Efficacy of PRP With Er-YAG Laser Versus With Microneedling in Localized Stable Vitiligo

NCT05511493 | Unknown

• 1 other identifier: PRP in vitiligo
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aims of this study are to:- Compare the effect of fractional Erbium: YAG laser assisted delivery of platelet- rich plasma versus microneedling with platelet-rich plasma in the induction of skin repigmentation in localized stable vitiligo patients.

Conditions

Localized Vitiligo

Outcome Measures

Primary Outcomes (1)

• percentage of skin repigmentation of localized stable vitiligo

  according to Physician's Global Assessment \[PGA\] G4 (excellent: \>75% repigmentation) G3 (very good: 50%-75% repigmentation) G2 (good: 25%-50% repigmentation) G1 (satisfactory: \<25% repigmentation) G0 (poor: no repigmentation) The start of color and textural changes of skin will be examined every month. Assessment of pattern of repigmentation as marginal, perifollicular, diffuse and combined .

  six month

Secondary Outcomes (1)

• Response to treatment

  six month

Study Arms (2)

fractional(Er: YAG) laser with platelet-rich plasma

EXPERIMENTAL

Subjected to fractional erbium: yttrium-aluminum-garnet (Er: YAG) laser (FotonaXs * Dynamis, Slovenia) with the energy of 1400 mJ in short pulse mode (SP) with spot size of 7 mm diameter, frequency of 3 Hz, and pixel 1. PRP is applied over the treated areas.This procedure will be repeated every two weeks for six months

Device: fractional Erbium-YAG laser

Microneedling with platelet-rich plasma

EXPERIMENTAL

Subjected to microneedling using electronic dermapen device (Dr Pen Derma Pen Ultima A6®) which has a disposable head that personalized for each patient and sterilized after each session. The derma pen will penetrate the skin with variable depths ranging from 0.25 to 0.5 mm (not more than the depth of the epidermis). It will pass vertically over the vitiligo area in a circular pattern from the perilesional areas toward the depigmented center until pinpoint bleeding appears then the PRP is applied over the treated areas. \- This procedure will be repeated every two weeks for six months.

Device: microneedling

Interventions

fractional Erbium-YAG laser DEVICE

Platelet-rich plasma with fractional Erbium-YAG laser in localized stable vitiligo

fractional(Er: YAG) laser with platelet-rich plasma

microneedling DEVICE

Platelet-rich plasma with microneedling in localized stable vitiligo

Microneedling with platelet-rich plasma

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- 1) Patients of both sexes with stable localized vitiligo: stable patches (should not have any increase or decrease in size or pigmentation for at least 3 months) .
• )Age between 10 - 60 years

You may not qualify if:

• )Acute or chronic infections. 2) Koebner phenomenon. 3) Contraindications to PRP injections:
• Patients with blood or platelet abnormalities.
• Patients taking anti-platelet drugs or anticoagulants.
• Patients with a history of altered or abnormal fibroblast function, such as collagen diseases or myelofibrosis.
• \) We also excluded pregnant or lactating women. 5) All patients included had not received any local or systemic medication for at least 2 months before the study.

Sponsors & Collaborators

• South Valley University: lead

Related Publications (11)

• Jin Y, Andersen G, Yorgov D, Ferrara TM, Ben S, Brownson KM, Holland PJ, Birlea SA, Siebert J, Hartmann A, Lienert A, van Geel N, Lambert J, Luiten RM, Wolkerstorfer A, Wietze van der Veen JP, Bennett DC, Taieb A, Ezzedine K, Kemp EH, Gawkrodger DJ, Weetman AP, Koks S, Prans E, Kingo K, Karelson M, Wallace MR, McCormack WT, Overbeck A, Moretti S, Colucci R, Picardo M, Silverberg NB, Olsson M, Valle Y, Korobko I, Bohm M, Lim HW, Hamzavi I, Zhou L, Mi QS, Fain PR, Santorico SA, Spritz RA. Genome-wide association studies of autoimmune vitiligo identify 23 new risk loci and highlight key pathways and regulatory variants. Nat Genet. 2016 Nov;48(11):1418-1424. doi: 10.1038/ng.3680. Epub 2016 Oct 10.

  PMID: 27723757 BACKGROUND

• Alikhan A, Felsten LM, Daly M, Petronic-Rosic V. Vitiligo: a comprehensive overview Part I. Introduction, epidemiology, quality of life, diagnosis, differential diagnosis, associations, histopathology, etiology, and work-up. J Am Acad Dermatol. 2011 Sep;65(3):473-491. doi: 10.1016/j.jaad.2010.11.061.

