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.: PACTR202006539654415 Date of Approval: 08/06/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluation of the safety and efficacy of platelet rich plasma in treatment of patients with chronic telogen effluvium
Official scientific title Evaluation of the safety and efficacy of platelet rich plasma in treatment of patients with chronic telogen effluvium: a randomized controlled, patient blind, evaluator blind, clinical trial.
Brief summary describing the background and objectives of the trial Chronic telogen effluvium (CTE) is characterized by diffuse hair loss of scalp persisting for more than six months. Treatment is primarily reassurance and counseling. One of the emerging lines of treatment is the use of platelet-rich plasma (PRP). However, no much published data exist in the literature in this regard. A randomized controlled study was conducted on CTE patients to evaluate the efficacy and safety of PRP. Also, to compare between the PRP preparation by ordinary laboratory tubes and special PRP kits tubes as regards the efficacy and safety.
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: Other
Anticipated trial start date 12/03/2018
Actual trial start date 12/03/2018
Anticipated date of last follow up 10/02/2020
Actual Last follow-up date 10/02/2020
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
307388 Medical ethics and scientific research Committee, Faculty of Medicine, Sohag University, Egypt
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Intradermal injection of scalp The participants received 4 sessions 4 months (session every month) Intra-dermal injection of the scalp with saline using 1 cm insulin syringe 10 Placebo
Experimental Group Intradermal injection of scalp using special platelet rich plasma tubes Group 1 The patients received 4 sessions The patients received 4 sessions (Monthly session) The patients were treated by platelet rich plasma (PRP) prepared by special PRP kits tubes (Zoom kits, Unex med company,made in Italy) that contain 1 cm sodium citrate 3.8% as anti-coagulant. 10 cm of blood was drown from the patients using 10 cm syringe and placed in the tubes. Then the tubes were shacked and placed in the centrifuge. The blood was centrifuged at 3500 rpm for 10 minutes. The centrifuge used was 80-1 Electronic Centrifuge, Made in China. 10
Experimental Group Intradermal injection of PRP using ordinary laboratory tubes. Group 2 The patients received 4 sessions 4 months (4 monthly sessions) The patients were treated with PRP prepared by ordinary laboratory tubes (sterile plastic conical 15 cm tubes, Made in Egypt). 1cm sodium citrate 3.8% (Bio-Tek Egypt Diagnostic company, Made in Egypt) was placed in the tube as anti-coagulant. 10 cm of blood was drown from the patients using 10 cm syringe and placed in the tubes. Then the tubes were shacked and placed in the centrifuge. The blood was centrifuged at 1000 rpm for 10 minutes. The same centrifuge was used as in group 1. 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
female patients chronic telogen effluvium patients (diffuse hair falling more than 6 months) aged between 18 and 55 years  Pregnant and lactating women.  Patients having any dermatological diseases affecting the scalp.  Thyroid dysfunction.  Chronic medical diseases.  Patients with anemia (hemoglobin level <10mg/dl), thrombocytopenia (platelet count < 100,000 /µL), coagulopathies or patients on anticoagulant therapy as aspirin and patients with iron deficiency.  Patients received topical or systemic treatment for hair loss in the last three months before the study. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 55 Year(s) Female
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 12/03/2018 Faculty of Medicine Sohag University
Ethics Committee Address
Street address City Postal code Country
Sohag University street Sohag 82524 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 15/05/2018 Faculty of Medicine Sohag University
Ethics Committee Address
Street address City Postal code Country
Sohag University street Sohag 82624 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Visual analogue scale (VAS) It helps to measure hair shedding which was scored on a scale of 1-6. Patients were asked to look at the scale and point to the photograph that best describes the amount of hair shed on an average day. Grades 1-3 were considered normal, Grade 4 was borderline, while Grades 5& 6 indicated excessive shedding Baseline, 1 month after end of treatment, 3 months after end of treatment
Primary Outcome Hair pull test (HPT): A bundle of hair was grasped between the thumb, index and middle finger from the base near the scalp, and firmly & slowly pulled. The extracted hairs were counted. Baseline, 1 month after end of treatment, 3 months after end of treatment
Primary Outcome Trichoscopy, The trichoscope used was (Micro-viewer 1.3 MP, Made in China), using lens (x200) magnification. 3 trichoscopic photos were taken from each of the frontal, temporal areas and vertex. It measured hair density (number of hairs/cm2), and hair thickness (mean/mm). Baseline, 1 month after end of treatment, 3 months after end of treatment
Primary Outcome Safety evaluation : safety was evaluated by monitoring any local side effects like (pain, itching, erythema, ecchymosis, headache and tightness ) or systemic side effects which were reported either by the patients and / or the physician. Baseline, 1 month after end of treatment, 3 months after end of treatment
Secondary Outcome Comparison of platelet concentration at the PRP, between the special PRP tubes and the ordinary laboratory tube At the last 4th session
Secondary Outcome Patient satisfaction, a 5-items questionnaire form was filled by patients to evaluate their satisfaction about the treatment Baseline, 1 month after end of treatment, 3 months after end of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Dermatology Faculty of Medicine Sohag University Sohag University street Sohag 82524 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Amr Abdelhamed Sohag University street Sohag 82524 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Sohag University Sohag University street Sohag 82524 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Reham ElDawla Sohag University Sohag 82524 Egypt
Marium Abdelhalem Sohag University Sohag 82524 Egypt
Amr Abdelhamed Sohag University Sohag 82524 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amr Abdelhamed dramr80@yahoo.com 00201005825574 Sohag University street
City Postal code Country Position/Affiliation
Sohag 82524 Egypt Lecturer Medical doctorate
Role Name Email Phone Street address
Scientific Enquiries Reham Eldawla walrehym@gmail.com 00201006809003 Sohag University street
City Postal code Country Position/Affiliation
Sohag 82524 Egypt Assistant professor Medical doctorate
Role Name Email Phone Street address
Public Enquiries Amr Abdelhamed dramr80@yahoo.com 00201005825574 Sohag University street
City Postal code Country Position/Affiliation
sohag 82524 Egypt Lecturer Medical doctorate
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD will include patients characteristics, laboratory investigations, hair evaluation including VAS, HPT and trichoscopy photos analysis. Also, the platelets concentration in the PRP. In addition, patient safety and treatment satisfaction questionnaire data Informed Consent Form,Statistical Analysis Plan,Study Protocol IPD/additional documents will be available after draft acceptance in Journal Access criteria will be controlled. The principle investigator will be responsible for reviewing requests for data 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