A Study of Dapsone Gel in Females With Skin of Color and Acne Vulgaris
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 68
- 主要终点
- Change From Baseline in the Global Assessment of Acne Severity (GAAS) Score by Physician
研究概览
简要总结
This study will evaluate the effect of dapsone gel in female subjects with skin of color (Fitzpatrick Skin Types IV, V, and VI) with acne vulgaris.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of acne vulgaris
- •Medium to dark complexion (Fitzpatrick Skin Type IV, V or VI)
- •Willing to avoid excessive or prolonged exposure of the face to ultraviolet light (eg, sunlight, tanning beds) throughout the study
排除标准
- •Received treatment with botulinum toxin of any serotype in the face within 6 months
研究组 & 干预措施
Dapsone Gel
Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
干预措施: Dapsone Gel (Drug)
结局指标
主要结局
Change From Baseline in the Global Assessment of Acne Severity (GAAS) Score by Physician
时间窗: Baseline, Week 12
The investigator evaluated the participant's acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. A negative change from Baseline indicated improvement.
次要结局
- Change From Baseline in the GAAS(Baseline, Weeks 2 and 6)
- Percent Change From Baseline in Total Lesion Counts(Baseline, Weeks 2, 6 and 12)
- Percent Change From Baseline in Inflammatory Lesion Counts(Baseline, Weeks 2, 6 and 12)
- Percent Change From Baseline in Non-Inflammatory Lesion Counts(Baseline, Weeks 2, 6 and 12)
- Acne Symptom and Impact Scale (ASIS) Sign Domain Score(Weeks 2, 6 and 12)
- ASIS Impact Domain Score(Weeks 2, 6 and 12)
- Percentage of Participants With 0 (None) or 1 (Minimal) on the GAAS(Weeks 2, 6 and 12)