Clinical trial NCT03872804: Punch Minigraft Versus Transverse Needling or Combination of Both in Treatment of Non-Segmental Vitiligo
Official title: Punch Minigraft Versus Transverse Needling or Combination of Both in Treatment of Non-Segmental Vitiligo
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vitiligo
Keywords: Vitiligo
Punch graft
Oral pulse steroid
Transverse needling
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of repigmentation
timeFrame: 6 months
measure: Evaluation of Type, pattern and extent of repigmentation.
timeFrame: 6 months
measure: Digital assessment of the size of the lesion and of the depigmented versus repigmented area
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Omneya abd el aziz el zagh
Study officials:
affiliation: Assistant Professor of dermatolog Faculty of Medicine. University of Alexandria.
name: Carmen Ibrahiem farid amin, Ph.D
role: STUDY_DIRECTOR
affiliation: Professor of Dermatlolgy, Faculty of Medicine. University of Alexandria.
name: Magdy Abd el aziz ragab, Ph.D
role: STUDY_DIRECTOR
References: