NCT03872804

Punch Minigraft Versus Transverse Needling or Combination of Both in Treatment of Non-Segmental Vitiligo

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the effectiveness and tolerability of autologous punch minigraft, transverse needling technique or combination of both followed by narrow band ultraviolet B phototherapy (311 nm) in the treatment of patients with stable non-segmental vitiligo lesions.

Detailed description

Vitiligo is a common pigmentary cutaneous disorder occurring with an incidence of 1-2% worldwide, without predilection for sex or race. The disease is characterized by gradual loss of the normal color of the skin resulting from melanin pigment loss due to the underlying destruction of the melanocyte. Vitiligo is a multifactorial disorder with many theories explaining its pathogenesis such as autoimmunity, self-destructing mechanisms,neural mediators, biochemicals,an imbalance of epidermal cytokines and genetic factors. Vitiligo is not a life-threatening disease,but it may cause a major social and emotional distress with significant impairment in the quality of life. Clinically; vitiligo is classified into segmental, non-segmental and unclassified vitiligo .Non-segmental includes generalized, acrofacial,universal, mucosal (more than one mucosal site) , mixed (associated with segmental vitiligo) and other rare variants. Segmental vitiligo includes uni- ,bi- or pluri-segmental subtypes. Unclassified includes focal or mucosal (one site) subtypes. Treatment options for vitiligo include attempting repigmentation of affected areas, depigmentation of non-involving skin or camouflage if neither is effective.Repigmentation could be attempted using medical therapy, surgical modalities. Topical medications include corticosteroids or calcineurin inhibitors.Ultraviolet radiation therapy, such as narrow-band ultraviolet B light (NB-UVB), is also widely used. It is minimally invasive, has few adverse effects and provides a good response rate. Excimer laser or light has become available for use recently, and favorable treatment results have been reported. When medical treatments are ineffective, surgical treatment is indicated.

Conditions

• Vitiligo

Interventions

Type	Name	Description
PROCEDURE	Autologous punch mini grafts:	Under local anesthesia, multiple 1mm holes will be made in the depigmented treatment area using 1mm punch graft instrument inserted to a depth of 2-4 mm to remove a small column of depigmented skin that is to be discarded. The punches will be situated at or very close to the border of the lesion to avoid leaving an achromic fissure and will be separated by 5-8 mm distance from each other. On the donor area mostly is the gluteal area, punches will be harvested using the same sized punches very close to each other so that maximum number of grafts can be taken from a small area. Then the harvested-punch minigrafts will be inserted into the recipient chambers, pressed firmly by saline soaked gauge for hemostasis and secured by sterile strips or a compression bandage if applicable.
PROCEDURE	Transverse needling	Needling will be done for selected treatment patch using a 30 G disposable insulin syringe, going from the pigmented margins of the lesion into the vitiliginous patch, Position of the needle will be kept close to the dermoepidermal junction and movement will be from normal skin towards the lesion. Needle pricks may lead to oozing of a small drop of blood which will be managed by physical pressure. No dressings will be needed. The procedure will be repeated for selected lesions weekly for a duration of 3 months.
PROCEDURE	Punch minigrafts followed by transverse needling	In a third lesion, punch minigrafts will be done as mentioned in line 1 and will be left to stabilize for 3 months then transverse needling will be done weekly for the margins of the lesion as well as the areas of the punch grafts toward the vitiliginous area.
OTHER	Oral pulse steroid with narrow band	* A fourth lesion will be chosen as a control lesion, to which no surgical treatment will ba attempted. * All lesions will receive NB-UVB therapy according to standard protocol twice weekly and the patients will continue on the oral mini pulse dexamethasone at 2.5 mg dose for two consecutive days weekly all through the study period

Timeline

• Start date: 2019-02-01
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2019-03-13
• Last updated: 2021-01-19

Locations

1 site across 1 country: Egypt