RANDOMISED CONTROLLED STUDY OF EFFICACY OF NCORSHFS (NON-CULTURED EXTRACTED OUTER ROOT SHEATH HAIR FOLLICLE CELLULAR SUSPENSION) VERSUS NCES (NON-CULTURED EPIDERMAL SUSPENSION) IN STABLE VITILIGO
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- To compare the efficacy of 2 surgical procedures i.e. NCORSHFS (Non-cultured extracted
研究概览
简要总结
Vitiligo is an acquired pigmentation disorder manifesting as depigmented lesions
predominantly affecting, skin and mucous membranes due to the loss of melanocytes.1 This
causes significant psychological impact and social stigma among affected individuals.
Researchers are always trying to develop newer modalities of treatment.[2, 3]
Medical treatments like topical steroids, calcineurin inhibitors, and phototherapy are tried as
the first line of treatment but in many cases, optimal results are not achieved.1 Later many
surgical modalities were developed to treat stable vitiligo which included tissue graft (punch,
blister, and split skin grafts) and cellular suspension (melanocyte keratinocyte suspension)
etc.1
Surgical modalities are considered for lesions refractory to medical treatment and non-hairy
sites like lips, and nipple areola complex where repigmentation will be unsatisfactory. NCES
(Non-cultured epidermal suspension). has become a popular surgical modality for stable
vitiligo as it can repigment maximum area compared to all other methods with 1: 10 donorrecipient
ratio, and gives exceptional color matching.[2, 4]
Newer techniques like NCORSHFS (Non-cultured extracted outer root sheath hair follicle
cellular suspension) are emerging, considering hair follicles have a rich source of melanocytes.2
Follicular melanocytes are dendritic and with larger melanosomes compared to those in the
epidermis. The ratio between melanocyte and keratinocyte is 1:6 in the hair follicle whereas it
is 1:36 in the epidermis. This method gives satisfactory repigmentation with excellent color
match.2 Also other advantages are technically less challenging, not requiring mechanical
separation of the epidermis from the underlying dermis, relatively safer, and minimal donor
site complications compared to NCES makes NCORSHFS a useful alternative surgical
modality in the treatment of stable vitiligo.4 There are very few studies comparing the efficacy
of NCORSHFS versus NCES in literature as this technique is relatively new.
Many studies have shown the comparative better efficacy of epidermal cell suspension (NCES)
over NCORSHFS (Non-cultured extracted outer root sheath hair follicle cellular suspension).
Our study will assess the comparative efficacy and side effects of NCORSHFS versus NCES
in the treatment of stable vitiligo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •Age more than 18 years No disease activity for the past 6 months.
- •Not responding to any medical treatmentT.
排除标准
- •Patient with a history of koebnerization.
- •Lesion exclusively over the bony prominence, over the genital and oral mucosa.
- •Patient with keloidal tendency.
- •Patient with a bleeding disorder history.Patient having an active infection at the local site.
- •Pregnancy, lactation, and serious medical illness.
结局指标
主要结局
To compare the efficacy of 2 surgical procedures i.e. NCORSHFS (Non-cultured extracted
时间窗: Baseline,6 months of follow-up
outer root sheath hair follicle cellular suspension) versus NCES (Non-cultured epidermal
时间窗: Baseline,6 months of follow-up
suspension) in the treatment of stable vitiligo at 6 months of follow-up
时间窗: Baseline,6 months of follow-up
次要结局
- To find out the complication rate between two groups(2. To find out the mean duration to achieve 50% repigmentation in both groups at every month)
研究者
Dr Revathi S
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry