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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 67
- 主要终点
- Part 1: Total Atrophic Acne Scar Count Per Half-face
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Part 1: ABPO Forte Gel
干预措施: ABPO Forte Gel (Drug)
Part 1: ABPO Forte Vehicle Gel
干预措施: Vehicle gel (Drug)
Part 2: ABPO Forte Gel
干预措施: ABPO Forte Gel (Drug)
Part 2: ABPO Forte Vehicle Gel
干预措施: Vehicle gel (Drug)
结局指标
主要结局
Part 1: Total Atrophic Acne Scar Count Per Half-face
时间窗: 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.
次要结局
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- Part 1: Percentage of Participants With Investigator's Preference on Overall Scar Severity(At Week 12 and Week 24)
- 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)