A Double-Blind, Placebo-Controlled, Pilot Study to Determine the Safety and Efficacy of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel For The Treatment of Rosacea Over 12 Weeks
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Mean Change in Number of Inflammatory Lesions From Baseline to Week 12
研究概览
简要总结
The purpose of this study is to determine whether Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel are effective and safe in the treatment of papulopustular rosacea.
详细描述
Currently, there is no known cure for rosacea. The most effective treatment is systemic antibiotics, particularly of the tetracycline family. Topical treatments include metronidazole, antibacterials such as erythromycin and clindamycin, sulfacetamide and benzoyl peroxide. Isotretinoin (Accutane) is also used.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 18 years of age and older.
- •Clinical diagnosis of papulopustular facial rosacea.
- •A minimum of 4 but not more than 50 facial inflammatory lesions (papules plus pustules).
- •Willing and able to understand and sign informed consent.
- •Able to complete study and comply with study procedures.
排除标准
- •Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment.
- •History or presence of regional enteritis or inflammatory bowel disease (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis, bloody diarrhea) or similar symptoms.
- •Use of topical rosacea treatments in the past 2 weeks.
- •Use of systemic antibiotics in the past 4 weeks.
- •Use of systemic retinoids within the past 3 months.
- •Use of laser or light based rosacea treatments within the past 2 months.
- •Concomitant use of medications that are reported to exacerbate rosacea, such as topical and systemic steroids as these may impact assessments.
- •Current drug or alcohol abuse.
- •Other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis or acne vulgaris.
- •Clinically significant abnormal findings or conditions (other than rosacea), which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
- •Subjects who are pregnant or planning a pregnancy.
- •Use of any investigational therapy within the past 4 weeks.
- •Known hypersensitivity or previous allergic reaction to clindamycin or retinoids
研究组 & 干预措施
Clindamycin/Tretinoin Gel
Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, chin, cheeks) once daily at night for 12 weeks
干预措施: Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel (Drug)
Placebo gel
Participants applied Placebo gel with no active medication on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks.
干预措施: Placebo gel (Drug)
结局指标
主要结局
Mean Change in Number of Inflammatory Lesions From Baseline to Week 12
时间窗: Baseline, week 12
The number of inflammatory lesions (papules and pustules) on the face were counted by a dermatologist at baseline and week 12 for each participant. Change in the number of inflammatory lesions is defined as week 12 values minus the baseline values of the participant. Last observation carried forward (LOCF) method was used for missing values.
次要结局
未报告次要终点
研究者
Alexandra Kimball
Director, Clinical Unit for Research Trials in Skin
Massachusetts General Hospital