Trial no.:	PACTR202108873035929	Date of Approval:	16/08/2021
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

Additive value of platelet rich plasma (PRP) in surgical treatment of stable vitiligo .A randomized double blind comparative study.

Official scientific title

The value of adding platelet rich plasma (PRP) to non cultured epidermal cell suspension (NCES) in surgical treatment of stable vitiligo .A randomized double blind comparative study.

Brief summary describing the background and objectives of the trial

Vitiligo is a quite distressing and challenging skin disorder. Vitiligo surgery; with non cultured epidermal cell suspension (NCES) being one of the most commonly used techniques, provides hope for otherwise resistant cases. However, in spite of improving the overall success rate of vitiligo treatment, it fails to achieve successful repigmentation in a good number of cases. Platelet rich plasma (PRP)has high growth promoting ,healing and regenerative capacity being rich in a multitude of growth factors like platelet derived growth factor (PDGF), transforming growth factor beta (TGF b), vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF) and insulin‐like growth factor (IGF). We assume that these growth factors, especially bFGF in PRP, would stimulate melanocyte migration along with the stimulation of keratinocytes and fibroblast proliferation. The addition of PRP to NCES thus should increase the rate and extent of repigmentation. Our objective is to assess the value of adding of PRP to the NCES via detecting percent reduction in the extent of vitiligo lesions treated by PRP suspended NCES compared to ones treated by saline suspended NCES through point counting technique as well as comparing improvement in pigmentation using VESTA Score (vitiligo extent score for a target area).

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Skin and Connective Tissue Diseases

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Treatment: Surgery

Anticipated trial start date

01/08/2021

Actual trial start date

Anticipated date of last follow up

30/11/2021

Actual Last follow-up date

Anticipated target sample size (number of participants)

30

Actual target sample size (number of participants)

Recruitment status

Completed

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Parallel: different groups receive different interventions at same time during study	Randomised	Simple randomization using by using procedures such as coin-tossing or dice-rolling	Sealed opaque envelopes	Masking/blinding used	Outcome Assessors

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	Non cultured epidermal suspension in platelet rich plasma	one time procedure	One day out patient procedure, consumes around 1.5 to 3 hours	Non cultured epidermal suspension(NCES) is one of the most commonly used surgical techniques in treatment of stable vitiligo. In this study, platelet rich plasma is added to the suspension in order to assess its additive value to the outcome of NCES.	15
Control Group	Non cultured epidermal suspension	One time procedure	One day procedure, takes around 1.5 to 3 hours	Non cultured epidermal suspension (NCES) is one of the most commonly used surgical techniques in treatment of stable vitiligo, where a thiersch graft is taken fro the buttocks and cells are trypsinized, washed and centrifuged and the resulting suspension is transplanted on a an abraded surface of stable vitiligo lesion.	15	Active-Treatment of Control Group

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
Patients with non-segmental stable vitiligo(NSV) with two comparable acral lesions, either symmetrical or in the same anatomical area. -patients with non acral vitiligo with lesions at elbows, knees or wrists. -Stability for ≥ 1 year -Age >12years - patients not on treatment for at least 1 month prior to surgery.	Non acral vitiligo in areas other than elbows , knees and wrists . -Segmental vitiligo. - Acral vitiligo responsive to conventional treatment modalities - Active vitiligo; new lesions, expansion of old lesions or koebnerization in < 1 year - Age < 12 years. -pregnant and lactating females.	Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s)	13 Year(s)	65 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

24/06/2021

research ethical committee faculty of medicine cairo university

Ethics Committee Address
Street address	City	Postal code	Country
El saray, El manial	cairo	11562	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	Assessing the additive value of PRP to NCES by comparing percent improvement in the lesion via point counting and Vitiligo Extent Score for target lesion VESTA Score .	3 months
Secondary Outcome	- Assessing the possible influence of disease duration , the age of the patient , the extent of lesional pigmentation prior to therapy (VESTA) and duration of stability on the outcome of the NCES compared to the PRP enriched NCES in patients with stable vitiligo	3 months

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Dermatology Department Kasr Alainy Hospital faculty of medicine cairo university	El Saray Street	cairo	11956	Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Dr. Dalia Abdel Halim	El Saray street El manial	cairo	11562	Egypt	Individual

COLLABORATORS
Name	Street address	City	Postal code	Country
Dr. Ahmed Fekry ... Dr. Rania Mogawer... Dr. Dalia Abdelhalim	El saray Street	Cairo	11562	Egypt

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Dalia Abdel Halim	daliaabdelhalim@hotmail.com	00201006059957	El Sarary street El manial
City	Postal code	Country	Position/Affiliation
cairo	11562	Egypt	Faculty of medicine Cairo university
Role	Name	Email	Phone	Street address
Public Enquiries	Ahmed Fekry	drmedical101@yahoo.com	00201113635646	El Saray Street, El manial
City	Postal code	Country	Position/Affiliation
Cairo	11562	Egypt	faculty of medicine cairo university
Role	Name	Email	Phone	Street address
Scientific Enquiries	Rania Mogawer	raniamogawer@kasralainy.edu.eg	00201068165330	El Saray Street El manial
City	Postal code	Country	Position/Affiliation
Cairo	11562	Egypt	faculty of medicine Cairo University

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)	Informed Consent Form,Statistical Analysis Plan,Study Protocol	Beginning 3 months and ending 12 months following article publication	Controlled access. Researchers who provide a methodologically sound proposal will be allowed to access data to achieve aims in the approved proposal. Proposal should be directed to daliaabdelhalim@hotmail.com to gain access
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information

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