NCT04171427Unknown不适用
Evaluation of the Efficacy and the Cutaneous Acceptability of a Dermocosmetic Product in the Repigmentation of Vitiligo -Study Realized by a Dermatologist-
Laboratoire Dermatologique ACM1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年11月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- the percentage of repigmentation
研究概览
简要总结
- Study in proof of concept;
- Double blind study;
- Comparative study, versus placebo in intra-individual
- Three parallel groups testing different dosages / combinations of treatments
- Randomized.
详细描述
This study has as objectives:
Primary objective :
• Evaluate the percentage of repigmentation observed one month after the end of three months of treatment measured on an objective layer by image analysis;
Secondary objectives:
Evaluate:
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria: Sexe: female and male;
- •Age: over 18 years old;
- •Patients with stable non-segmental vitiligo lesions (defined as no new lesions or lesions that have been present for at least 3 months, lack of hypochromic margins in Wood's lumen and absence of confetti depigmentation);
- •Patients with 2 to 6 symmetrical lesions (1 to 3 on each side). These lesions (macules) will be treated for a minimum surface of 2 cm² and a maximum surface of 100 cm².
- •Healthy volunteer;
- •Volunteer having given in writing his free, informed and express consent;
- •Volunteer willing to abide by the protocol and procedures of the study.
排除标准
- •Pregnant woman or woman who is breastfeeding or planning for early pregnancy during the study;
- •Patient with segmental or mixed vitiligo;
- •Patient with vitiligo of the external genitalia;
- •Patient with vitiligo touching hands and feet only
- •Patient with a history of skin cancer or pre-cancerous skin lesions;
- •Patient taking topical or systemic vitiligo treatments in the month prior to the start of the study;
- •Patient taking concomitant local or general corticosteroid therapy or immunomodulatory therapy;
- •Patient with a history of photodermatoses or taking photosensitizing medications;
- •Patient having planned to expose himself (artificial sun or UV) during the study at the level of the zones to be treated and / or having been exposed during the month preceding the beginning of the study and having an acquired pigmentation (tanning) obvious;
- •Patient who had been treated with phototherapy within 4 weeks before randomization;
- •Patient with lithium allergy.
结局指标
主要结局
the percentage of repigmentation
时间窗: 4 months
• Evaluate the percentage of repigmentation observed one month after the end of three months of treatment measured on an objective layer by image analysis;
次要结局
- the percentage of repigmentation and acceptability(1 month, 2 months, 3 months)
研究者
研究点 (1)
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