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.: PACTR202301820107782 Date of Approval: 13/01/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of autologous platelet rich plasma on morphea: A comparative clinical and ultrasonographic follow up study
Official scientific title Efficacy of autologous platelet rich plasma on morphea: A comparative clinical and ultrasonographic follow up study
Brief summary describing the background and objectives of the trial Platelet-rich-plasma (PRP) is an effective treatment for skin atrophy with limited side effects. In this study we aimed to evaluate the efficacy and safety of PRP to restore skin changes in morphea such as ( skin atrophy, dyspigmentation and adnexal destruction) by ultrasound and Localized Scleroderma Cutaneous Assessment Tool (LoSCAT).
Type of trial CCT
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: Other
Anticipated trial start date 01/06/2021
Actual trial start date 17/07/2021
Anticipated date of last follow up 30/09/2022
Actual Last follow-up date 30/09/2021
Anticipated target sample size (number of participants) 12
Actual target sample size (number of participants) 9
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Platelet rich plasma one ml. PRP for each one cm. of the skin every week for twelve sessions three months Venous blood sample was obtained in special sterile tubes containing an anticoagulant Na citrate 3.8%. Then at room temperature, each test tube underwent an 8-minute, 800 rpm centrifugation. PRP was carefully aspirated from the test tube into a syringe, transferred to another tube, and then centrifuged once more at 1200 rpm for 12 minutes to separate it into two parts: platelet-poor plasma in the upper part and PRP in the lower part. To prevent it from mixing with the PRP, the platelet-poor plasma was first gently extracted. The remaining PRP was then aspirated for injection. The PRP solution was injected intradermally using a "serial puncture," the entire needle was inserted with a 1 cm gap between each point once weekly for 12 sessions. 9
Control Group ultrasound assessment of contralateral healthy area at base line three months All cases were studied with ultrasound device (8-14 MHz) with high-frequency linear probe (Toshipa, xario 200, Japan). All the clinically affected (exprimental group) areas were examined and were compared to the corresponding anatomical side as a healthy control. 9 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with acute or chronic morphea 1- Patients using anti-coagulation therapy, non-steroidal anti-inflammatory drugs, 2- patients having other connective tissue autoimmune diseases, chronic liver disease, blood diseases, critical thrombocytopenia or HIV and uncontrolled diabetes. 3- Patients who received topical or systemic treatment for morphea in the last month. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 13 Year(s) 46 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 03/12/2022 Faculty of Medicine ethics committee
Ethics Committee Address
Street address City Postal code Country
1 Al-Azhar University Square, Faculty of Medicine Assiut 71524 Egypt
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 03/12/2020 Quality control unit
Ethics Committee Address
Street address City Postal code Country
King Faisal st. Assiut 71524 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome clinical cosmetic improvement using the Localized Scleroderma Assessment Tool (LoSCAT). at base line, three months and after six months follow up
Secondary Outcome Ultrasonographic improvement using high frequency linear transducer machine At base line, three months and six months follow up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dermatology department Al-Azhar University hospital, King Fiasal st. Assiut 71524 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Esraa Elnaquib 1 Al-Azhar University square Assiut 71524 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dermatology department King Faisal, Al-Azhar University hospital Assiut 71524 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Musculoskeletal Ultrasound unit Rheumatology department King Faisal st. Al-Azhar University hospital Assiut 71524 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Esraa Elnaquip saraelnakib54@gmail.com 00201122876019 Ras Eltin General Hospital st
City Postal code Country Position/Affiliation
Alexandria Egypt Resident physician dermatology department
Role Name Email Phone Street address
Public Enquiries Mahmoud Makky makkiderma@yahoo.com 00201068753876 King Faisal, Al-Azhar University hospital, dermatology department
City Postal code Country Position/Affiliation
Assiut Egypt Assistant professor dermatology department
Role Name Email Phone Street address
Scientific Enquiries Abdelhfeez Moshrif dr.moshrif@live.com 00201062930120 King Faisal Al-Azhar University hospital Rheumatology department
City Postal code Country Position/Affiliation
Assiut Egypt Assistant professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data will be shared with the Sponsor. For the medical community, summary-level statistical analyses will be shared. Information collected or generated during this study may be anonymised for use to support new research on dermatological use of platelet rich plasma. Statistical Analysis Plan,Study Protocol one year after the completion of data collection On completion of the trial and submission of the manuscript. De-identified trial data that underlies the results reported in the publication will be available upon a justified request to the main investigator.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 09/12/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 09/12/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information