A Phase 3 Multicenter, Randomized, Double-Blind, Active And Vehicle-Controlled Study Of The Safety And Efficacy Of CT Gel in Subjects With Acne Vulgaris
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,649
- 试验地点
- 32
- 主要终点
- Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study)
研究概览
简要总结
The purpose of this study is to demonstrate the safety and effectiveness of CT Gel in subjects with acne vulgaris. The hypothesis is that CT Gel is superior to Clindamycin Gel, Tretinoin Gel and Vehicle Gel for the treatment of acne vulgaris.
详细描述
CT Gel is a fixed-combination product that addresses the multifactorial factors of acne vulgaris pathogenesis. Based on numerous nonclinical pharmacology studies of each active ingredient, it is expected that this new product will have three biological actions: 1) comedolytic, 2) antimicrobial, and 3) anti-inflammatory.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 12 years of age or older in good general health
- •Investigator's Static Global Assessment (ISGA) score of 2 or greater at Baseline
排除标准
- •Any nodulo-cystic lesions at Baseline
- •Pregnancy or breast feeding
- •History or presence of regional enteritis or inflammatory bowel disease or similar symptoms.
- •Treatment with estrogens, including oral, implanted and topical contraceptives, androgens, or anti-androgenic agents for 12 weeks or less prior to study start.
- •Use of topical anti-acne medications within the past 2 weeks.
- •Use of topical or systemic antibiotics on the face within the past 2 weeks.
- •Use of topical or systemic corticosteroids within the past 2 weeks.
- •Use of systemic retinoids within the past 3 months.
- •Use of astringents, toners and skin cleansers for less than 2 weeks prior to the start of the study.
- •Concomitant use of facial product containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non mild cleansers or moisturizers containing retinol, salicylic or α- or β-hydroxy acids.
- •Concomitant use of mega-doses of certain vitamins, such as vitamin D (>2000IU QD) vitamin B12, haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.
- •Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 2 weeks or during the study.
- •Concomitant use of tanning booths or sunbathing.
- •Known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, retinoids or excipients of the study product
- •A significant medical history of or are currently immunocompromised
- •Current drug or alcohol abuse. (Drug screening not required.)
- •Use of any investigational therapy within 4 weeks of enrollment.
- •Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
研究组 & 干预措施
1
CT Gel
干预措施: CT Gel (Drug)
2
Clindamycin Gel (clindamycin)
干预措施: Clindamycin Gel (clindamycin ) (Drug)
3
Tretinoin Gel (tretinoin)
干预措施: Tretinoin Gel (tretinoin) (Drug)
4
Vehicle Gel
干预措施: Vehicle Gel (Drug)
结局指标
主要结局
Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study)
时间窗: Baseline, Week 12
Acne lesion counts (inflammatory \[papules, pustules, nodules\], non-inflammatory \[open and closed comedones\], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts.
The Percentage of Participants Who Had a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
时间窗: Baseline, Week 12
The ISGA is a static ("snap-shot") evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. Change is calculated as the Week 12 value minus the Baseline value.
次要结局
- The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12(Week 12)
- The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12(Week 12)
- Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12(Baseline, Week 12)