Efficacy and safety of combined oral cyclosporine and autologous noncultured melanocyte keratinocyte transplantation procedure (NCES) versus only NCES for stable vitiligo: A double-blinded placebo-controlled pilot adaptive randomization trial using minimization
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To analyse the efficacy and safety of combined NCES with cyclosporine in comparison to NCES alone as measured baseline and at end of 6 months
研究概览
简要总结
Vitiligo is an acquired depigmentation disorder characterized by depigmented lesions resulting from autoimmune destruction of melanocytes. It has a major impact on the quality of life of patients due to low self-esteem esteem and social isolation.
Medical treatments like topical steroids, calcineurin inhibitors, and phototherapy are tried during the active stage of the disease, but in most cases, optimal results are not achieved. Lesions in acral and non hairy regions are often resistant to treatment. Surgical treatment is helpful in such resistant areas and in residual lesions.
Melanocytes can be introduced by cellular or tissue grafts. Surgical treatment including tissue graft (punch, blister and split skin grafts) and cellular suspension (of cultured or non cultured cells melanocyte keratinocyte suspension) are used to treat stable vitiligo which are refractory to medical treatment. Melanocyte keratinocyte suspension has become popular surgical modality of vitiligo treatment as it can repigment maximum area compared to tissue grafts. However, loss of pigmentation and relapse occurs in few patients.
While vitiligo surgery provides good results in majority of patients, some lesions fail to repigment or lose achieved pigmentation. It usually manifests as a depigmented halo around the treated area(perilesional halo/achromic fissure). This is supposed to be due to cytotoxic CD8+ T cells in the perilesional skin. Cyclosporine is an immunomodulator that acts on Tcells .In this study we are going to compare the outcome after NCES in terms of extent and quality of repigmentation in two groups with and without cyclosporine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.age more than 18 years 2.patients who are willing to come for 1 year 3.clinically stable vitiligo with vitiligo disease activity score (VIDA) of less than 0 4.vitiligo signs of activity score (VSAS) less than 2.
排除标准
- •1.Patient with contraindications for cyclosporine 2.Uncontrolled hypertension 3.Hypersensitivity to cyclosporine 4.Deranged baseline renal parameters 5.Concomitant use of other nephrotoxic drugs 6.Deranged baseline liver function tests 7.Tuberculosis 8.Immunosuppressed individuals 9.Refractory hyperkalemia, hyperuricemia, hypomagnesemia 10.Pregnancy, lactation and serious medical illness 11.Patient with past or current history of malignancy.
结局指标
主要结局
To analyse the efficacy and safety of combined NCES with cyclosporine in comparison to NCES alone as measured baseline and at end of 6 months
时间窗: Baseline,6 months
1.Morphometry - Extent (surface area) of repigmentation in percentage measured by analysis of images taken through DSLR camera using ImageJ software
时间窗: Baseline,6 months
2.To compare the quality of repigmentation between the NCES + cyclosporine group and the NCES alone group using a semiquantitative colour match scale, assessed by two independent dermatologists based on standardized clinical photographs.
时间窗: Baseline,6 months
3.Safety- To assess the incidence and severity of adverse effects in each group at each visit.
时间窗: Baseline,6 months
次要结局
- 1)To establish a correlation between baseline lesional CD8+ infiltrate and postoperative outcome in terms of percentage of repigmentation(2)proportion of patients with successful repigmentation)
研究者
Dr A Swaroopa
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry