Treatment of Acral Vitiligo : Narrowband Ultraviolet-B and Microneedling With and Without Platelet Rich Plasma

Vitiligo Clinical Trial

Official title:

Treatment of Acral Vitiligo : Narrowband Ultraviolet-B and Microneedling With and Without Platelet Rich Plasma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03155698
• Other study ID #: TOAV
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2021
• Est. completion date: December 2021

Study information

• Verified date: July 2021
• Source: Assiut University
• Contact: Nagwa Essa Abd EL-Azim, MD
• Phone: 01280994337
• Email: nagwaeasa[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Vitiligo is a relatively common acquired chronic disorder of pigmentation characterized by the development of white macules on the skin due to loss of epidermal melanocytes .Affecting approximately 0.5%-2% of general population worldwide, without predilection for sex or race.

Description:

Lesions may occur in a localized or generalized distribution and may coalesce into large, depigmented areas. Given the contrast between the white areas and normal skin, the disease is most disfiguring in darker skin types and has a profound impact on the quality of life of both children and adults. Generalized vitiligo is the most common clinical presentation and often involves the face and acral regions. The acral and joint areas are common sites of occurrence of vitiliginous lesions, because they are areas subjected to repeated trauma or irritation . The acral lesions are more visible and cosmetically important than lesions at many other sites, causing greater psychosocial distress Acral lesions are usually more resistant to medical management . Several reasons have been put forward, including relatively low melanocyte density; minimal density of hair follicles, which are a melanocyte reservoir; and a greater chance of repeated friction or trauma, which can induce koebnerization. Both acral and joint lesions also tend to be resistant to surgical management . The narrow band-ultraviolet B phototherapy is considered to be a very important modality in vitiligo treatment since its first use in 1997. It was proved to be of higher efficacy, better tolerated, and superior to the other lines of treatment . The prolonged duration of narrow band-ultraviolet B therapy is the main reason for noncompliance, distance to be traveled and monetary, and time loss in attending the hospital at least twice a week for prolonged time were cited as the second common cause for attrition. This clearly increases the need for combined therapy with narrow band-ultraviolet B (NB-UVB) to shorten the duration.

Combined treatments have been found to be superior to monotherapies regarding efficacy, early response and safety, especially in difficult to treat areas and refractory cases .

Platelet-rich plasma (PRP) is an autologous preparation of platelets in concentrated plasma.

Various growth factors, including platelet-derived growth factor, transforming growth factor, vascular endothelial growth factor, and insulin-like growth factor, are secreted from α-granules of concentrated platelets activated by aggregation inducers .

The beneficial effect of platelet rich plasma in vitiligo could be suggested through these growth factors which stimulate keratinocytes and fibroblasts proliferation with subsequent improvement of their interaction with melanocytes leading to the stabilization of melanocytes, it was also found that platelet rich plasma treatment induced accelerated proliferation and migration of fibroblasts through up-regulation of cyclin E and Cyclin- dependent kinase 4, which is important in cell migration and proliferation . Skin micro needling is a technique predominantly used to improve the appearance of cutaneous scarring and photo damage, fine needles puncture the skin, resulting in increased dermal elastin and collagen, collagen remodeling, and thickening of the epidermis and dermis . Additionally, skin needling creates small channels, which increase the absorption of topically applied preparations which has been used in various dermatological treatments.

.Aim of the work:

1. To determine efficacy and safety of automated microneedling + topical platelet rich plasma in combination with narrowband- ultraviolet B in treatment of resistant acral vitiligo.

2. To compare the efficacy of automated microneedling + topical Platelet rich plasma in combination with narrowband ultraviolet B versus automated microneedling and narrowband ultraviolet B only in treatment of resistant acral vitiligo.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Patients older than 18 years.

• Patients with bilateral and symmetrical vitiligo acral in distribution.

• Lesions stable for at least three months.

• Patients receiving topical treatment will be required to undergo two weeks washout period.

• Patients receiving systemic treatment will be required to undergo 1 month washout period.

• Patients who were unresponsive to medical treatment or photo therapy.

• No sex predilection

Exclusion Criteria:

• Haemoglobin< 10 g/dl.

• Platelet count < 105 /UL.

• Patients with active infection.

• Reported histories of koebnerization.

• History of keloid formation or hypertrophic scars.

• Pregnant or lactating females.

• Bleeding tendency.

• Patients with chronic liver diseases.

• Patients using systemic chemotherapy, anti-coagulation therapy and antiplatelet agents.

