| CTRI Number |
CTRI/2018/05/014113 [Registered on: 25/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
09/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [Subcutaneous Injection of platelet rich plasma in scalp] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Platelet rich plasma (PRP) role in the treatment of baldness |
|
Scientific Title of Study
|
Role of platelet rich plasma (PRP) in the treatment of male type baldness |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijay Kumar |
| Designation |
Junior resident |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of Dermatology and Venereology
Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7084746942 |
| Fax |
|
| Email |
drvijaykumarbhu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyendra Kumar singh |
| Designation |
Professor and Head |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of Dermatology and Venereology
Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9198120582 |
| Fax |
|
| Email |
drsatyendraderma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Kumar |
| Designation |
Junior resident |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of Dermatology and Venereology
Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7084746942 |
| Fax |
|
| Email |
drvijaykumarbhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dermatology and venereology
Institute of medical Sciences
Banaras Hindu University |
|
|
Primary Sponsor
|
| Name |
Institute of Medical sciences Banaras Hindu University |
| Address |
Institute of Medical sciences, Banaras Hindu University,
Varanasi 221005 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Tulika Rai |
Assistent Professor
Department of Dermatology and Venereology
Institute of Medical Sciences
Banaras Hindu University
varanasi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vijay Kumar |
Sir Sunder Lal Hospital |
Room No 207 Skin OPD Department of dermatology and venereology Sir sunder Lal Hospital
Banaras Hindu University
Varanasi
UTTAR PRADESH |
7084746942
drvijaykumarbhu@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Male type baldness, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Minoxidil 5% |
minoxidil 5% solution topical application 1 ml twice daily over whole scalp for 5 months |
| Comparator Agent |
Normal saline |
Subcutaneous injection of normal saline three sittings over whole scalp followed by 3 month follow up. |
| Intervention |
Platelet Rich Plasma |
subcutaneous injection of platelet rich plasma monthly for three sitting over whole scalp followed by 3 month follow up
platelet rich plasma prepared from patient own blood after centrifuge. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1. All the patients not using topical minoxidil and finasteride for at least 6 months will be considered for PRP therapy.
2. Age group 20 – 60 years
3. Sex- Male
4. Mild to moderate AGA (Hamilton-Norwood score II-V) .
5. Patients willing to come for follow up every month for 5 months.
|
|
| ExclusionCriteria |
| Details |
1. Patients not giving informed written consent, unable to understand the protocol and uncooperative patients.
2. Any inflammation, erythema or scarring over scalp except mild seborrheic dermatitis.
3. Patients who have history of malignancies, platelets disorders or bleeding disorders, anemia ( haemoglobulin of less than 10 gm/dl), bone marrow aplasia, diabetes, sepsis, and cancer.
4. Patients taking theses any of these medications-
i. Anti-coagulants – heparin, warfarin
ii. Anti-hypertensives – beta-blockers, ACE inhibitors hormones
iii. Anticonvulsants – valproic acid, carbamazepine, phenytoin, mood stabilizers Antidepressants, lithium
iv. Aspirin or any non-steroidal anti-inflammatory drugs two week prior to procedure.
v. Other medications cimetidine, retinoids (acitretin > isotretinoin), antithyroid drugs, cholesterol lowering drugs, interferons, amphetamines, bromocriptine, levodopa, some antipsychotic and anti-anxiety drugs, rarely tricyclic antidepressants such as amitriptyline
5. Patients who are known to be HIV, hepatitis B or C positive or otherwise immunocompromised.
6. Patients with a propensity for keloids
7. Patients on antiplatelet drugs like aspirin or non-steroidal anti-inflammatory drugs.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Hair density
Hamilton Norwood grading
Patient self assessment |
every month for 5 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Age
sex
occupation
Education status
Family History
History of previous treatment for male type baldness
Effect on personality
|
Every month for 5 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
08/02/2017 |
| Date of Study Completion (India) |
24/02/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Total 36 research was done.
Few of them mentioned below
Singh SK, Kumar A, Nath G, Singh TB, Mishra MN. Resistance to anti leprosy drugs in multi-bacillary leprosy: A cross sectional study from a tertiary care centre in eastern Uttar Pradesh, India. Indian Journal of Dermatology, Venereology, and Leprology. 2018 May 1;84(3):275.
Singh SK, Nasir F. The reservoir effect of topical steroids in vitiliginous skin: A cross-sectional study. Indian Journal of Dermatology, Venereology, and Leprology. 2015 Jul 1;81(4):370. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Androgenetic alopecia (AGA) is a common chronic hair loss disorder. It is characterized by progressive hair loss, affecting both sexes. AGA is considered to be the most common type of baldness characterized by progressive hair loss. PRP has also attracted attention in plastic surgery and dermatology because of its potential use during facial plastic surgery and aesthetic, skin-rejuvenating effects and in hair loss. PRP is a new method as seen in previous studies PRP seems to be a promising new technique may improve hair regrowth, thereby making the PRP procedure an alternative to finasteride or minoxidil. Study design: a randomized, double-blind controlled trial, four groups study. Four different groups are: 1. Patient was given minoxidil solution 5% topically 1ml over whole scalp two times a day throughout the study period with intralesional(placebo) injection of Normal saline 0.9% monthly for 3 months. 2. Patients was given minoxidil solution 5% topically 1ml over whole scalp two times a day throughout the study period with intralesional injection of PRP monthly for 3 months. 3. Patient was given topical placebo containing (58ml of Normal saline 0.9% and 2 ml spirit) topically 1ml over whole scalp two times a day throughout the study period with intralesional(placebo) injection of Normal saline 0.9% monthly for 3 months Patient was given topical placebo containing (58ml of Normal saline 0.9% and 2 ml spirit) topically 1ml over whole scalp two times a day throughout the study period with intralesional injection of PRP monthly for 3 months. Patient randomization was done using website www.radomizer.org. All four groups will be compare for efficacy, adverse effect monthly for 5 months. |