Pilot, Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Range Finding Study, to Evaluate the Tolerability and Safety of FXFM244 Antibiotic Foam and to Monitor Its Clinical Effect in Acne Vulgaris Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Decrease in lesions count
研究概览
简要总结
The purpose of this study is to evaluate the tolerability and safety and to determine whether FXFM244 Antibiotic Foam is effective in the treatment of Acne Vulgaris.
详细描述
This is a phase IIa prospective, multicenter, randomized, double blind, placebo controlled, parallel group, dose range finding clinical study to evaluate the safety, tolerability and efficacy of Minocycline Foam 1% and 4% for the treatment of Acne Vulgaris.
The study consists of a screening / baseline visit, a treatment period where patients will be treated topically on the facial skin areas affected by acne twice daily for 12 weeks, followed by a post-treatment follow up visit 4 weeks after end of treatment. The first dose will be applied in the presence of the study investigator or his assignee. Subsequent applications will be made by the patients.
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 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of Acne Vulgaris with facial involvement.
- •A minimum of 20 but not more than 50 inflammatory lesions on the face (papules and/ or pustules).
- •A minimum of 25 but not more than 100 non-inflammatory lesions on the face (opened and/or closed comedones).
- •No significant nodulocystic acne on the face (≤ 2 lesions).
- •A score of >3 (Moderate) on the Investigator's Global Assessment Scale.
- •Patient is male or female between the ages of 12 to
- •No known medical conditions that, in the Investigator's opinion could interfere with study participation.
- •Patient is willing to refrain from use of all other topical acne medications or antibiotics during the study.
- •Patient is willing to refrain from use of moisturizers, new brands of make-up, creams, lotions, powders or any topical product other than the assigned treatment to the treatment area.
- •Patient is willing and able to comply with all requirement of the protocol.
- •Patient is willing and able to give written informed consent prior to participation in the study.
- •If female of childbearing potential, willing to use an acceptable form of birth control during the study. Use of oral contraceptives must remain constant within 3 month prior to baseline and throughout the study.
排除标准
- •Acne Conglobata, Acne Fulminas, secondary acne (chloracne, drug induced acne), or severe acne requiring systemic treatment.
- •Presence of any facial skin condition that would interfere with the diagnosis or assessment of Acne Vulgaris (e.g. rosacea, dermatitis, psoriasis, squamos cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
- •Excessive facial hair (beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of Acne Vulgaris.
- •Known or suspected hypersensitivity to Minocycline or any of the excipients in the Study Medication.
- •Concomitant medication:
- •Use within 6 month prior to baseline of topical retinoids, oral retinoids (Accutane®) or therapeutic Protocol No. FX2010-03 Foamix Ltd. Page 8 of 28 Confidential Ver: 02 Oct-31-2011 vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
- •Use of systemic steroids, systemic antibiotics, systemic treatment for Acne Vulgaris, systemic antiinflammatory agents within 4 weeks prior to baseline.
- •Use of topical steroids, α-hydroxy/glycolic acid, benzoyl peroxide, topical antibiotics, topical treatment for Acne Vulgaris, topical anti-inflammatory agents within 2 weeks prior to baseline.
- •Use for less than 3 month prior to baseline of estrogens or change in oral contraceptives therapy within less than 3 month prior to baseline;
- •Use on the face of: cryodestruction or chemodestruction, dermabrasion, photodynamic therapy, acne surgery, intralesional steroids or X-ray therapy within 4 weeks prior to baseline..
- •Alcohol or drug abuse, according to assessment by the investigator.
- •Use of another investigational drug within 30 days prior to baseline.
- •Pregnant or lactating women.
- •Use of tanning booths, sunbathing, or excessive exposure to the sun should be prohibited during the study.
- •Participation in clinical trial in the previous month.
研究组 & 干预措施
Topical Minocycline Foam FXFM244 - 4%
Active ingredient: Minocycline Concentration: 4% Route: Topical Dosage schedule: Once daily, evening.
干预措施: Topical Minocycline Foam FXFM244 (Drug)
Topical Minocycline Foam FXFM244 - 1%
Active ingredient: Minocycline Concentration: 1% Route: Topical Dosage schedule: Once daily, evening.
干预措施: Topical Minocycline Foam FXFM244 (Drug)
Placebo foam
Active ingredient: None Route: Topical Dosage schedule: Once daily, evening
干预措施: Topical Minocycline Foam FXFM244 (Drug)
结局指标
主要结局
Decrease in lesions count
时间窗: 12 weeks
The change in lesion count (inflammatory, non-inflammatory, and total) after 12 weeks of treatment compared to baseline
Investigator global assessment
时间窗: 12 weeks
Physician's Global Improvement Assessment
次要结局
- % change in lesions count(12 weeks)
- Global assessment of improvement by photographs(12 weeks)
- Subject-reported outcome assessment(12 weeks)
- Subjects safety(12 weeks)