NCT02944461已完成4 期
Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Percent of Subjects Who Achieve at Least a Two Grade Improvement and a Rating of Clear or Almost Clear on the Investigator Global Assessment (IGA) Scale
研究概览
简要总结
To determine if Dapsone (Aczone) 7.5% gel is a safe and effective treatment for acne on the trunk
详细描述
This is an open label pilot study to determine the safety and efficacy of Dapsone (Aczone) 7.5% gel applied daily to the trunk for acne. Subjects will apply Dapsone for 16 weeks.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects of any race and at least 12 years of age.
- •Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline and practice a reliable method of contraception throughout the study.
- •Truncal acne IGA score of
- •Able to understand the requirements of study and sign Informed Consent/HIPAA forms.
排除标准
- •Female subjects who are pregnant , breast feeding or are of childbearing potential who are not willing to use a reliable method birth control.
- •Subjects who have an allergy or sensitivity to any component of the test medication.
- •Subjects who have not complied with the proper wash out periods for prohibited medications.
- •Evidence of recent drug or alcohol abuse.
- •Skin disease /disorder that might interfere with the diagnosis or evaluation of truncal acne.
- •Exposure to an investigational drug within 30 days of the Baseline visit.
- •Medical condition that contraindicates the subject's participation in the study.
- •History of poor cooperation, non-compliance with medical treatment or unreliability.
研究组 & 干预措施
Dapsone gel 7.5%
Experimental
Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks.
干预措施: Dapsone 7.5 % gel (Drug)
结局指标
主要结局
Percent of Subjects Who Achieve at Least a Two Grade Improvement and a Rating of Clear or Almost Clear on the Investigator Global Assessment (IGA) Scale
时间窗: 16 weeks
Investigator will evaluate global acne severity using the IGA scale as follows: 1= Clear Skin, 2 = Almost Clear, 3 = Mild Severity, 4 = Severe, 5 = Very Severe
次要结局
- The Percent Change in Inflammatory Lesion Count at Week 16 Compared to Baseline(16 Weeks)
- The Percent Change in Non-inflammatory Lesion Count at Week 16 Compared to Baseline(16 Weeks)
- The Percent Change in Total Lesion Count at Week 16 Compared to Baseline(16 Weeks)
研究者
研究点 (3)
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