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

NCT03155698 | Unknown

• 1 other identifier: TOAV
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• scoring system of repigmentation

  assessed 6 months following application of intervention

• Patients satisfaction

  within 6months

Study Arms (1)

microneedling,NB-UVB with & without PRP

EXPERIMENTAL

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

Combination Product: microneedling and Platelet rich plasma; Radiation: NB-UVB phototherapy

Interventions

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. * 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.

Also known as: dermapen+ topical PRP

microneedling,NB-UVB with & without PRP

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

microneedling,NB-UVB with & without PRP

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, Egypt

Location

Related Publications (10)

• 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.

  PMID: 25596811 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.

  PMID: 25269389 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.

  PMID: 12410698 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.

  PMID: 20197747 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.

  PMID: 9420536 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.

  PMID: 23919018 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.

  PMID: 19481375 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.

  PMID: 20413357 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.

  PMID: 25213385 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.

  PMID: 12516826 RESULT

MeSH Terms

Conditions

Vitiligo

Interventions

Percutaneous Collagen Induction

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Officials

• Lamiaa Ahmad Abd El-khalek

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nagwa Essa Abd EL-Azim, MD

CONTACT

01280994337; nagwaeasa@yahoo.com

Yasmin Mostafa Tawfik, MD

CONTACT

01006033331; dr.yasminmostawfik@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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,

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 16, 2017
• Study Start: August 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 7, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)