Adherence to ZIANA (Clindamycin Phosphate 1.2% With Tretinoin 0.025%)Gel Compared to Generic Topical Clindamycin Plus Generic Topical Tretinoin in Subjects With Mild to Moderate Acne Vulgaris
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Measured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne
研究概览
简要总结
The purpose of this research study is to evaluate the effectiveness of two different types of topical acne medication. This study will help to determine if one combined medication results in better acne improvement than two separate medications for 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
- Single (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
- •Males or Females 12 years of age or older with a diagnosis of mild to moderate acne vulgaris.
- •Subjects must sign written informed consent and agree to come for all study visits.
排除标准
- •Use of experimental drugs within 1 month prior to initiation of study therapy.
- •Pregnant and nursing females will not be allowed in the study, and females of childbearing potential will have a pregnancy test at baseline. Females of childbearing potential must agree to use approved birth control methods for the duration of the study.
- •Use of systemic retinoids within 2 months of enrollment, use of any topical retinoids, systemic antibiotics, nicotinamide, systemic steroids or any other medication that may confound the results of the study within 1 month prior to start of the study
- •Use of any other topical medications for acne, including cosmetics containing retinol, within 2 weeks prior to study entry.
- •Any skin condition or disease that may require concurrent therapy or may confound the evaluation;
- •History of hypersensitivity to any of the formulation components;
- •Facial skin cancer or facial actinic keratosis;
- •Use of any photosensitizing agents.
- •Use of isotretinoin within the last 6 months.
- •Chemical peels, microdermabrasion or laser resurfacing within 3 months of study entry.
- •Crohns disease, ulcerative colitis, or have developed colitis with past antibiotic use.
研究组 & 干预措施
2
Generic clindamycin 1% gel plus tretinoin 0.025% cream
干预措施: clindamycin 1% gel (Drug)
1
Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
干预措施: clindamycin phosphate 1.2% and tretinoin 0.025% (Drug)
2
Generic clindamycin 1% gel plus tretinoin 0.025% cream
干预措施: tretinoin 0.025% cream (Drug)
结局指标
主要结局
Measured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne
时间窗: 12 weeks
Percentage of prescribed doses taken as measured by a Medication Event Monitoring System (MEMS) cap
次要结局
- The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count(Baseline to 12 weeks)