Province
Quebec
Country
Canada
City
Nantes
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
31209851
Citation
Dreno B, Bissonnette R, Gagne-Henley A, Barankin B, Lynde C, Chavda R, Kerrouche N, Tan J. Long-Term Effectiveness and Safety of Up to 48 Weeks' Treatment with Topical Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in the Prevention and Reduction of Atrophic Acne Scars in Moderate and Severe Facial Acne. Am J Clin Dermatol. 2019 Oct;20(5):725-732. doi: 10.1007/s40257-019-00454-6.
Results Reference
background
PubMed Identifier
29549588
Citation
Dreno B, Bissonnette R, Gagne-Henley A, Barankin B, Lynde C, Kerrouche N, Tan J. Prevention and Reduction of Atrophic Acne Scars with Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in Subjects with Moderate or Severe Facial Acne: Results of a 6-Month Randomized, Vehicle-Controlled Trial Using Intra-Individual Comparison. Am J Clin Dermatol. 2018 Apr;19(2):275-286. doi: 10.1007/s40257-018-0352-y.
Results Reference
background
Learn more about this trial
Adapalene 0.3% - Benzoyl Peroxide 2.5% Gel and Risk of Formation of Atrophic Acne Scars
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