A Multi Center, Randomized, Double Blind, Placebo Controlled, 3 Arm, Parallel Group Study Comparing the Efficacy and Safety of CD2475/101 40 mg Tablets Versus Placebo and Doxycycline 100 mg Capsules Once Daily in the Treatment of Inflammatory Lesions in Subjects With Acne Vulgaris
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 662
- 试验地点
- 31
- 主要终点
- Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])
研究概览
简要总结
The primary objectives of the study is to show CD2475/101 40mg tablets taken once a day for 16 weeks is superior to the placebo in Change from baseline to Week 16(Last Observation Carry Forward, Intent To Treat) in inflammatory lesion counts.
详细描述
Investigator's global assessment and lesion count will be performed at each study visit.
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 and female subjects 12 years of age or older
- •acne vulgaris with facial involvement
- •A score of 3 (Moderate) or 4 (Severe) on the Investigator's Global Assessment Scale (inflammatory)
- •25 to 75 inflammatory lesions (papules and pustules) on the face (including the nose)
排除标准
- •More than two acne nodules/cysts on the face
- •Acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne, etc.), or severe acne requiring systemic retinoid treatment
- •Underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea
- •Beard or facial hair which might interfere with study assessments
- •planning excessive exposure to sun or ultraviolet light during the study (i.e. natural or artificial sunlight, including tanning booths and sun lamp)
- •Use of oral contraceptives solely for control of acne
- •Liver function test alanine transaminase (ALT) and/or aspartate transaminase (AST) 2.5 times above upper limit of normal
- •Renal function test serum creatinine at 150 umol/L (17 mg/L) or higher
- •Presence of oral or genital candidiasis or history of multiple episodes of oral or genital candidiasis
- •Females who intend to conceive a child within 5 months following Baseline visit
- •Males who intend to conceive a child with partner during the study period
- •Requiring concomitant use of methoxyflurane
研究组 & 干预措施
CD2475/101 40 mg
Participants receive 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.
干预措施: CD2475/101 40 mg (Drug)
CD2475/101 40 mg
Participants receive 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.
干预措施: Placebo (Drug)
Doxycycline 100 mg
Participants receive 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.
干预措施: Doxycycline 100 mg (Drug)
Doxycycline 100 mg
Participants receive 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.
干预措施: Placebo (Drug)
Placebo
Participants receive matching placebo tablet plus placebo capsule orally once daily for 16 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])
时间窗: From Baseline up to Week 16 (LOCF)
The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 0.5 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. Change from baseline in inflammatory lesion counts to Week 16 (LOCF) were reported.
次要结局
- Change From Baseline in Non-Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])(From Baseline up to Week 16 (LOCF))
- Global Assessment for Inflammatory Lesions of Truncal Acne at Baseline, Week 12, and Week 16(Baseline, Week 12, and Week 16)
- Number of Participants With at Least One Adverse Event (AE)(From Baseline up to Week 16)
- Investigator Global Assessment (IGA) Success Rate at Week 16 (Last Observation Carried Forward [LOCF])(Week 16 (LOCF))
- Percent Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])(From Baseline up to Week 16 (LOCF))
- Percent Change From Baseline in Total Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])(From Baseline up to Week 16 (LOCF))