Related Conditions & MeSH terms

• Vitiligo

Intervention

Combination Product:
• microneedling and Platelet rich plasma
Patient's skin is first cleaned with ethyl alcohol. Topical anaesthetic cream is then applied to skin for 30 min. Once anaesthesias is fully developed, Dermapen will be applied on the lesional skin in four direction, vertical, horizontal and the two diagonal until pin point bleeding occur which will be gently massaged. After ten minutes the prepared platelet rich plasma will be applied topically and after about 2 minutes. Occlusive dressing will be done and kept for 1 day then the patient will use topical antibiotic. The procedure will be repeated every 15 days.

Radiation:
• NB-UVB phototherapy
All patients will receive NB-UVB twice weekly for maximum 6 months, starting with a dose of 0.21 J/cm² independent of skin type and increased by 20% every session until we reach the minimal erythema dose

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (10)

Aust MC, Reimers K, Kaplan HM, Stahl F, Repenning C, Scheper T, Jahn S, Schwaiger N, Ipaktchi R, Redeker J, Altintas MA, Vogt PM. Percutaneous collagen induction-regeneration in place of cicatrisation? J Plast Reconstr Aesthet Surg. 2011 Jan;64(1):97-107. — View Citation

Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015 Jul 4;386(9988):74-84. doi: 10.1016/S0140-6736(14)60763-7. Epub 2015 Jan 15. Review. — View Citation

Fabbrocini G, De Vita V, Izzo R, Monfrecola G. The use of skin needling for the delivery of a eutectic mixture of local anesthetics. G Ital Dermatol Venereol. 2014 Oct;149(5):581-5. — View Citation

Gonshor A. Technique for producing platelet-rich plasma and platelet concentrate: background and process. Int J Periodontics Restorative Dent. 2002 Dec;22(6):547-57. — View Citation

Holla AP, Parsad D. Vitiligo surgery: its evolution as a definite treatment in the stable vitiligo. G Ital Dermatol Venereol. 2010 Feb;145(1):79-88. Review. — View Citation

Kandaswamy S, Akhtar N, Ravindran S, Prabhu S, Shenoi SD. Phototherapy in Vitiligo: Assessing the Compliance, Response and Patient's Perception about Disease and Treatment. Indian J Dermatol. 2013 Jul;58(4):325. doi: 10.4103/0019-5154.113944. — View Citation

Kaux JF, Le Goff C, Seidel L, Péters P, Gothot A, Albert A, Crielaard JM. [Comparative study of five techniques of preparation of platelet-rich plasma]. Pathol Biol (Paris). 2011 Jun;59(3):157-60. doi: 10.1016/j.patbio.2009.04.007. Epub 2009 May 28. Frenc — View Citation

Krüger C, Schallreuter KU. Stigmatisation, Avoidance Behaviour and Difficulties in Coping are Common Among Adult Patients with Vitiligo. Acta Derm Venereol. 2015 May;95(5):553-8. doi: 10.2340/00015555-1981. — View Citation

Olsson MJ, Juhlin L. Long-term follow-up of leucoderma patients treated with transplants of autologous cultured melanocytes, ultrathin epidermal sheets and basal cell layer suspension. Br J Dermatol. 2002 Nov;147(5):893-904. — View Citation

Westerhof W, Nieuweboer-Krobotova L. Treatment of vitiligo with UV-B radiation vs topical psoralen plus UV-A. Arch Dermatol. 1997 Dec;133(12):1525-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VASI score-Vitiligo Area and Severity Index	Vitiligo Area and Severity Index (VASI) One hand unit, which encompasses the palm plus the volar surface of all the digits, is approximately 1% of the total body surface area and is used to estimate the baseline percentage of vitiligo involvement in each body region. The body is divided into five separate and mutually exclusive regions: hands, upper extremities (excluding hands), trunk, lower extremities (excluding feet), and feet. The axillary region is included with the upper extremities while the buttocks and inguinal areas are included with the lower extremities. The extent of residual depigmentation is expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. At 100% depigmentation, no pigment is present; at 90%, specks of pigment are present; at 75%, the depigmented area exceeds the pigmented area; at 50%, the depigmented and pigmented areas are equal; at 25%, the pigmented area exceeds the depigmented area; at 10%, only specks of depigmentation	within 6 months
Secondary	scoring system of repigmentation	G0, < 25% repigmentation (poor); G1, 25-50% repigmentation (fair); G2, 50-75% repigmentation (good); G3 > 75% repigmentation (excellent).	assessed 6 months following application of intervention
Secondary	Patients satisfaction	The patient overall satisfaction will be assessed according to Overall satisfaction: dissatisfied; neutral; somewhat satisfied; moderately satisfied; very satisfied	within 6months