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

Not Applicable

• Conditions: Vitiligo
• Interventions: Procedure: Transverse needling; Procedure: Punch minigrafts followed by transverse needling; Other: Oral pulse steroid with narrow band

• Registration Number: NCT03872804
• Lead Sponsor: Alexandria University

Brief 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.

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-03-06
• Study First Submitted QC: 2019-03-11
• Study First Posted: 2019-03-13
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-14
• Last Update Posted: 2021-01-19
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Adult patients (>16 years old) of either gender having stable non segmental vitiligo, that is resistant to other lines of repigmentation therapy.
• Lack of progression of old lesions with the past 6 months.
• No development of new lesions
• Absence of history of koebner phenomenon.
• Absence of confetti lesions or hypopigmented lesions within the past 6 months.
• Presence of repigmentation of depigmented areas by medications or spontaneously in the past 6 months.
• While resistance to therapy will be judged after receiving standard protocol of NB-UVB together with oral mini pulse dexamethasone at a dose of 2.5 mg on two consecutive weekly days for 3 months.
• Patients having lesions showing absence or poor repigmentation after this regiment will be considered resistant to medical repigmentation and indicated to surgery.

Exclusion Criteria

• Cases of active, progressive disease lacking criteria of stability previously mentioned.
• Patients with segmental or universal vitiligo covering more than 70% body surface area.
• Patients with known associated autoimmune diseases, bleeding tendency, current or history of skin neoplasia, photosensitive disorders or any contraindications to corticosteroids therapy.
• Patients with tendency towards hypertrophic scars or keloid formation.
• Pregnant female and lactating mothers.
• Patients with emotional and psychological instability.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitiligo patient	Punch minigrafts followed by transverse needling	Patient has at least 4 patches , one of them will be treated by autologous punch graft , second one by transverse needling , third one with minigraft followed by needling , fourth one as control under treatment with oral pulse steroid with narrow band .
Vitiligo patient	Oral pulse steroid with narrow band	Patient has at least 4 patches , one of them will be treated by autologous punch graft , second one by transverse needling , third one with minigraft followed by needling , fourth one as control under treatment with oral pulse steroid with narrow band .
Vitiligo patient	Transverse needling	Patient has at least 4 patches , one of them will be treated by autologous punch graft , second one by transverse needling , third one with minigraft followed by needling , fourth one as control under treatment with oral pulse steroid with narrow band .

Primary Outcome Measures

Name	Time	Method
Evaluation of Type, pattern and extent of repigmentation.	6 months	Serial photography will be done to evaluate type, pattern and extent of repigmentation.
Assessment of repigmentation	6 months	Assessments of repigmentation will be performed by two blinded dermatologists using a 5-point scale; grade 0 (no repigmentation), grade 1 (1%-5%), grade 2 (6%-25%), grade 3 (26%-50%), grade 4 (51%-75%) and grade 5 (76%-100%)
Digital assessment of the size of the lesion and of the depigmented versus repigmented area	6 months	Digital assessment of the size of the lesion and of the depigmented versus repigmented area using Adobe photoshop software

Trial Locations

Locations (1)

Omneya abd el aziz el zagh; 🇪🇬 Alexandria, Egypt