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

Sponsor

South Valley University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05511493

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Localized Vitiligo	Device: fractional Erbium-YAG laser Device: microneedling	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

(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.(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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

aya marouf hameed aref, principal investigator, South Valley University

ClinicalTrials.gov Identifier:

NCT05511493

Other Study ID Numbers:

PRP in vitiligo

First Posted:

Aug 23, 2022

Last Update Posted:

Aug 23, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Vitiligo

Study Results

No Results Posted as of Aug 23, 2022