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

Not Applicable

• Conditions: Localized Vitiligo
• Interventions: Device: fractional Erbium-YAG laser; Device: microneedling

• Registration Number: NCT05511493
• Lead Sponsor: South Valley University

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.

Detailed Description

Vitiligo is a depigmentation disease characterised by epidermal melanocyte death and melanin loss. It affects less than 0.1% to greater than 8% of the world's population. It is caused by a dynamic interplay between genetic and environmental risks that initiates an autoimmune attack on melanocytes in the skin. There are some treatment modalities, such as topical steroids, topical calcineurin inhibitors, excimer laser, narrowband-ultraviolet B therapy (NB-UVB), vitamin D,and non-cultured epidermal cell suspension (NCES).

One of the representative autogenous regenerative biomaterials is platelet-rich plasma (PRP) which contains moderate to high concentrations of platelets together with multiple biomolecules and moderate concentrations of leucocytes. Activated platelets can release autogenous growth factors that may initiate a signalling cascades and lead to numerous intracellular changes, promoting the proliferation, migration, and differentiation of stem cells and regulating local inflammation and immune responses.

Laser- assisted drug delivery (LADD) functions by creating focused zones of selective epidermal damage thereby rendering the dermis more accessible to topical medication.

Multiple lasers have been applied for the purpose of LADD, including ablative fractional carbon dioxide (CO2) and erbium-doped yttrium-aluminum-garnet (Er: YAG) lasers.

Microneedling (Mn) is a minimally invasive process in which many tiny needles penetrate the skin. It augments transdermal drug delivery (TDD) through the creation of pores in the stratum corneum. This technique is also believed to induce pigmentation by physically moving melanocytes with the needles into the vitiligo areas from the pigmented areas, so that they may serve as reservoirs for melanogenesis, also it induces microinflammation which stimulates the migration of keratinocytes and melanocytes that induces the release of cytokines and growth factors stimulating melanocytes at the periphery of vitiligo patches and their migration from pigmented to unpigmented areas.

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-18
• Study First Submitted QC: 2022-08-20
• Last Update Submitted: 2022-08-20
• Study First Posted: 2022-08-23
• Last Update Posted: 2022-08-23
• Study Start: 2022-10-01
• Primary Completion: 2023-10-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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) .

2)Age between 10 - 60 years

Exclusion Criteria

• 1)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.

    4. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fractional(Er: YAG) laser with platelet-rich plasma	fractional Erbium-YAG laser	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
Microneedling with platelet-rich plasma	microneedling	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.

Primary Outcome Measures

Name	Time	Method
percentage of skin repigmentation of localized stable vitiligo	six month	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 .

Secondary Outcome Measures

Name	Time	Method
Response to treatment	six month	Response to treatment will be evaluated by photographing the patients and Physician's Global Assessment \[PGA\] at the baseline before the treatment and monthly after starting the treatment to detect the correlation between the degrees of repigmentation in both groups