A Study Comparing Aczone® Plus Differin® Versus Duac® Plus Differin® in Patients With Severe Facial Acne
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 286
- 主要终点
- Percentage of Participants With at Least a One Point Decrease in the Global Acne Assessment Score (GAAS) at Week 12
研究概览
简要总结
A study comparing the topical application of Aczone® plus Differin® versus Duac® plus Differin® in patients with severe facial acne (facial acne vulgaris).
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Severe facial acne (acne vulgaris)
排除标准
- •History of significant anemia or hemolysis
- •History of enteritis (eg, regional enteritis, ulcerative colitis, pseudomembranous colitis, antibiotic-associated colitis)
- •History of lupus, rosacea, or seborrheic dermatitis
研究组 & 干预措施
Aczone® Gel 5% plus Differin® 0.3% Gel
Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks.
干预措施: Dapsone plus Adapalene (Drug)
Duac® Topical Gel plus Differin® 0.3% Gel
Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
干预措施: Clindamycin/benzoyl peroxide plus Adapalene (Drug)
结局指标
主要结局
Percentage of Participants With at Least a One Point Decrease in the Global Acne Assessment Score (GAAS) at Week 12
时间窗: Baseline, Week 12
GAAS was conducted by the investigator at Baseline and Week 12. The patient's facial acne was evaluated on a 5 point scale 0=None (no evidence of acne), 1=Minimal (few lesions), 2=Mild (several to many non-inflammatory lesions; few inflammatory lesions), 3=Moderate (many lesions) to 4=Severe (Significant degree of inflammatory disease; papules/pustules present, few nodulo-cystic lesions; comedones may be present). Papules/nodules are round, solid elevations of the skin with no visible fluid. The percentage of participants with at least a one point decrease (improvement) in GAAS was calculated.
次要结局
- Change From Baseline in Global Acne Assessment Score (GAAS) at Week 12(Baseline, Week 12)
- Percentage of Participants at Week 12 Having at Least a One Point Decrease in Overall Disease Severity(Baseline, Week 12)
- Percent Change From Baseline in Inflammatory Lesion Counts at Week 12(Baseline, Week 12)
- Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12(Baseline, Week 12)
- Percent Change From Baseline in Total Lesion Count at Week 12(Baseline, Week 12)
- Percentage of Participants Demonstrating a ≥ 1 Category Increase in Tolerability From Baseline at Week 12(Baseline, Week 12)