NCT03615768已完成3 期
A Multi-center, Randomized, Single-blind, Paralelle, Positive Controlled Phase III Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Moderate Acne Vulgaris
Lee's Pharmaceutical Limited1 个研究点 分布在 1 个国家目标入组 1,617 人开始时间: 2018年8月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,617
- 试验地点
- 1
- 主要终点
- Percentage Change From Baseline in Total Lesion Counts
研究概览
简要总结
This is a study to see if Adapalene-Clindamycin Combination Gel is effective and safe in the treatment of acne vulgaris, compared to adapalene gel alone and clindamycin gel alone. Adapalene and clindamycin have been reported to have a better effect in acne treatment when used together. This new formulation is also easier to use as it combines two products into a single gel and only needs to be used once a day.
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 (Outcomes Assessor)
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 female, aged 12-40 years old
- •Diagnosis of Grade II-III acne vulgaris with Pillsbury grading system
- •Provide written informed consent if the subject is aged 18 or older. Ages 12-17 should provide written assent and written informed consent from patient's parent or legal guardian.
排除标准
- •Known hypersensitivity to adapalene, clindamycin hydrochloride, clindamycin phosphate, lincomycin or any ingredient of the study drug, or of allergic constitution
- •Secondary Acne, such as occupational acne and steroid acne
- •Has a dermatological condition of the face that could interfere with the clinical evaluations, such as sunburn, psoriasis, seborrheic dermatitis or eczema
- •History of Crohn's disease, ulcerative colitis or antibiotic-associated colitis
- •History of serious heart disease or hypertension
- •Serious liver or kidney disease, AST or ALT more than twice the upper limit of normal, or Cr above normal
- •Serious endocrine, hematologic or psychiatric disease
- •Known immunocompromised conditions, or require long-term steroids or immunosuppressants
- •Females who are pregnant, lactating, or not willing to use effective contraception
- •Drug or alcohol abuse
- •Used any topical acne treatment within 2 weeks
- •Used any systemic retinoid, antibiotic or other acne treatment
- •Used any investigational drugs or device within 3 months, or concurrently enrolled in another clinical trial
- •Patient who the investigator deemed to be unsuitable for any reason
研究组 & 干预措施
Adapalene-Clindamycin Combination Gel
Experimental
干预措施: Adapalene-Clindamycin Combination Gel (Combination Product)
Adapalene Gel
Active Comparator
干预措施: Adapalene Gel (Drug)
Clindamycin Gel
Active Comparator
干预措施: Clindamycin Gel (Drug)
结局指标
主要结局
Percentage Change From Baseline in Total Lesion Counts
时间窗: Week 12
Percent change from Baseline in total lesions counts in each treatment group at Week 12.
Proportion of patients who has at least a two-point reduction in Investigator Global Assessment (IGA) compared to baseline
时间窗: Week 12
次要结局
- Percentage change from baseline in inflammatory lesion counts(Week 12)
- Change from baseline in inflammatory lesion counts(Week 12)
- Change from baseline in total lesion counts(Week 12)
- Treatment success rate(Week 12)
- Change from baseline in non-inflammatory lesion counts(Week 12)
- Change from baseline in Investigator's Global Assessment (IGA)(Week 12)
- Percentage change from baseline in non-inflammatory lesion counts(Week 12)
研究者
研究点 (1)
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