  PMID: 21839315 BACKGROUND

• Rashighi M, Harris JE. Vitiligo Pathogenesis and Emerging Treatments. Dermatol Clin. 2017 Apr;35(2):257-265. doi: 10.1016/j.det.2016.11.014.

  PMID: 28317534 BACKGROUND

• Whitton M, Pinart M, Batchelor JM, Leonardi-Bee J, Gonzalez U, Jiyad Z, Eleftheriadou V, Ezzedine K. Evidence-based management of vitiligo: summary of a Cochrane systematic review. Br J Dermatol. 2016 May;174(5):962-9. doi: 10.1111/bjd.14356. Epub 2016 Mar 25.

  PMID: 26686510 BACKGROUND

• Chen J, Wan Y, Lin Y, Jiang H. The application of platelet-rich plasma for skin graft enrichment: A meta-analysis. Int Wound J. 2020 Dec;17(6):1650-1658. doi: 10.1111/iwj.13445. Epub 2020 Jul 7.

  PMID: 32633467 BACKGROUND

• Lee WR, Shen SC, Al-Suwayeh SA, Li YC, Fang JY. Erbium:YAG laser resurfacing increases skin permeability and the risk of excessive absorption of antibiotics and sunscreens: the influence of skin recovery on drug absorption. Toxicol Lett. 2012 Jun 1;211(2):150-8. doi: 10.1016/j.toxlet.2012.03.797. Epub 2012 Mar 29.

  PMID: 22483991 BACKGROUND

• Zaleski-Larsen LA, Fabi SG. Laser-Assisted Drug Delivery. Dermatol Surg. 2016 Aug;42(8):919-31. doi: 10.1097/DSS.0000000000000556.

  PMID: 27191783 BACKGROUND

• Hou A, Cohen B, Haimovic A, Elbuluk N. Microneedling: A Comprehensive Review. Dermatol Surg. 2017 Mar;43(3):321-339. doi: 10.1097/DSS.0000000000000924.

  PMID: 27755171 BACKGROUND

• Vandervoort J, Ludwig A. Microneedles for transdermal drug delivery: a minireview. Front Biosci. 2008 Jan 1;13:1711-5. doi: 10.2741/2794.

  PMID: 17981662 BACKGROUND

• Wassef C, Lombardi A, Khokher S, Rao BK. Vitiligo surgical, laser, and alternative therapies: a review and case series. J Drugs Dermatol. 2013 Jun 1;12(6):685-91.

  PMID: 23839187 BACKGROUND

• Abdel-Hamid S, Ibrahim HM, Hameed AM, Hegazy EM. Effectiveness of fractional erbium-YAG laser, microneedling, platelet-rich plasma in localized stable vitiligo patients: randomized clinical trial. Arch Dermatol Res. 2024 Jun 15;316(7):399. doi: 10.1007/s00403-024-03035-8.

  PMID: 38878236 DERIVED

MeSH Terms

Interventions

Percutaneous Collagen Induction

Intervention Hierarchy (Ancestors)

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

Study Officials

• Hassan M Ibrahim, Ass. Prof

  southvalley university

  STUDY DIRECTOR

• Eisa M Hegazy, Ass. Prof

  southvalley university

  STUDY DIRECTOR

• Soheir ab Ali, Dr.

  southvalley university

  STUDY DIRECTOR

Central Study Contacts

aya ma hameed, resident

CONTACT

01091029334; ayamarouf956@gmail.com

Study Design

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

Model Details: (Group A): Subjected to fractional erbium: yttrium-aluminum-garnet (Er: YAG) laser (FotonaXs Dynamis, Slovenia) with the energy of 1400 mJ in short pulse mode (SP) with spot size of 7 mm diameter, frequency of 3 Hz, and pixel 1. PRP is applied over the treated areas. (Group B): Subjected to microneedling using electronic dermapen device (Dr Pen Derma Pen Ultima A6®) which has a disposable head that personalized for each patient . The derma pen will penetrate the skin with variable depths ranging from 0.25 to 0.5 mm (not more than the depth of the epidermis). It will pass vertically over the vitiligo area in a circular pattern from the perilesional areas toward the depigmented center until pinpoint bleeding appears then the PRP is applied over the treated areas. * This procedure will be repeated every two weeks for six months.

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 23, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 23, 2022

Record last verified: 2022-08