A Randomized Controlled Pilot Study to Examine the Use of Micrografting, Using a Novel Grafting Technique for the Repigmentation of Vitiligo
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Change in Target VASI Score From Baseline to Week 24.
研究概览
简要总结
This study evaluates micrografting using a harvesting and grafting process that has been designed by Momelan Technologies. The overall concept is to harvest several small pieces of skin, each measuring about 1.75 mm in diameter from a normal pigmented area using a commercially available suction blister device, adhere them to a sterile elastomeric substrate and is then place it on a recipient area prepared by epidermal dermabrasion (removal of the epidermis).
详细描述
Participants with vitiligo patches undergo removal of the epidermis of the affected vitiligo skin with dermabrasion. Several small pieces of pigmented skin (1.75mm) from the patient are taken from another area with the use of a suction blister device. The harvested pigmented skin is adhered to a sterile elastomeric substrate and placed on the previously dermabraded affected area.
Originally the primary outcome was percentage of change in pigmentation with UV photos at 10 weeks in sites undergoing grafts compared to control sites. However, because we were unable to take UV photos, we had to revise our primary outcome.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 18 to 80 years old
- •Have a diagnosis of stable vitiligo as defined by Vitiligo Disease Activity Score of 0 or 1
- •Has 3 comparable vitiliginous areas of trunk or extremities (excluding hands) each measuring at least 3cm×3cm in size, with at least 80% of depigmentation, and anticipated equal sun exposure.
- •Have not used any topical therapy to patches or Ultraviolet light therapy for at least 2 weeks (subjects may restart phototherapy at week 10 if desired)
- •Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
- •Agree to follow and undergo all study-related procedures
排除标准
- •Female patients who are breastfeeding, pregnant, or planning to become pregnant
- •Patients with a history of hypertrophic scaring or keloids and psoriasis
- •Subjects on any dose of coumadin, warfarin, Plavix or at least 325 mg aspirin.
- •Concurrent use of immunosuppressive medications such as oral steroids, tacrolimus and other cytotoxic reagents within 2 weeks of grafting)
- •Subject who received topical therapy or UV light ( phototherapy)in last 2 weeks
- •Patients with a positive HIV status
- •Patients withDiabetes Mellitus with a hemoglobin A1C of more than
- •Subjects with dermatologic conditions that may Koebnerize such as psoriasis and lichen planus.
- •Participation in another interventional study with potential exposure to an investigational drug within past 30 days
研究组 & 干预措施
Dermabrasion-Micrografting
Dermabrasion-Micrografting
干预措施: Dermabrasion-Micrografting (Device)
Dermabrasion alone
Dermabrasion alone
干预措施: Dermabrasion (Procedure)
Control
Control
结局指标
主要结局
Change in Target VASI Score From Baseline to Week 24.
时间窗: 24 weeks
Target Vitiligo Area Scoring Index (VASI) consists of a 7-point scale ranging from 0 (no change in depigmentation) to 6 (complete repigmentation).
次要结局
- Incidence of Adverse Effects, Including Increased Activity of Vitiligo(24 weeks)
研究者
Alexandra Kimball
Director, Clinical Unit for Research Trials in Skin
Massachusetts General Hospital