| CTRI Number |
CTRI/2024/07/070098 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
05/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to compare minoxidil lotion and minoxidil plus platelet rich plasma therapy in male pattern hairloss |
|
Scientific Title of Study
|
Trichoscopic comparison of 5% minoxidil lotion monotherapy versus its combination with autologous platelet rich plasma therapy in androgenetic alopecia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR GOPAL PRASAD PODDAR |
| Designation |
Junior Resident |
| Affiliation |
Era’s Lucknow Medical College and Hospital |
| Address |
Department of dermatology
Era’s Lucknow Medical College and Hospital
Sarfarazganj
Lucknow, Uttar pradesh
Lucknow UTTAR PRADESH 226003 India |
| Phone |
09634063680 |
| Fax |
|
| Email |
poddargopal19@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR KSHITIJ SAXENA |
| Designation |
Professor |
| Affiliation |
Era’s Lucknow Medical College and Hospital |
| Address |
Department of Dermatology
Era ‘s Lucknow Medical College and Hospital
Sarfarazganj
Lucknow, Uttar pradesh
Lucknow UTTAR PRADESH 226003 India |
| Phone |
9208015391 |
| Fax |
|
| Email |
drkshitijsaxena@live.com |
|
Details of Contact Person Public Query
|
| Name |
DR GOPAL PRASAD PODDAR |
| Designation |
Junior Resident |
| Affiliation |
Era’s Lucknow Medical College and Hospital |
| Address |
Department of dermatology
Era’s Lucknow Medical College and Hospital
Sarfarazganj
Lucknow, Uttar pradesh
Lucknow UTTAR PRADESH 226003 India |
| Phone |
09634063680 |
| Fax |
|
| Email |
poddargopal19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Era s lucknow medical college and hospital
Sarfarazganj
Lucknow, Uttar Pradesh
226003
India
|
|
|
Primary Sponsor
|
| Name |
ERA S LUCKNOW MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of dermatology
Era s lucknow medical college and hospital
Sarfarazganj
Lucknow, Uttar pradesh, 226003
|
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR GOPAL PRASAD PODDAR |
Era s lucknow medical college and hospital |
Department of dermatology
Room No.2
Era s lucknow medical college and hospital
Sarfarazganj
Lucknow, Uttar Pradesh
226003 Lucknow UTTAR PRADESH |
9634063680
poddargopal19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Eras Lucknow Medical College and Hospital, Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L649||Androgenic alopecia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
5% MINOXIDIL |
Minoxidil Dose-5%
Frequency-Twice Daily
Route- Topical application over the scalp
Follow up- 3weeks, 6weeks,9weeks, 12weeks
Duration of study- 12 weeks after completion of trial period, treatment of patient with the drug shall continue if necessary. |
| Comparator Agent |
5% MINOXIDIL AND PLATELET RICH PLASMA THERAPY |
Minoxidil 5% +
Platelet rich plasma therapy
Dose(Minoxidil)- 5%
Frequency(Minoxidil 5%)-Twice Daily
Frequency(Platelet rich plasma therapy)-Thrice weekly
Route (Minoxidil 5%)- Topical application over the scalp
Route(Platelet rich plasma therapy)- intradermal
Follow up- 3weeks, 6weeks,9weeks, 12weeks
Duration of study- 12 weeks after completion of trial period, treatment of patient with the drug shall continue if necessary. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
All consenting male patients in the age group of 20–50 years with AGA stage II–VI Norwood-Hamilton classification visiting in dermatology OPD. |
|
| ExclusionCriteria |
| Details |
1.Patients who have taken any form of treatment in past three months.
2.Patient with a history of hypersensitivity to minoxidil.
3.Patient with a history of bleeding disorders, on anticoagulants medications (aspirin, warfarin, heparin) and and with positive viral markers.
4.Patients with active infection at local site, nonpatterned alopecia, keloidal tendency, history of psoriasis, lichen planus and vitiligo.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •To trichoscopically assess and compare the effectiveness of 5% minoxidil alone and its combination with platelet rich plasma therapy. |
Baseline,3 Weeks,6 Weeks,9 Weeks,12 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•To trichoscopically evaluate the response in patient with 5% minoxidil monotherapy in individuals with AGA.
•To trichoscopically evaluate the synergistic effects of the combined therapy of 5% minoxidil & PRP in individuals with AGA.
•To analyze potential side effects during the course of treatment.
|
Baseline,3 Weeks,6 Weeks,9 Weeks,12 weeks |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
16/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A total of 60 patients of androgenetic alopecia visiting dermatology OPD of Era’s Lucknow Medical College and Hospital fulfilling inclusion criteria will be enrolled in our study. Written and informed consent from patients will be taken prior to participation in study. Patients will be randomly divided into two groups A and B each containing 30 individuals each. History, clinical examination with trichoscopic evaluation and photographic documentation will be done before the start of the treatment and then at each visit (baseline,3weeks,6weeks,9 weeks and 12 weeks) and results will be tabulated in respective tables. In group A- each patient will be advised minoxidil (5%) twice daily application over scalp for 3weeks with follow up at every 3 week. In group B- each patient will be advised minoxidil (5%) twice daily application over scalp for 3 weeks with platelet rich plasma therapy sessions over scalp at every 3 weeks with follow up at every 3week. Under aseptic precautions, around 16ml of peripheral blood will be collected from the median cubital vein and transferred into a sodium citrate vacutainer. The tubes will be rotated in a centrifuge machine (REMI) at 2,000 revolutions per minute for 6 minutes and the Buffy coat along with the plasma will be collected with the help of a pipette in another test tube. This tube will again be subjected to asecond centrifugation at 4000 revolutions per minute for 10 minutes. The upper layer containing platelet poor plasma will be discarded, and the lower layer of the PRP will be collected in another clean tube. Multiple PRP injections of 0.1 ml will be given at each site in a linear pattern 1 cm apart using the nappage technique. |