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

Alexandria University

Status: Unknown

Conditions: Vitiligo

Treatments: Procedure: Transverse needling; Procedure: Autologous punch mini grafts:; Other: Oral pulse steroid with narrow band; Procedure: Punch minigrafts followed by transverse needling

Study type: Interventional

Funder types: Other

Identifiers

NCT03872804

AlexandriadermaU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Vitiligo patient

Experimental group

Description:

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 .

Treatment:

Other: Oral pulse steroid with narrow band

Procedure: Transverse needling

Procedure: Autologous punch mini grafts:

Procedure: Punch minigrafts followed by transverse needling