Evaluation of the role of immunomodulators in combination with Non-cultured epidermal cell suspension in the management of vitiligo- A quasi randomised controlled clinical trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- 1)Repigmentation:
研究概览
简要总结
After proper history and clinical examination , patients with more than 3 months of patch stability (denovo/induced stability ) will be included. All patients recruited will be divided in to two groups, Group 1 and Group 2 . In Group 1 patients with denovo stability will be randomly allocated in to two groups , Group 1a and Group 1b .In group 1a patients will be undergoing NCES vitiligo surgery. In group 1b patients will be undergoing NCES vitiligo surgery and will be given by oral mini pulse of steroid over 12 weeks .In Group 2 patients with induced stability will be undergoing NCES and the immunomodulators will be gradually tapered off over 12 weeks .All patients will be followed up for 6 months of post operative period. Appropriate topical treatment and sun exposure will be continued in post operative period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •More than 3 months of patch stability (spontaneous or therapy induced) 2) Subjects with non-segmental /segmental vitiligo 3) Age ≥15 years.
排除标准
- •Unstable for last 3 months
- •Universal vitiligo or exclusive involvement of tip of finger, toes or palmo plantar or genitalia
- •Vitiligo Patch size more than 100 cm2size
- •Pregnancy or lactation
- •Patients with bleeding diathesis or keloidal tendencies
- •Any known hypersensitivities or contraindication to immunomodulators or local anesthesia
- •Presence of any of the following : Immunocompromised patient, malignancy, co-morbidities like uncontrolled diabetes, chronic renal disease, chronic kidney disease.
结局指标
主要结局
1)Repigmentation:
时间窗: At baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks.
a. Objective – Investigator global assessment (IGA)
时间窗: At baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks.
Vitiligo area severity index (VASI),
时间窗: At baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks.
Colour match, pattern of repigmentation,
时间窗: At baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks.
Dermoscopic assessment (BPLeFoSK criteria)
时间窗: At baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks.
b. Subjective - Patient global assessment (PGA)
时间窗: At baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks.
2)Investigator Global Assessment (IGA)
时间窗: At baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks.
Patient Global Assessment (PGA)
时间窗: At baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks.
次要结局
- 1 Side effects will be noted(2 VIS-22 score assessment for quality of life)