Autologous Punch Grafting in Vitiligo Patients: the Effect of Punchdepth and Punchsize
试验速览
- 阶段
- 4 期
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Outgrowth of pigment after six months
研究概览
简要总结
Rationale: Punch grafting is a safe, simple and widely used technique for in vitiligo. However, no reliable data are available on the effect of punch depth and punch size.
Objectives: Primary: to compare the efficacy and safety of different punchdepths and punchsizes in punch grafting in patients with segmental and non-segmental vitiligo. Secondary: to assess the practical aspects and patients preference of different punch grafting techniques.
Study design: Prospective observer blinded randomised controlled study. Study population: 35 patients ≥ 18 years with segmental or stable non-segmental vitiligo who will receive regular treatment by punch grafting at the Netherlands Institute for Pigment Disorders (SNIP) at the Academic Medical Centre University of Amsterdam.
Methods: Four depigmented regions on the trunk or upper extremities will be randomly allocated to either epidermal 1,5 mm punch grafting, epidermal 1mm punch grafting, dermal 1,5 mm punch grafting and dermal 1 mm punch grafting. After grafting, all regions will receive UV-therapy twice a week for 3 months. Three and six months after grafting, the repigmentation of the lesions will be assessed by measuring the outgrowth.
Main study parameter/endpoint: Outgrowth of pigment after six months.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The study involves 16 additional punch grafts but no additional visits to our institute. Patients will not miss any regular treatment. The extra time due to participation in the study will be about 40 minutes. No increase of the risk of side effects is expected by placing 16 additional punch grafts. 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with non-segmental and segmental vitiligo under medical treatment at the Netherlands Institute for Pigment Disorders
- •Age between 18 and 60 years
- •Patient is willing and able to give written informed consent
- •Vitiligo stable since 12 months without systemic therapy or 6 months without topical therapy as defined by the absence of new lesions and/or enlargement of existing lesions.
- •Vitiligo lesions on the extremities or trunk larger than 5x5cm
排除标准
- •UV therapy or systemic immunosuppressive treatment during the last 12 months
- •Local treatment of vitiligo during the last 6 months
- •Vitiligo lesions with folliculair or non-folliculair repigmentations
- •Skin type 1
- •Hypertrophic scars
- •Cardial insufficiency
- •Patients with a history of hypersensitivity to (UVB) light and allergy to local anesthesia.
- •Patients who are pregnant or breast-feeding
- •Patients not competent to understand what the procedures involved
- •Patients with a personal history of melanoma or non-melanoma skin cancer
- •Patients with a first degree relative with melanoma skin cancer
- •Patients with atypical nevi.
结局指标
主要结局
Outgrowth of pigment after six months
时间窗: at 3 and 6 months after treatment
Objective assessment of the repigmentation 3 and 6 months after punch grafting. Assessment will be done using a ruler on a dermatoscope to measure the diameter of the growth of the punchgrafts. The surface of repigmentation will be calculated.
次要结局
- Visual assessment of side effects(at 3 and 6 months after treatment)