Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
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