NCT01347879已完成2 期
PCTA206/11 A Double Blinded, Prospective, Randomized, Vehicle Controlled Multi Center Study of Photodynamic Therapy With Visonac® Cream in Patients With Acne Vulgaris.
Photocure15 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2011年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 15
- 主要终点
- Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules).
研究概览
简要总结
This study is intended to evaluate the efficacy and safety of Visonac Photodynamic Therapy (PDT) in patients with severe acne, score 4 on global IGA scale. The null hypothesis is that Visonac PDT is equal to vehicle PDT against the alternative hypothesis that Visonac PDT is different compared to vehicle PDT at week 12.
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 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male patients, from 12-35 years of age with severe facial acne vulgaris (IGA score 4 on IGA scale)
- •Signed and verified informed consent form and photo consent form. For subjects under age of 18, an assent form in conjunction with an informed consent form, signed and verified by parent/guardian.
- •Female patients who are surgically sterile, pre-menstrual, postmenopausal, abstinent, or willing to use an adequate means of contraception including birth control pills, or barrier methods and spermicide for at least 14 days prior to T
- •Patients using birth control pills must have used the same product and dose for at least 3 months and must agree to stay with the same product and dose for an additional 3 months.
- •Fitzpatrick skin type I through VI,
- •Patients with 25 to 75 inflammatory lesions (papules, pustules, and nodules) on the face.
- •Patients with 20 to 100 non-inflammatory lesions (open and closed comedones) on the face.
排除标准
- •Patients with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)
- •Patients with more than 3 nodules on the face.
- •Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study.
- •Patients unlikely to comply with the protocol, e.g. mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the clinical study, uncooperative attitude or unlikelihood of completing the study (e.g. drug or alcohol abuse).
- •Female patients with childbearing potential (i.e. ovulation, pre-menopausal, not surgically sterilized) and sexually active, not willing to use a medically accepted contraceptive regimen (as described under inclusion criteria) while on treatment.
- •Pregnancy.
- •Participation in other clinical studies either currently or within the last 30 days.
- •Patients with porphyria.
- •Patients with cutaneous photosensitivity.
- •Known allergy to MAL, to a similar PDT compound, or to excipients of the cream
- •Patients using testosterone, any other systemic hormonal treatment or hormonal contraceptives solely for control of acne.
- •Patients who have received topical treatments for their facial acne within the last 14 days (e.g steroids, retinoids, glycolic acid, benzoyl peroxide, anti inflammatory agents, antibiotics). Medicated cleansers may be used during the washout period and stopped before the treatment.
- •Patients who have received oral antibiotics for treatment of their acne within the last month.
- •Patients who have received oral isotretinoin within the last 6 months.
- •Patient who have received facial procedures like dermabrasion, chemical or laser peels within the last 1 month.
- •Patients using testosterone, any systemic hormonal treatment for other reasons than acne treatment and has not been on the same product and dose for at least 3 months
- •Patients with moderate, severe or very severe facial acne scarring according to scarring scale described in section 10.4.
- •Patients with a beard that might interfere with study assessments.
- •Patients with melanoma or dysplastic nevi in the treatment area.
- •Exposure to ultraviolet radiation (UVB phototherapy, sun tanning salons) within the last 30 days
- •Exposure to PDT within 12 weeks before T1.
研究组 & 干预措施
Visonac cream with PDT
Experimental
active treatment with light dose of 37 Joule/cm2
干预措施: Visonac PDT (Drug)
Vehicle cream with PDT
Placebo Comparator
Placebo treatment, Light dose 37 Joule/cm2
干预措施: Vehicle cream with PDT (Drug)
结局指标
主要结局
Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules).
时间窗: From baseline to 12 weeks after first treatment
次要结局
- Absolute Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones)(From baseline to 12 weeks after the first treatment)
- Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Counts.(From baseline to 12 weeks after the first treatment)
- Proportion of Patients With Success According to IGA Scale Based on the Facial Assessment.(From baseline to 12 weeks after first treatment)
- Pain During Illumination.(Immediately after first treatment)
- Number of Patients With Adverse Events.(From administration of investigational medicinal product (IMP) until 12 weeks after first IMP administration)
- Erythema Score of Mild and Moderate(2 days after first treatment)
- Clear and Almost Clear Scarring According to Scarring Score(at week 12 after first treatment)
- Percent Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones)(From baseline to 12 weeks after first treatment)
- Erythema Score of Severe(2 days after first treatment)
- Mild and Moderate Scarring According to Scarring Score(at week 12 after first treatment)
- Severe and Very Severe Scarring According to Scarring Score(at week 12 after first treatment)
研究者
研究点 (15)
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