NCT00757523已完成4 期
A Multi-center, Randomized, Evaluator-blind, Parallel-group Evaluation of the Efficacy, Safety, and Tolerability of Duac Akne Gel and Epiduo Gel in the Topical Treatment of Facial Acne Vulgaris
Stiefel, a GSK Company1 个研究点 分布在 1 个国家目标入组 382 人开始时间: 2008年9月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 382
- 试验地点
- 1
- 主要终点
- Percent change in inflammatory lesion count from Baseline to Week 12
研究概览
简要总结
The purpose of this study is to compare the effectiveness of two marketed products in subjects with facial acne vulgaris
详细描述
Multiple physiopathological factors have been associated with acne vulgaris. Drug combinations are frequently used to address these factors and to improve efficacy in the treatment of acne. The current study proposes to compare a fixed-dose (once-daily) combination gel product containing benzoyl peroxide (BPO)and clindamycin against a fixed-dose (once-daily) combination gel product containing BPO and adapalene for the treatment of facial acne vulgaris.
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 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females 12 to 45 years of age, inclusive, in good general health.
- •Clinical diagnosis of acne vulgaris
- •Capable of understanding and willing to provide signed and dated written voluntary informed consent
- •Female subjects of childbearing potential must have a negative pregnancy test at baseline. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception
- •Subjects who have been treated with estrogens, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to the first dose of study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study.
- •The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
排除标准
- •Female subjects who are pregnant, trying to become pregnant, or who are lactating.
- •Any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases or diseases of the facial skin other than acne vulgaris.
- •Facial hair that may obscure the accurate assessment of acne grade.
- •History or presence of regional enteritis or inflammatory bowel disease (eg, ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms.
- •Used topical antibiotics on the face or systemic antibiotics within the past 2 and 4 weeks, respectively.
- •Used topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra articular or intra-lesional (other than for facial acne lesions) steroids is acceptable.
- •Used systemic retinoids within the past 6 months.
- •Using drugs known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of increased phototoxicity.
- •Using neuromuscular blocking agents. Clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents.
- •Used topical anti-acne medications (eg, BPO, retinoids, azelaic acid, resorcinol, salicylates, sulfacetamide sodium and derivatives, glycolic acid) within the past 2 weeks.
- •Used any investigational therapy within 4 weeks of study day
- •Using the following types of facial products: astringents, toners, abradants, facials, peels containing glycolic or other acids, masks, washes or soaps containing BPO, sulfacetamide sodium or salicylic acid, non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or α- or β-hydroxy acids.
- •Using medications that are reported to exacerbate acne (eg, mega-doses of certain vitamins such as vitamin D, vitamin A, and vitamins B2, B6, and B12; haloperidol; halogens such as iodide and bromide; lithium; hydantoin; and phenobarbital) as these may impact efficacy assessments.
- •Have had a facial procedure (chemical or laser peel, microdermabrasion, artificial ultraviolet [UV] therapy) performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks.
- •Have a known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, adapalene, clindamycin, BPO, or excipients of the study medication.
- •Employees of a clinical research organization involved in the study, or Stiefel Laboratories, or an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee.
- •Have a member of the same household in this trial.
研究组 & 干预措施
Epiduo Gel
Active Comparator
Epiduo Gel (combination of 0.1% adapalene and 2.5% benzoyl peroxide (BPO) in a gel preparation).
干预措施: Epiduo Gel (Drug)
Duac Gel
Experimental
Duac Akne Gel (combination of 1% clindamycin phosphate and 5% benzoyl peroxide (BPO) in a gel preparation).
干预措施: Duac Gel (Drug)
结局指标
主要结局
Percent change in inflammatory lesion count from Baseline to Week 12
时间窗: Baseline (Day 1) and Week 12
The efficacy assessor performed a count of inflammatory lesions (papules and pustules, including nasal lesions) each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Week 12.
次要结局
- Percent change in total lesion count from Baseline to week 12(Baseline (Day 1) and Week 12)
- Percentage of participants who achieved treatment success, defined as improvement of 2 grades or more in their Investigator Static Global Assessment (ISGA) acne severity scale from Baseline to Week 12(Week 12)
- Time to 2-grade improvement in ISGA from Baseline(Week 12)
- Absolute change in inflammatory lesion count from Baseline to Week 12.(Baseline (Day 1) and Week 12)
- Absolute change in non-inflammatory lesion count from Baseline to Weeks 1 2, 4,8(Baseline (Day 1) and Weeks 1,2,4,8)
- Absolute change in non-inflammatory lesion count from Baseline to Week 12(Baseline (Day 1) and Week 12)
- Time to reach 50 percent reduction in non-inflammatory lesion counts from Baseline(Week 12)
- Absolute change in inflammatory lesion count from Baseline to Weeks 1, 2, 4, 8(Baseline (Day 1) and Weeks 1, 2, 4, 8)
- Absolute change in total lesion count from Baseline to Weeks 1, 2, 4, 8(Baseline (Day 1) and Weeks 1, 2, 4, 8)
- Absolute change in total lesion count from Baseline to Week 12(Baseline (Day 1) and Week 12)
- Percentage of participants who achieved treatment success from Baseline to Weeks 1, 2, 4, and 8(Weeks 1, 2, 4, and 8)
- Percent change in non-inflammatory lesion count from Baseline to Weeks 1, 2, 4, 8(Baseline (Day 1) and Weeks 1, 2, 4, 8)
- Percent change in non-inflammatory lesion count from Baseline to Week 12(Baseline (Day 1) and Week 12)
- Percent change in inflammatory lesion count from Baseline to Weeks 1, 2, 4, and 8(Baseline (Day 1) and Weeks 1, 2, 4, and 8)
- Percent change in total lesion count from Baseline to Weeks 1, 2, 4, and 8(Baseline (Day 1) and Weeks 1, 2, 4, and 8)
- Time to reach 50 percent reduction in inflammatory lesion counts from Baseline(Week 12)
- Time to reach 50 percent reduction in total lesion counts from Baseline(Week 12)
- Percentage of participants who had a Subject's Global Change Assessment score (SGAC) of 0 or 1 at Weeks 1, 2, 4, 8, and 12(Upto Week 12)
研究者
研究点 (1)
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