NCT01419964撤回3 期
Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Study of the Efficacy and Safety of ACH24 in the Treatment of Vitiligo
Ache Laboratorios Farmaceuticos S.A.1 个研究点 分布在 1 个国家开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Repigmentation of the affected area assessed by VASI (vitiligo area scoring index).
研究概览
简要总结
This is a multicenter clinical trial, phase III, randomized, placebo-controlled, parallel group, enroll 94 patients, to assess the efficacy of ACH24 in the repigmentation of achromatic areas in patients with vitiligo.
详细描述
To evaluate the efficacy and safety of ACH24 compared to placebo in the treatment of vitiligo.The present study aims to register a new product in the country, the ACH24 for the treatment of vitiligo.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes, aged between 18 and 65 years, remaining the feasibility of a legal guardian in accordance with need, able to understand and provide written informed consent and able to allow compliance at the treatment and the requirements of the protocol;
- •Presence of generalized vitiligo;
- •Able to comprehend and willing to provide written informed consent in accordance with institutional and regulatory guidelines.
排除标准
- •Patients with:
- •Inflammatory diseases;
- •Alopecia Areata;
- •Diabetes Type I;
- •Collagen disease;
- •Atopic dermatitis;
- •Psoriasis;
- •Autoimmune thyroid disease (self reported). ¬ Thyroid problems (represents 15% of people with vitiligo), exclude only those who need to do treatment with corticosteroid or immunosuppressive.
- •Women of childbearing age who had tested positive for pregnancy, or who do not use acceptable contraceptive method, or do not agree to practice reliable contraception during the study;
- •Woman in pregnancy or lactation period;
- •Known allergic reaction against the phytomedicine as assessed by medical history;
- •Patient that is taking any prohibited medication (Item 9.3);
- •Participation in last one year of clinical protocols, unless it can be direct benefit to subject;
- •Any finding of clinical observation (anamnesis and physical exam) laboratory abnormality (eg, blood glucose, blood count), disease (for example, liver, cardiovascular system, lung) or therapy that, in opinion of the investigator, may endanger the subject or interfere with the endpoints of study.
研究组 & 干预措施
Group 01
Experimental
ACH24
干预措施: Group 01 (Drug)
Group 02
Placebo Comparator
Placebo
干预措施: Group 02 (Drug)
结局指标
主要结局
Repigmentation of the affected area assessed by VASI (vitiligo area scoring index).
时间窗: Baseline compared to the end of 18 months of treatment
It is considered successful treatment a repigmentation of greater than or equal to 50% of the affected area assessed by VASI (vitiligo area scoring index).
次要结局
- Quality of life questionnaire(Baseline and each 12 weeks of treatment (V0, V3, V6, V9, V12, V15, V18))
- Safety descriptive about occurence of adverse events, evaluation of results of general physical examination.(Will be evaluated during whole study, at the baseline and after 18 months of treatment)
研究者
研究点 (1)
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