Autologous Transplantation of Hair Follicles for the Treatment of Vitiligo on Glabrous Skin
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Percentage of repigmentation assessed by 4 point scale
研究概览
简要总结
There are several surgical methods to treat vitiligo patches, and follicular unit extraction (FUE) is one among them. FUE, performed using punch biopsy extraction and hair follicle transplantation, has proven safe and effective in multiple studies for treatment of hair bearing (non-glabrous) skin. This technique has not yet been trialed on hairless areas (glabrous skin) affected by vitiligo, such as the lips, fingertips, knuckles, wrists, and feet, which tend to be resistant to standard treatments. We suspect this technique will be successful in patients who have responded well to other therapies in all areas except for non-hair bearing areas.
详细描述
Vitiligo is an autoimmune skin condition that can have a profound psychosocial impact on patients. Vitiligo is caused by an immune-mediated destruction of melanocytes, or the cells responsible for producing melanin, which gives the skin its pigment. There are safe and effective treatments for vitiligo, which should be selected based on disease subtype, the percentage of body surface area involved, patient preference, and the impact of the disease on a patient's quality of life. Treatment aims to stabilize depigmented lesions, reduce disease progression and stimulate repigmentation. The current therapies available include topical and systemic immunosuppressants, phototherapy and surgical techniques.
The autologous transplantation of hair follicles has the ability to treat hairless areas by introducing follicular stem cells to an area of skin that would otherwise not respond to current treatment options. The potential to treat glabrous areas is of particular relevance for this technique, and the question proposed in this study is whether the same procedure of follicular hair transplant that has been previously safely and successfully used to treat segmental/stable vitiligo in hair bearing areas can applied to treat vitiligo in glabrous skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adults 18 years and older
- •Vitiligo patients already on treatment who demonstrate stable disease (have noted some repigmentation in hair bearing areas)
- •Willingness to participate in the study
- •Willingness to undergo biopsies of full-thickness skin tissue from areas without vitiligo and having them transplanted into areas with vitiligo
- •Informed consent agreement signed by the subject
排除标准
- •Adults unable to consent (adults lacking capacity)
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
- •Unable to return for follow-up visits
- •Infection or other dermatologic condition different than vitiligo in the area to be treated
- •Personal or family history of keloid formation
- •Known allergies to injectable lidocaine or other topical anesthetics
- •Systemic immunosuppressive medication (oral corticosteroids) within prior 4 weeks
- •Topical steroids at planned recipient site within the prior 1 week
- •Individuals who are unwilling to discontinue topical steroids at recipient site
- •Prescription or over-the-counter medication or cosmetics containing: retinoids, glycolic acid, salicylic acid, topical steroids at the site of treatment or oral corticosteroids, or any other remedies that might affect the healing process. Non-medicated moisturizers are allowed.
- •Co-existent inflammatory skin disease
- •Any other condition or laboratory value that would, in the professional opinion of the investigators, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
结局指标
主要结局
Percentage of repigmentation assessed by 4 point scale
时间窗: evaluated at 3 month follow up visit
Assessments of repigmentation will be performed by two dermatologists who will use photographs to determine percentage of repigmentation using the following scale: (excellent= 100%-95%, good= 94%-65%, fair= 64%-25%, poor= 24%-0%)
Percentage of patients with successful engraftment of hair follicles to transplant site
时间窗: evaluated 10 days post-procedure visit
Assessed by acceptance or rejection of graft into transplant site. Dermatologist will monitor for signs of rejection including infection, non-healing wounds, and necrosis of transplanted tissue and determine if transplant was successful (yes) or not (no), and the total percentage of successful cases will be calculated.
次要结局
未报告次要终点
研究者
Mehdi Rashighi
Principal Investigator
University of Massachusetts, Worcester