Punch Minigraft Versus Transverse Needling or Combination of Both in Treatment of Non-Segmental Vitiligo
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Evaluation of Type, pattern and extent of repigmentation.
研究概览
简要总结
This study is to evaluate the effectiveness and tolerability of autologous punch minigraft, transverse needling technique or combination of both followed by narrow band ultraviolet B phototherapy (311 nm) in the treatment of patients with stable non-segmental vitiligo lesions.
详细描述
Vitiligo is a common pigmentary cutaneous disorder occurring with an incidence of 1-2% worldwide, without predilection for sex or race.
The disease is characterized by gradual loss of the normal color of the skin resulting from melanin pigment loss due to the underlying destruction of the melanocyte.
Vitiligo is a multifactorial disorder with many theories explaining its pathogenesis such as autoimmunity, self-destructing mechanisms,neural mediators, biochemicals,an imbalance of epidermal cytokines and genetic factors.
Vitiligo is not a life-threatening disease,but it may cause a major social and emotional distress with significant impairment in the quality of life.
Clinically; vitiligo is classified into segmental, non-segmental and unclassified vitiligo .Non-segmental includes generalized, acrofacial,universal, mucosal (more than one mucosal site) , mixed (associated with segmental vitiligo) and other rare variants. Segmental vitiligo includes uni- ,bi- or pluri-segmental subtypes. Unclassified includes focal or mucosal (one site) subtypes.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (>16 years old) of either gender having stable non segmental vitiligo, that is resistant to other lines of repigmentation therapy.
- •Lack of progression of old lesions with the past 6 months.
- •No development of new lesions
- •Absence of history of koebner phenomenon.
- •Absence of confetti lesions or hypopigmented lesions within the past 6 months.
- •Presence of repigmentation of depigmented areas by medications or spontaneously in the past 6 months.
- •While resistance to therapy will be judged after receiving standard protocol of NB-UVB together with oral mini pulse dexamethasone at a dose of 2.5 mg on two consecutive weekly days for 3 months.
- •Patients having lesions showing absence or poor repigmentation after this regiment will be considered resistant to medical repigmentation and indicated to surgery.
排除标准
- •Cases of active, progressive disease lacking criteria of stability previously mentioned.
- •Patients with segmental or universal vitiligo covering more than 70% body surface area.
- •Patients with known associated autoimmune diseases, bleeding tendency, current or history of skin neoplasia, photosensitive disorders or any contraindications to corticosteroids therapy.
- •Patients with tendency towards hypertrophic scars or keloid formation.
- •Pregnant female and lactating mothers.
- •Patients with emotional and psychological instability.
结局指标
主要结局
Evaluation of Type, pattern and extent of repigmentation.
时间窗: 6 months
Serial photography will be done to evaluate type, pattern and extent of repigmentation.
Assessment of repigmentation
时间窗: 6 months
Assessments of repigmentation will be performed by two blinded dermatologists using a 5-point scale; grade 0 (no repigmentation), grade 1 (1%-5%), grade 2 (6%-25%), grade 3 (26%-50%), grade 4 (51%-75%) and grade 5 (76%-100%)
Digital assessment of the size of the lesion and of the depigmented versus repigmented area
时间窗: 6 months
Digital assessment of the size of the lesion and of the depigmented versus repigmented area using Adobe photoshop software
次要结局
未报告次要终点
研究者
Omneya abd el aziz abd el rehim el zagh
Principle investigator
Alexandria University