Puncture to Repigment: A Comparative Analysis Of Needling vs. Microneedling Along With NBUVB in Treatment of Non-Segmental Vitiligo
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Treatment efficacy
研究概览
简要总结
This randomized controlled trial aims to compare the efficacy of needling versus microneedling, both followed by narrowband UVB therapy, in achieving repigmentation in patients with localized stable non-segmental vitiligo.
详细描述
The study will enroll 80 patients aged 15-60 years with localized stable vitiligo. Participants will be randomized into two groups: one receiving needling and the other microneedling, each followed by NBUVB therapy. The primary outcome is the percentage of repigmentation at 12 weeks, assessed through digital planimetry and standardized clinical photography. Secondary outcomes include adverse effects such as erythema, post-inflammatory hyperpigmentation, infection, and scarring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both male and female
- •Age 15-60 years
- •Patients having vitiligo for more than 1 year
排除标准
- •Patients with tendency of keloid formation or hypertrophic scarring
- •Patients with any bleeding disorder, coagulation defect or using anti platelets
- •Any local infection at the treatment site
- •Patients who had received systemic therapy in last 6 months
研究组 & 干预措施
Microneedling + NBUVB(Group B)
干预措施: Needling + NBUVB (Procedure)
Needling + NBUVB(Group A)
干预措施: Microneedling + NBUVB (Procedure)
结局指标
主要结局
Treatment efficacy
时间窗: 12 weeks
Efficacy will be assessed at 12 weeks using the Physician's Global Assessment Scale. Improvement is defined as ≥25% repigmentation of vitiliginous patches, measured via digital planimetry and standardized clinical photography. The higher the score, the more effective is the treatment modality. 0-25% re pigmentation= Mildimprovement 25-50% re pigmentation= Moderate improvement 51-75% re pigmentation= Good 76-100% re pigmentation= Excellent to complete
Treatment efficacy
时间窗: 12 weeks
Efficacy will be assessed at 12 weeks using the Physician's Global Assessment Scale. Improvement is defined as ≥25% repigmentation of vitiliginous patches, measured via digital planimetry and standardized clinical photography. The higher the score, the more effective is the treatment modality. 0-25% re pigmentation= Mildimprovement 25-50% re pigmentation= Moderate improvement 51-75% re pigmentation= Good 76-100% re pigmentation= Excellent to complete
次要结局
- Adverse effects(12 weeks)
研究者
Huma Gul
DOCTOR
Khyber Teaching Hospital