| CTRI Number |
CTRI/2024/07/070098 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/08/2026 |
| 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)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
16/07/2024 |
| Date of Study Completion (India) |
27/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Background: Minoxidil is the standard treatment for Androgenetic Alopecia (AGA), platelet rich plasma (PRP) therapy is emerging as an adjuvant therapy to augment the outcomes. Objective: To compare the response of 5% minoxidil alone and its combination with PRP in males with androgenetic alopecia (AGA) using trichoscopy. Methods: A total of 60 AGA patients fulfilling the eligibility criteria (age range 19-41 years; mean age 26.35±4.97 Years) were enrolled and were randomized equally into two groups, Group A(Monotherapy) receive application of Minoxidil (5%) over scalp twice daily for 3 weeks and Group B (Combination) application of Minoxidil (5%) over scalp twice daily for 3 weeks with PRP therapy at every three weeksrespectively. Trichoscopy was performed at enrolementand at every 3 weekly interval till 12 weeks follow up. Change in grade and Trichoscopic findings was done at every follow-up. Adverse drug reactions were noted. Subjective improvement was also noted. Results: Both the groups had a comparable demographic and clinical profile. After 12 weeks, as compared to Combination group, Monotherapy group had higher proportion of cases for trichoscopic outcomes like hair shaft thickness heterogeneity (50% vs 23.3%; p<0.001), however for other trichoscopy outcomes there was no significant difference between two groups. Marked to complete improvement was higher in Combination group (80%) as compared to that in Monotherapy group but this difference was not significant statistically (80% vs 46.7%; p=0.060). Adverse effects were higher in Combination than in Monotherapy group. Conclusion: Minoxidil in combination with PRP provided better outcome than Minoxidil alone on trichoscopic examination. |