跳至主要内容
临床试验/CTRI/2022/02/040232
CTRI/2022/02/040232尚未招募2/3 期

A COMPARATIVE STUDY BETWEEN RECEPIENT SITE PREPARATION USING MANUAL DERMABRASION AND TATTOOING PEN IN AUTOLOGOUS NON CULTURED EPIDERMAL CELL SUSPENSION PROCEDURE IN STABLE VITILIGO PATIENTS: A RANDOMIZED DOUBLE BLINDED STUDY

PGIMER1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年2月25日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
PGIMER
入组人数
30
试验地点
1
主要终点
1.The proportion of patients achieving 75% repigmentation at 24 weeks follow-up in both groups.

研究概览

简要总结

Vitiligo is acommon acquired disorder of depigmentation which occurs as a result ofmelanocyte loss.  While the prevalence ofvitiligo around the globe is around 1%, the prevalence in India goes up to8.8%, making it a major proportion of patients seen in dermatology services.1The dark complexion of a considerable size of our population combined withsocial stigma and lack of knowledge about the disease in the general populationcauses a lot of psychological distress to the patients.

Vitiligo ischaracterized by milky or ivory white sharply demarcated macules, oftensymmetrical on both sides of the body. The size of the lesions may vary from a few millimetres to severalcentimetres.   The common sites ofpredilection are areas of repeated trauma or chronic pressure or friction likehips, dorsum of hands and feet, ankles, elbows and knees. The natural course ofthe disease is highly unpredictable as well, with periods of abrupt onset,active disease, then stability or repigmentation and rapid progression after aperiod of dormancy.

Many theorieshave been suggested for the etiopathogenesis of vitiligo: genetic, biochemical,neural, autoimmune, defective free radical defence, deficiency of melanocytegrowth factors and an intrinsic defect of melanocyte adhesion.2In spite of this, vitiligo still remains an idiopathic disorder, with more thanone factor at play in a single individual. It is also associated with a myriadof autoimmune diseases with the most common one being thyroid disorders.

The cosmeticdisfigurement combined with the social stigma and lack of a uniformly effectivetherapy calls for the development of newer and better treatment modalities.Conventional medical therapies have used both topical and oral treatment. Firstline therapies are usually topical steroids or topical calcineurin inhibitors liketacrolimus and pimecrolimus, combined with ample and regular use of sunscreen.3Oral mini pulse therapy using dexamethasone is used for rapidly progressive or activedisease and has shown to halt the disease activity and has causedrepigmentation in some patients.3Other therapies like antioxidants, systemic phototherapy i.e. psoralen andultraviolet A (PUVA), ultraviolet B (UVB) therapy, laser therapy are also beingused.3Response to these therapies, both conventional and novel, is variable inindividuals, often giving unsatisfactory results, especially in those withacral lesions, with patients having to resort to cosmetic camouflage.

Surgicaltherapies are indicated in patients with stable disease who fail to respond tomedical therapies. This mostly includes autologous grafting techniques bothtissue and cellular (both cultured and non-cultured).4Cellular grafting techniques generally involve harvesting epithelial cells fromthe donor sites and after proper preparation grafting them onto the recipientsites with the aim of repopulating the depigmented area with melanocytes tocause repigmentation.4Recipient site preparation is needed to stimulate melanogenesis and melanocyteproliferation. This step is crucial in determining the success of theprocedure, hence making it essential to study the various methods and knowabout their efficacies. Common techniques of recipient site preparation includedermabrasion, suction blistering, liquid nitrogen, electrofulguration,microneedlig etc.5Recipient site preparation using dermabrasion is one of the most widely used methods and includesmanual dermabrasion using Manekshaw’s dermabrader and motor dermabrasion. Manual dermabrasion is thegold standard technique and is the standard of care followed in most centres.

Microneedlingwas initially introduced for skin rejuvenation, however, this minimallyinvasive procedure is now being used for the treatment of multiple dermatologicalconditions. It is better than simple injection needle in controlling depth ofpenetration and thus preventing excessive pain during injection.

It causes amicro-inflammation in the epidermal layer which enhances melanocytes andkeratinocytes migration and stimulates repigmentation of vitiligo areas. Wepropose to compare the outcome of microneedling assisted recipient sitepreparation with the technique of conventional manual dermabrasion usingManekshaw’s dermabrader in repigmentation rates following non-cultured epidermal cell suspension.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients with a clinical diagnosis of segmental or non-segmental vitiligo and 2)Patients with two independent patches of size 3x3 cm or more present either symmetrically or unilaterally over same body site or patients with a single patch of 6 x 6 cm or more.
  • Vitiligo lesions have been stable for 1 year or more.
  • Stability is defined as no progression of lesions for at least 1 year or more, with or without spontaneous repigmentation and absence of new koebner phenomenon.
  • Disease should have failed repigmentation with medical treatment, or there are residual patches (after medical therapy) of vitiligo.
  • Size of vitiligo patches <100cm
  • Wash off period of 4 weeks for topical therapy and 12 weeks for systemic therapy has passed.

排除标准

  • Pregnancy and lactation 2)Patient with active disease i.e. VIDA 1+ or more 3)History of hypertrophic scars or keloidal tendency 4)Current skin infections at donor or recipient site 5) Patients with unrealistic expectations 6) History of bleeding disorders 7) Patients on anticoagulants 8) Immunosuppressed patients.

结局指标

主要结局

1.The proportion of patients achieving 75% repigmentation at 24 weeks follow-up in both groups.

时间窗: 24 weeks

次要结局

  • 1.The proportion of patients achieving 50% repigmentation at 24 weeks follow-up in both groups.(2.To assess the color matching of repigmented area.)

研究者

发起方
PGIMER
申办方类型
Research institution and hospital

研究点 (1)

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