| CTRI Number |
CTRI/2024/03/063576 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
04/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To see the efficacy of oral minoxidil versus topical minoxidil in male pattern hair loss. |
|
Scientific Title of Study
|
Comparison Of efficacy Of oral minoxidil 1.25mg vs
topical minoxidil 5% in male androgenetic alopecia -a
randomised open label pilot study. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bikash Ranjan Kar |
| Designation |
HOD and Professor |
| Affiliation |
IMS and Sum hospital |
| Address |
Department of skin and venerology, ims and sum hospital,kalinganagar
Khordha
ORISSA
751003
India |
| Phone |
9937428181 |
| Fax |
|
| Email |
karbikash@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bikash Ranjan Kar |
| Designation |
HOD and Professor |
| Affiliation |
IMS and Sum hospital |
| Address |
Department of skin and venerology, ims and sum hospital,kalinganagar
Khordha
ORISSA
751003
India |
| Phone |
9937428181 |
| Fax |
|
| Email |
karbikash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bikash Ranjan Kar |
| Designation |
HOD and Professor |
| Affiliation |
IMS and Sum hospital |
| Address |
Department of skin and venerology, ims and sum hospital,kalinganagar
Khordha
ORISSA
751003
India |
| Phone |
9937428181 |
| Fax |
|
| Email |
karbikash@gmail.com |
|
|
Source of Monetary or Material Support
|
| IMS and SUM Hospital
Department of DVL
K 8, Kalinga Nagar
Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
not applicable |
| Address |
not applicable |
| Type of Sponsor |
Other [no] |
|
|
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 Bikash Ranjan |
institute of medical science and sum hospital |
Department of DVL
K 8, Kalinga Nagar
Bhubaneswar
Khordha
ORISSA |
9937428181
karbikash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ims and sum hospital |
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 |
oral minoxidil 1.25mg
|
tablet minoxidil 1.25mg once daily for 24 weeks
follow up every 4-weekly for 24weeks |
| Comparator Agent |
topical minoxidil 5% solution |
Topical minoxidil lotion 1ml once daily for 24 weeks
follow up 4-weekly for 24 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1.All males aged 18-45 yrs of age
2. Males with ( Hamilton Norwood Scale II-IV) |
|
| ExclusionCriteria |
| Details |
1.Severe hypertension, moderate hypertension on
antihypertensive therapy
2.Cardiovascular dysfunction
3.History of minoxidil hypersensitivity
4.On treatment with formulation of minoxidil, DHT-
blockers or other treatments for AGA in the past 3 months.
5.Psychiatric or scalp disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Clinical photographic assessment and quantitative
assessment using densitometer will be done.
2.Hair density calculation will be done in a square inch
area |
every monthly for 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The number of vellus hairs, terminal hairs determined by their thickness in the specific square inch area |
every monthly for 6 months |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
14/03/2024 |
| 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="0"
Months="6"
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
|
Low dose oral Minoxidil 0.25-5mg/day has been used off label to treat various forms of Alopecia.Oral Minoxidil has ; many patients find oral administration more convenient than topical application of a lotion or foam, topical application is operator dependent i.e some parts of the scalp may be missed in those with widespread alopecia, and low dose oral minoxidil circumvents the local side effects associated with topical minoxidil such as irritation and allergic contact dermatitis. One group shall be treated with oral minoxidil 1.25mg for 24 weeks 2. Second group shall be treated with topical minoxidil 5% for 24 weeks. Outcome- 1.Clinical photographic assessment and quantitative assessment using densitometer will be done. 2.Hair density calculation will be done in a square inch area from a point formed by intersection of lines joining glabella and occiput and joining the parietal prominences. 3.The number of vellus hairs, terminal hairs will be counted in the specific square inch area. |