| CTRI Number |
CTRI/2024/08/071840 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing effectiveness of topical minoxidil versus topical minoxidil with dutasteride injections in male patients with male pattern hair loss |
|
Scientific Title of Study
|
Comparative study of topical minoxidil versus topical minoxidil with dutasteride mesotherapy in androgenetic alopecia A one year hospital based randomized control trial at tertiary care hospital |
| 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 Meenal Agrawal |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Nehru medical college,KLE university |
| Address |
Department of dermatology,venerology and leprosy, JNMC, KLE, belagavi,Karnataka
Belgaum KARNATAKA 590010 India |
| Phone |
8839619313 |
| Fax |
|
| Email |
Minalagrawal.sn@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shivakumar K Patil |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Nehru medical college,KLE university |
| Address |
Department of dermatology,venerology and leprosy, JNMC, KLE, belagavi,Karnataka
Belgaum KARNATAKA 590010 India |
| Phone |
9844512315 |
| Fax |
|
| Email |
shivakumarkpatil@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shivakumar K Patil |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Nehru medical college,KLE university |
| Address |
Department of dermatology,venerology and leprosy, JNMC, KLE, belagavi,Karnataka
Belgaum KARNATAKA 590010 India |
| Phone |
9844512315 |
| Fax |
|
| Email |
shivakumarkpatil@gmail.com |
|
|
Source of Monetary or Material Support
|
| 2nd floor, Skin OPD 23, Dr Prabhakar kore hospital,Jawaharlal Nehru medical college, Belgaum, Karnataka,590010 |
|
|
Primary Sponsor
|
| Name |
Dr. Meenal Agrawal |
| Address |
Department of dermatology,venerology and leprosy, JNMC, KLE, belagavi,Karnataka |
| Type of Sponsor |
Other [Self] |
|
|
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 Meenal Agrawal |
KLE,Dr Prabhakar kore hospital,Belgaum |
2nd floor, Skin OPD 23, Room number 2 Belgaum KARNATAKA |
8839619313
Minalagrawal.sn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC institutional ethics committee |
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 |
Dutasteride with topical minoxidil |
Mesotherapy with dutasteride will be done once monthly and topical minoxidil to be used 1ml twice daily |
| Comparator Agent |
Topical minoxidil |
This solution will be given to apply 1ml twice daily |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Male |
| Details |
Patient with Androgenetic Alopecia confirmed by clinical correlation and trichoscopy.
Male Patients belonging to age group of 18-55 years.
Patients of Norwood classification grading III,IV,V.
Patients with no known comorbidites |
|
| ExclusionCriteria |
| Details |
Norwood classification grading III, VI, VII.
Patients with other forms of alopecia
Patients with dermatological or systemic illness known to cause diffuse hair loss
Patients who received PRP or any hair growth promoters in the past six months
Patients who underwent surgical hair transplantation.
Patients on hormonal, androgenic or anti androgenic medications, cytotoxic, and inhibitors of
CYP3A4
Patients suffering from decreased libido, ejaculatory or erectile dysfunction
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increased hair density observed trichoscopically |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduced inter follicular distance observed trichoscopically |
4 months |
|
|
Target Sample Size
|
Total Sample Size="76" Sample Size from India="76"
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)
|
30/08/2024 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Although Androgenetic alopecia is often regarded as a rather minor dermatological condition, it affects one’s self-esteem and can be a major source of anxiety and depression for some men.Even while practicing dermatologists and hair specialists deal with it frequently, it might be one of the most difficult conditions to cure because choosing a course of therapy frequently requires careful evaluation of many different aspects as well as ethical decisionâ€making. The most crucial elements to take into account are treatment cost, practicality in terms of promoting compliance, side effect profiles, and effectiveness—especially in light of the chronic nature of the disease. While hair transplant surgery is an expensive alternative that may not always provide good results requiring numerous procedures to obtain the necessary hair density, medical treatment for AGA may not be suited for all people and may take a long time to show benefits. Therefore, if mesotherapy with dutasteride turns out to be as effective and safe as the current treatment, it might be a tempting substitute. |