Evaluation of Human Melanocytes After the Use of PRP Versus Fractional CO2 Laser in Vitiligo (PRP)

March 23, 2020 updated by: Reham ElGibaly, Assiut University

Structural Evaluation of Human Melanocytes After the Use of Autologous Platelet-rich Plasma (PRP) Versus Fractional Carbon Dioxide Laser (Fr:CO2 Laser) in Treatment of Vitiligo: (A Histological, Immunohistochemical and Molecular Study )

Vitiligo is considered the most common chronic depigmentation disorder that affects around 0.5 -2% of the world population . In Africa , its prevelance is around 0.4% and 1.22 % in Assiut .

Treatment of vitiligo includes medical topical and systemic immune -suppressants ,phototherapy and surgical modalities .Despite the numerous treatment options , the treatment of choice is still controversial as the response is variable , unsatisfactory ,and requires a prolonged course. Therefore, new therapeutic approaches are required .

Platelet -rich plasma (PRP) is a treatment modality which has been used over the last several years in various medical and surgical fields . It is composed of high concentration of platelets , several growth factors and plasma proteins such as fibrin, fironectin ,vitronectin .This is hypothesized to stimulate keratinocytes and fibroblasts proliferation .

Another treatment modality is the fractional CO2 (Fr: CO2) laser .There are theories that fractional CO2 laser causes release of various types of cytokines and growth factors that can stimulate migration of melanocytes and act as mitogens for melanogenesis .

Melanogenesis is a complex process with involvement of multiple signaling pathways. Therefore, there have been extensive efforts to reveal the molecular mechanisms that control melanogenesis as the main step for treating hypopigmentary skin disorders .

There is yet very limited histopathological and molecular information about how the signaling networks are involved in the initiation , progression and also treatment of vitiligo disease.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Vitiligo is considered the most common chronic depigmentation disorder that affects around 0.5 -2% of the world population .In Africa , its prevelance is around 0.4% and 1.22 % in Assiut .

Vitiligo may appear at any age and affect both sexes. It is a cosmetically disfiguring disorder characterized by formation of depigmented patches of skin and /or mucosa.It has a psychological devastating effect which could lead to low self-steam and poor body image .

Vitiligo disease has three types according to the distribution of lesions ; segmental, non-segmental and mixed vitiligo .It could be classified as progressing or stable according to the activity of the disease .

Vitiligo pathogenesis includes many theories (the combination theory). The important theories include: autoimmune destruction of melanocytes, genetic predisposition , altered redox status and free radical mediated melanocyte damage , impaired melanocyte adhesion or melanocytorrhagy and heightened sympathetic response and catecholamines/ neurotransmitter mediated melanocyte damage .

The treatment of vitiligo depends upon the clinical diagnosis and usually includes two strategies.

The first strategy aims to provide stability by arresting the progression of the active disease and therefore limiting the depigmented areas. The second strategy is repigmentation of the depigmented areas Treatment of vitiligo includes medical topical and systemic immune -suppressants ,phototherapy and surgical modalities .

First line of treatment includes topical corticosteroids ,calcineurin inhibitors and phototherapy . While the second line of treatment includes systemic corticosteroids , topical calcipotriol and excimer laser .Surgical methods include skin /single-hair grafting , autologous cultured melanocyte or epidermal suspension transplantations and immunomodulators .

Despite the numerous treatment options , the treatment of choice is still controversial as the response is variable , unsatisfactory ,and requires a prolonged course . High proportion of vitiligo patients are resistant to the treatment. Therefore, new therapeutic approaches are required .

Platelet -rich plasma (PRP) is a treatment modality which has been used over the last several years in various medical and surgical fields .It is a simple and cheap new break thorough in soft tissue healing which has attracted the attention of dermatologists in the skin rejuvenation field .

PRP is composed of high concentration of platelets (seven times the normal blood level ), several growth factors and plasma proteins such as fibrin, fironectin ,vitronectin . Growth factors are known to regulate many processes such as cell migration , proliferation and differentiation .This is hypothesized to stimulate keratinocytes and fibroblasts proliferation .

