Punch Minigraft Versus Transverse Needling or Combination of Both in Treatment of Non-Segmental Vitiligo
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|ClinicalTrials.gov Identifier: NCT03872804|
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : September 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Vitiligo||Procedure: Autologous punch mini grafts: Procedure: Transverse needling Procedure: Punch minigrafts followed by transverse needling Other: Oral pulse steroid with narrow band||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Punch Minigraft Versus Transverse Needling or Combination of Both in Treatment of Non-Segmental Vitiligo|
|Actual Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||August 1, 2020|
|Estimated Study Completion Date :||August 1, 2020|
Experimental: Vitiligo patient
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 .
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
- Assessment of repigmentation [ Time Frame: 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%)
- Evaluation of Type, pattern and extent of repigmentation. [ Time Frame: 6 months ]Serial photography will be done to evaluate type, pattern and extent of repigmentation.
- Digital assessment of the size of the lesion and of the depigmented versus repigmented area [ Time Frame: 6 months ]Digital assessment of the size of the lesion and of the depigmented versus repigmented area using Adobe photoshop software
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872804
|Contact: Omneya El zagh, MBBCh||+201142955011||Dr.firstname.lastname@example.org|
|Omneya abd el aziz el zagh||Recruiting|
|Alexandria, Egypt, 21500|
|Contact: Omneya El zagh +201142955011 Dr.email@example.com|
|Principal Investigator: Carmen Farid amin, Professor|
|Study Director:||Carmen Ibrahiem farid amin, Ph.D||Assistant Professor of dermatolog Faculty of Medicine. University of Alexandria.|
|Study Director:||Magdy Abd el aziz ragab, Ph.D||Professor of Dermatlolgy, Faculty of Medicine. University of Alexandria.|