A Phase 3 Multicenter, Randomized, Double-Blind, Active And Vehicle-Controlled Study Of The Safety And Efficacy Of A Clindamycin / Benzoyl Peroxide Gel Versus Clindamycin Gel Versus Benzoyl Peroxide Gel Versus Vehicle 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
- 1,315
- 试验地点
- 24
- 主要终点
- Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
研究概览
简要总结
This is a Randomized, Double-Blind, Controlled Study to evaluate the Safety and Efficacy of a clindamycin / benzoyl peroxide gel in Subjects with Acne Vulgaris
详细描述
A multicenter, randomized, double-blind, comparator and vehicle-controlled study in subjects with acne vulgaris. Approximately 1320 subjects will be enrolled. Subjects will be randomized to 1 of 4 parallel study groups in a 1:1:1:1 ratio (clindamycin / benzoyl peroxide gel:clindamycin gel:BPO gel:vehicle gel).
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 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 12 to 45 years of age, inclusive, and in good general health.
- •Clinical diagnosis of acne vulgaris
- •Females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product.
- •Have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
- •Have the ability to understand and sign a written informed consent form, which must be completed prior to study specific tasks being performed. Subjects under the legal age of consent in the state/province/country where the study is conducted must provide assent and have the written informed consent of a parent or guardian.
排除标准
- •Are pregnant or breast-feeding.
- •Have a history or presence of other conditions that may increase the risk of the subject participating in the study and/or affect the evaluated outcomes.
- •Used topical antibiotics on the face or used systemic antibiotics within the past 2 weeks.
- •Used topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular, or intra-lesional steroids other than for facial acne is acceptable.
- •Used systemic retinoids within the past 6 months or topical retinoids within the past 6 weeks.
- •Received treatment with estrogens (including oral, implanted, injected and topical contraceptives), androgens, or anti-androgenic agents for 12 weeks or less immediately prior to starting study product. Subjects who have been treated with estrogens, as described above, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to start of study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study.
- •Used topical anti-acne medications (eg, BPO, azelaic acid, resorcinol, salicylates, etc.) within the past 2 weeks.
- •Used abradents or facial procedures, within the past 2 weeks.
- •Use medications that may exacerbate acne.
- •Have a known hypersensitivity or have had previous allergic reaction to any of the active components, lincomycin, or excipients of the study product.
- •Used any investigational therapy within the past 4 weeks, or currently participating in another clinical study.
研究组 & 干预措施
1
clindamycin / benzoyl peroxide gel
干预措施: clindamycin / benzoyl peroxide gel (Drug)
2
Clindamycin gel
干预措施: clindamycin gel (Drug)
3
BPO gel
干预措施: BPO gel (Drug)
4
vehicle gel
干预措施: vehicle gel (Drug)
结局指标
主要结局
Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
时间窗: Baseline (Day 1) and Week 12
During each study visit, investigators/assessors evaluated acne severity of the participants' faces using the ISGA scale: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.
Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts
时间窗: Baseline (Day 1) and Week 12
During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules \[small inflamed elevation of the skin that is filled with pus\], papules \[solid elevation of skin with no visible fluid\], nodules \[larger than papules with significant depth\]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin). Missing values were imputed using the last observation carried forward (LOCF) method.
Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts
时间窗: Baseline (Day 1) and Week 12
During each study visit, trained study personnel at every investigational center assessed the non-inflammatory (open comedones \[blackheads\] and closed comedones \[whiteheads\]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin).
Mean Change From Baseline to Week 12 in Total Lesion Counts
时间窗: Baseline (Day 1) and Week 12
During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts.
次要结局
- Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12(Week 12)
- Mean Change From Baseline to Week 12 in Temperature(Baseline (Day 1) and Week 12)
- Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure(Baseline (Day 1) and Week 12)
- Mean Change From Baseline to Week 12 in Pulse Rate(Baseline (Day 1) and Week 12)
- Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling(Baseline; Weeks 2, 4, 8, and 12)
- Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging(Baseline; Weeks 2, 4, 8, and 12)
- Mean Duration of Study Product Use(Baseline (Day 1) through Week 12)
- Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12(Week 12)
- Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation(Baseline (Day 1) through Week 12)
- Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory)(Baseline (Day 1) and Week 12)