Another treatment modality is the fractional CO2 (Fr: CO2) laser which represents a new modality for skin rejuvenation based on the theory of fractional photothermolysis . It has been used in treating facial photo-aging and scars . There are theories that fractional CO2 laser causes release of various types of cytokines and growth factors that can stimulate migration of melanocytes and act as mitogens for melanogenesis .

Melanogenesis is a complex process with involvement of multiple signaling pathways. Therefore, there have been extensive efforts to reveal the molecular mechanisms that control melanogenesis as the main step for treating hyperpigmentary skin disorders .

Molecular signaling pathways include p38 Mitogen-activated protein kinase (MAPK) , c-Jun N-terminal kinase /stress -activated protein kinase (JNK/SAPK) and extracellular signal-regulated kinase (ERK). These pathways are important in regulating cell proliferation ,differentiation and apoptosis of melanocytes .

Another important signaling pathway is protein kinase B ( Akt )which is involved in the differentiation of the keratinocytes. Activation of the Akt pathway triggers the differentiation process and is sustained until reaching the last stage of keratinocytes differentiation.

There is yet very limited histopathological and molecular information about how these signaling networks are involved in the initiation , progression and also treatment of vitiligo disease.

Study Type

Interventional

Enrollment (Anticipated)

30

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.

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

18 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age from 20-60 years old
  • Avoid using any other treatment modalities for vitiligo during the course of the study

Exclusion Criteria:

  • Pregnant and lactating women
  • local medications or laser therapy one month prior to the study
  • bleeding disorders
  • history of keloid formation
  • photosensitivity
  • seizure disorders

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Positive control group
Include the thirty patients before any treatment
Active Comparator: PRP group
Include fifteen patients that will recieve PRP sessions .Patients will receive six treatment sessions with one month interval for 6 months and will be followed up after 6 months.
Procedure: Platelet rich plasma

Eight milliliters of blood sample will be aspirated from the patient's peripheral vein, and the sample will be centrifuged at 1,500 rpm for 5 minutes.

A 30-G needle will be used for superficial intradermal (ID) microinjections (0.1 mL per injection and space about 1 cm apart)

Other Names:
  • PRP
Active Comparator: Fractional CO2 group
Include fifteen patients that will recieve FR: CO2 laser sessions.Patients will receive six treatment sessions with one month interval for 6 months and will be followed up after 6 months.
Procedure: Fractional CO2 laser

Fifteen lesions will be treated by Fr: CO2 laser (10,600 nm; KES Corporation, Beijing, China).

Scanner spot size will be adjusted based on the lesion size. Density selected will be 0.6 in the static mode.

Two passes with minimal overlap will be delivered. The laser will be applied to the vitiligo lesion and over a thin rim of healthy skin

Other Names:
  • Fr: CO2 laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
melanocyte cell quantification by light microscope
Time Frame: 1 year
Punch biopsy specimens will be stained by special immunohistochemical stain of Melan A antibody marker then counting melanocyte cells per field in five non overlapping fields using NIKON camera attached to a light microscope
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean improvement score by physician (MISP)
Time Frame: 1 year
MISP will be calculated by comparing the photographs. Physicians' clinical assessments will be done by two blinded dermatologists using a quartile grading scale (grade 1: <25%, no or minimal improvement; grade 2: 25%-49%, moderate; grade 3: 50%-74%, marked; grade 4: >75%-99%, excellent; and grade 5: 100%, complete)
1 year

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Amal T. ELghait, Professor, Assiut 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)

August 1, 2020

Primary Completion (Anticipated)

February 28, 2021

Study Completion (Anticipated)

October 24, 2022

Study Registration Dates

First Submitted

March 19, 2020

First Submitted That Met QC Criteria

March 23, 2020

First Posted (Actual)

March 24, 2020

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 70265

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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