NCT01769664已完成1 期
A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel Design Study Comparing Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.) to Duac® Topical Gel Clindamycin 1%/Benzoyl Peroxide 5% (Stiefel) in the Treatment of Acne Vulgaris
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 650
- 主要终点
- Bioequivalence of test gel to reference gel
研究概览
简要总结
The objective of this study is to compare the relative efficacy and safety of the test formulation Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.) to the marketed formulation Duac® Topical Gel (Clindamycin 1%/Benzoyl Peroxide 5%) (Stiefel) in the treatment of the inflamed lesions of acne vulgaris. Both the test and reference formulations will also be compared to a placebo formulation to test for superiority.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant, non-lactating female, between 12 and 40 years of age with a clinical diagnosis of acne vulgaris.
- •Signed informed consent form. For a minor, the parent or legal guardian will sign the consent form and patient will sign assent to participate form.
- •If female of child-bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study. Patients on hormonal contraceptives must have been on the same for three months prior to baseline visit and continue throughout the duration of the study.
- •Have facial acne with 20 or more facial inflammatory lesions and 25 or more non-inflammatory lesions and 2 or less nodulocystic lesions and have an Investigator Global Assessment score of 2, 3 or
- •Willing to comply with the study requirements and restrictions including refraining from the use of all other topical acne medications or antibiotics during the treatment period.
排除标准
- •Patient has more than 2 facial nodular lesions.
- •Patient has active cystic acne.
- •Patient has acne conglobata.
- •Patients with excessive facial hair that would interfere with the diagnosis or assessment of acne.
- •Patients with tatoos or excessive facial scarring that may interfere with the evaluation of the patient's acne.
- •Patients with active facial sunburn, peeling due to sunburn and patients who will be exposed to excessive sunlight during the study.
- •Any skin condition other than acne vulgaris that would interfere with the evaluation of the patient's acne.
- •Females who are pregnant, lactating or likely to become pregnant during the study.
- •Patients with a history of or active colitis other than irritable bowel syndrome.
- •History of allergy or hypersensitivity to Clindamycin, Lincomycin or benzoyl peroxide or history of any drug hypersensitivity or intolerance which would compromise the patient's safety or the study.
- •Significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that would place the patient at undue risk by participation.
- •Use on the face within 1 month prior to screening/baseline or during the study of the following: cryodestruction or chemodestruction, dermabrasion, photodynamic therapy, acne surgery, intralesional steroids, x-ray therapy.
- •Use of the following within 1 month prior to screening/baseline: spironolactone, systemic steroids, systemic antibiotics, systemic treatment for acne vulgaris (other than oral retinoids which require a 6 month washout), systemic anti-inflammatory agents.
- •Use of oral isotretinoin (Accutane®) or oral retinoids within 6 months, or therapeutic vitamin A supplements greater than 10,000 units/day.
- •Use within 2 weeks prior to screening/baseline of the following: topical steroids, topical retinoids, topical acne treatments including over-the-counter preparations, topical anti-inflammatory agents, medicated cleansers, topical antibiotics.
- •Receipt of any drug as part of a research study within 30 days.
- •Female patients taking hormonal contraceptives or oral estrogen for less than 3 months and those that plan to change the dosage regimen during the course of the study.
- •Previous participation in this study.
- •Employees of the investigator or research center or their immediate family members.
研究组 & 干预措施
Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel
Experimental
Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.)
干预措施: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Drug)
Duac® Topical Gel
Active Comparator
Duac® (Clindamycin 1%/Benzoyl Peroxide 5%) Topical Gel (Stiefel)
干预措施: Duac® Topical Gel (Drug)
Placebo Topical Gel
Placebo Comparator
Placebo (Vehicle) Topical Gel (Taro Pharmaceuticals Inc.)
干预措施: Placebo Topical Gel (Drug)
结局指标
主要结局
Bioequivalence of test gel to reference gel
时间窗: Week 11 (study day 77)
Bioequivalence will be determined by evaluating the mean percent change from baseline to week 11 in the number of inflammatory lesions.
次要结局
- Superiority against placebo(Week 11 (study day 77))
研究者
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