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

August 20, 2022 updated by: aya marouf hameed aref, South Valley University

Efficacy of Platelet-rich Plasma With Fractional Erbium-YAG Laser Versus With Microneedling in Localized Stable Vitiligo

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: fractional(Er: YAG) laser with platelet-rich plasma

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
Platelet-rich plasma with fractional Erbium-YAG laser in localized stable vitiligo
Experimental: Microneedling with platelet-rich plasma

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
Platelet-rich plasma with microneedling in localized stable vitiligo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of skin repigmentation of localized stable vitiligo
Time Frame: 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 .
six month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response to treatment
Time Frame: 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
six month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Investigators

  • Study Director: Hassan M Ibrahim, Ass. Prof, southvalley university
  • Study Director: Eisa M Hegazy, Ass. Prof, southvalley university
  • Study Director: Soheir ab Ali, Dr., southvalley university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

August 18, 2022

First Submitted That Met QC Criteria

August 20, 2022

First Posted (Actual)

August 23, 2022

Study Record Updates

Last Update Posted (Actual)

August 23, 2022

Last Update Submitted That Met QC Criteria

August 20, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRP in vitiligo

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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