A 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

Phase 2/3

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2022/02/040232

Lead Sponsor: PGIMER

Brief Summary: 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 Manekshawâ€™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 usingManekshawâ€™s dermabrader in repigmentation rates following non-cultured epidermal cell suspension.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

1)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.
3)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.
4)Disease should have failed repigmentation with medical treatment, or there are residual patches (after medical therapy) of vitiligo.
5)Size of vitiligo patches <100cm2.
6)Wash off period of 4 weeks for topical therapy and 12 weeks for systemic therapy has passed.

Exclusion Criteria

1)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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1): PGIMER
🇮🇳
Chandigarh, CHANDIGARH, India
PGIMER
🇮🇳Chandigarh, CHANDIGARH, India
AKSHAY MEENA
Principal investigator
09003989552
akshaymeena669@gmail.com