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

Primary Purpose

Vitiligo

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
microneedling and Platelet rich plasma
NB-UVB phototherapy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Assiut university

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

microneedling,NB-UVB with & without PRP

Arm Description

Each participant will be compared with one side of the body to the other side Intervention: Combination Product: microneedling and Platelet rich plasma. radiation : NB-UVB phototherapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

scoring system of repigmentation
G0, < 25% repigmentation (poor) G1, 25-50% repigmentation (fair) G2, 50-75% repigmentation (good) G3 > 75% repigmentation (excellent).
Patients satisfaction
The patient overall satisfaction will be assessed according to Overall satisfaction: dissatisfied neutral somewhat satisfied moderately satisfied very satisfied

Full Information

First Posted
May 11, 2017
Last Updated
July 4, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03155698
Brief Title
Treatment of Acral Vitiligo : Narrowband Ultraviolet-B and Microneedling With and Without Platelet Rich Plasma
Official Title
Treatment of Acral Vitiligo : Narrowband Ultraviolet-B and Microneedling With and Without Platelet Rich Plasma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2021 (Anticipated)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Enrolled subjects will be randomized to treatment with microneedling by using dermapen every two weeks while the contralateral side of the body will be treated by microneedling plus topical PRP every two weeks .Then both sides of the body will receive narrowband UVB twice weekly for 6 month,
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
microneedling,NB-UVB with & without PRP
Arm Type
Experimental
Arm Description
Each participant will be compared with one side of the body to the other side Intervention: Combination Product: microneedling and Platelet rich plasma. radiation : NB-UVB phototherapy
Intervention Type
Combination Product
Intervention Name(s)
microneedling and Platelet rich plasma
Other Intervention Name(s)
dermapen+ topical PRP
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
NB-UVB phototherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
VASI score-Vitiligo Area and Severity Index
Description
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
Time Frame
within 6 months
Secondary Outcome Measure Information:
Title
scoring system of repigmentation
Description
G0, < 25% repigmentation (poor) G1, 25-50% repigmentation (fair) G2, 50-75% repigmentation (good) G3 > 75% repigmentation (excellent).
Time Frame
assessed 6 months following application of intervention
Title
Patients satisfaction
Description
The patient overall satisfaction will be assessed according to Overall satisfaction: dissatisfied neutral somewhat satisfied moderately satisfied very satisfied
Time Frame
within 6months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nagwa Essa Abd EL-Azim, MD
Phone
01280994337
Email
nagwaeasa@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yasmin Mostafa Tawfik, MD
Phone
01006033331
Email
dr.yasminmostawfik@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lamiaa Ahmad Abd El-khalek
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25596811
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.
Results Reference
result
PubMed Identifier
25269389
Citation
Kruger 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.
Results Reference
result
PubMed Identifier
12410698
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. doi: 10.1046/j.1365-2133.2002.04837.x.
Results Reference
result
PubMed Identifier
20197747
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.
Results Reference
result
PubMed Identifier
9420536
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.
Results Reference
result
PubMed Identifier
23919018
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.
Results Reference
result
PubMed Identifier
19481375
Citation
Kaux JF, Le Goff C, Seidel L, Peters 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. French.
Results Reference
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PubMed Identifier
20413357
Citation
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. doi: 10.1016/j.bjps.2010.03.038. Epub 2010 Apr 21.
Results Reference
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PubMed Identifier
25213385
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.
Results Reference
result
PubMed Identifier
12516826
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.
Results Reference
result

Learn more about this trial

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

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