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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| microneedling,NB-UVB with & without PRP | Experimental | Each participant will be compared with one side of the body to the other side Intervention:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| microneedling and Platelet rich plasma | Combination Product | 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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| scoring system of repigmentation |
| assessed 6 months following application of intervention |
| Patients satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nagwa Essa Abd EL-Azim, MD | Contact | 01280994337 | nagwaeasa@yahoo.com | |
| Yasmin Mostafa Tawfik, MD | Contact | 01006033331 | dr.yasminmostawfik@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Lamiaa Ahmad Abd El-khalek | Assiut University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut university | Asyut | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25596811 | Result | 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. | |
| 25269389 | Result | 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. |
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000097244 | Percutaneous Collagen Induction |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D011677 | Punctures |
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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,
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| NB-UVB phototherapy | Radiation | 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 |
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The patient overall satisfaction will be assessed according to Overall satisfaction:
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| within 6months |
| 12410698 | Result | 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. |
| 20197747 | Result | 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. |
| 9420536 | Result | 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. |
| 23919018 | Result | 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. |
| 19481375 | Result | 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. |
| 20413357 | Result | 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. |
| 25213385 | Result | 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. |
| 12516826 | Result | 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. |
| D012046 |
| Rehabilitation |