Fractional Carbon Dioxide Laser Combined With Topical Corticosteroid and Narrow Band Ultraviolet B in Treatment of Stable Vitiligo.
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 主要终点
- VASI scor-Vitiligo Area and Severity Index:
研究概览
简要总结
Vitiligo is an acquired disease with a variable course. It is characterized clinically by well-defined depigmented macules or patches thought to occur secondary to melanocyte dysfunction and loss. it is the most common depigmentation disorder, affecting approximately 0.5 to 2.0 percent of the population and has no predilection for gender or race .
详细描述
Vitiligo is primarily a clinical diagnosis without the need for diagnostic tools. It classified into three types: segmental vitiligo , nonsegmental vitiligo , and unclassifiable vitiligo .
Onset and disease course may vary by subtype .Although the disease is typically asymptomatic and non-fatal; the profound cosmetic disfigurement it produces has a significant negative impact on the patient's quality of life .
Vitiligo occurs due to a complex interaction among genetic, environmental and immunologic factors. This ultimately leads to melanocyte damage resulting characteristic depigmented lesions.
Conventional vitiligo treatments include topical steroid, topical and oral immunomodulators and phototherapy. In spite of much advancement in pharmacotherapy, treatment for vitiligo still remains a challenge for physicians. Re-pigmentation of the lesions on the extremities or over bony prominences is particularly poor due to the reduced numbers of follicle-based melanocytes in these areas .
Treatment of vitiligo with narrowband ultraviolet B light is an important component of the current standard of care.Narrowband ultraviolet B therapy or topical corticosteroid has long been used in vitiligo. However, the re-pigmentation is always transient and time-consuming .
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age ≥ 14 years old.
排除标准
- •Patients less than 14 years old.
- •Patients with new, spreading lesions of vitiligo within the preceding 6 months.
- •Pregnant female patients.
- •Patients with history of keloid formation.
研究组 & 干预措施
Fractional co2 laser&topical steroid
participant will be compared with one side of the body to the ather side.
Intervention:
-Procedure: Fractional carbon dioxide laser.
-Drug: Topical corticosteroid.
-Radiation: Ultraviolet B narrow band.
干预措施: fractional carbon dioxide(CO2) laser (Procedure)
Fractional co2 laser&topical steroid
participant will be compared with one side of the body to the ather side.
Intervention:
-Procedure: Fractional carbon dioxide laser.
-Drug: Topical corticosteroid.
-Radiation: Ultraviolet B narrow band.
干预措施: Topical corticosteroid (Drug)
Fractional co2 laser&topical steroid
participant will be compared with one side of the body to the ather side.
Intervention:
-Procedure: Fractional carbon dioxide laser.
-Drug: Topical corticosteroid.
-Radiation: Ultraviolet B narrow band.
干预措施: Ultraviolet B narrow band (Radiation)
结局指标
主要结局
VASI scor-Vitiligo Area and Severity Index:
时间窗: 4 months
Vitiligo Area and Severity Index (VASI) One hand unit ,which encompasses the palm plus the volar surface of all the digits,is approximately 1% of the total body surface area and is used as a guide to estimate the baseline percentage of vitiligo involvement in each body region.The body is divided into five separate and mutually exclusive regions: hands ,upper extremities (excluding hands),trunk,lower extremities(excluding feet),and feet.The axillary region is included with the upper extremities while the buttocks and inguinal areas are included with the lower extremities.The extent of residual depigmentation is expressed by the following percentages:0,10%,25%,50%,75%,90%,or100%.At 100% depigmentation,no pigment is present; at 90%,specks of pigment is present; at75%,the depigmented area exceeds the pigmented area; at50%,the depigmented and pigmented area are equal; at 25%,the pigmented area exceeds the depigmented area; at10% only specks of depigmentation are present.
次要结局
- Scoring system of repigmentation(4 months)
- Patient satisfaction(4 months)
研究者
MUAAhmed
principal investigator
Assiut University