A Prospective, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of a Combination of 3% Minocycline and 0.3% Adapalene Topical Foam Formulation for the Treatment of Moderate-to-Severe Acne (Study FX2016 40)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 446
- 试验地点
- 35
- 主要终点
- Absolute change from Baseline in inflammatory lesion counts at week 12
研究概览
简要总结
A study comparing FCD105 to 3% minocycline foam, 0.3% adapalene foam and vehicle foam in patients ≥ 12 years old for the treatment of moderate-to-severe acne.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has facial acne vulgaris with all of the following:
- •20 to 50 inflammatory lesions (papules and/or pustules) on the face.
- •25 to 100 non-inflammatory lesions (open and closed comedones) on the face.
- •IGA score of moderate (3) to severe (4).
- •No more than two active nodules on the face.
- •Willing to use only the supplied non-medicated cleanser and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study
排除标准
- •Female who is pregnant or lactating, or is planning a pregnancy during the study.
- •Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face that could interfere with the clinical evaluations.
- •Facial hair (eg, beard, mustache, etc.) that could interfere with the clinical evaluations.
- •Sunburn on the face.
- •Severe systemic disease as assessed by the Investigator that might interfere with the conduct of the study or the interpretation of the results.
- •Subjects who have a documented history of any of the following:
- •Allergy to tetracycline-class antibiotics or to any ingredient in the study drug.
- •Pseudomembranous colitis or antibiotic-associated colitis.
- •Hepatitis or clinically significant liver damage or clinically significant renal impairment.
- •Known or suspected premalignant or malignant disease (excluding successfully treated skin cancers).
- •Subjects who have used the following medications:
- •Within 1 week prior to randomization:
- •Medicated facial cleansers on the face.
- •Topical acne treatments on the face (other than those listed below).
- •Within 4 weeks prior to randomization:
- •Topical retinoids on the face.
- •Topical anti-inflammatories and/or corticosteroids on the face.
- •Topical corticosteroids on body areas other than the face for more than 15 consecutive days and on more than 10% of the body surface area. In body folds, such as axillary and inguinal regions, only mild topical steroids are allowed for short term use (≤15 consecutive days).
- •Systemic antibiotics.
- •Systemic acne treatments.
- •Within 12 weeks prior to randomization:
- •Systemic retinoids.
- •Systemic corticosteroids (Note: Intranasal and inhaled corticosteroids may be used throughout the study if the subject is on a stable dose).
- •Use of sauna during the 2 weeks prior to randomization.
- •Epilation of the face within 2 weeks prior to randomization.
- •Folliculitis on the face.
- •Documented history of depression that is not, in the opinion of the Investigator, currently adequately controlled with medication
研究组 & 干预措施
FCD105 Foam
FCD105 Foam
干预措施: FCD105 (Combination Product)
3% Minocycline Foam
3% Minocycline Foam
干预措施: 3% Minocycline Foam (Drug)
0.3% Adapalene Foam
0.3% Adapalene Foam
干预措施: 0.3% Adapalene Foam (Drug)
Vehicle Foam
Vehicle Foam
干预措施: Vehicle Foam (Other)
结局指标
主要结局
Absolute change from Baseline in inflammatory lesion counts at week 12
时间窗: 12 weeks
Statistical superiority of FCD105 vs. vehicle in the absolute change from Baseline in inflammatory lesion counts at Visit 4 (Week12/End of Treatment)
Investigator's Global Assessment (IGA) Treatment Success at Week 12
时间窗: 12 weeks
Statistical superiority of FCD105 vs. vehicle in in IGA Treatment Success at Visit 4 (Week 12/End of Treatment), where success is defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from Baseline.
Absolute change from Baseline in non-inflammatory lesion counts at week 12
时间窗: 12 weeks
Statistical superiority of FCD105 vs. vehicle in the absolute change from Baseline in non-inflammatory lesion counts at Visit 4 (Week12/End of Treatment)
次要结局
未报告次要终点