| CTRI Number |
CTRI/2024/03/063787 [Registered on: 07/03/2024] Trial Registered Prospectively |
| Last Modified On: |
08/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of the low dose oral minoxidil in the post hair transplant treatment |
|
Scientific Title of Study
|
Evaluating the efficacy of low dose oral minoxidil Post Hair Transplant, in patterned hair loss: A Prospective Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CACS (23-24)-011, Version:1 dated:16 Nov 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Megha C |
| Designation |
Consultant Dermatologist and HOD.of Trichologist |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
Department of Trichology
Room No 19
5/1,4th Main MRCR Layout Vijayanagar 5/1,4th Main MRCR Layout Vijayanagar Bangalore KARNATAKA 560040 India |
| Phone |
8095196167 |
| Fax |
|
| Email |
drmeghacs@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Megha C |
| Designation |
Consultant Dermatologist and HOD.of Trichologist |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
Department of Trichology
Room No 19
5/1,4th Main MRCR Layout Vijayanagar 5/1,4th Main MRCR Layout Vijayanagar Bangalore KARNATAKA 560040 India |
| Phone |
8095196167 |
| Fax |
|
| Email |
drmeghacs@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Megha C |
| Designation |
Consultant Dermatologist and HOD.of Trichologist |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
Department of Trichology
Room No 19
5/1,4th Main MRCR Layout Vijayanagar 5/1,4th Main MRCR Layout Vijayanagar Bangalore KARNATAKA 560040 India |
| Phone |
8095196167 |
| Fax |
|
| Email |
drmeghacs@gmail.com |
|
|
Source of Monetary or Material Support
|
| CUTIS Academy of Cutaneous Sciences
5/1,4th Main MRCR Layout Vijayanagar Bangalore 560040 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NIL |
| Type of Sponsor |
Other [NA] |
|
|
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 Megha C |
CUTIS Academy of Cutaneous Sciences |
Department of Trichology Room No 19
5/1,4th Main MRCR Layout Vijayanagar
5/1,4th Main MRCR Layout Vijayanagar Bangalore KARNATAKA |
8095196167
drmeghacs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CUTIS 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 |
| Comparator Agent |
NA |
NA |
| Intervention |
Oral Minoxidil: 0.25mg followed by 0.5mg tab |
First week 0.25-tab followed by 0.5 tab for a week followed by 1 tab for a week and continue to 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All male patients who undergo hair transplantation following no response to conventional therapies
Patient consenting for study |
|
| ExclusionCriteria |
| Details |
Patient with history of cardio vascular diseases
Patients with chronic renal diseases
Patient with history of hypotension
Patient taking medications like aspirin, blood thinners and guanethidine |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of oral minoxidil in post hair transplantation patients.
To assess the safety and adverse effects associated low dose oral minoxidil.
To evaluate patient satisfaction and subjective perceptions of treatment outcome. |
After 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy will be evaluated by hair counts, hair diameter measurements, anagen telogen ratio photographic assessment by trichoscan |
After 6 months |
|
|
Target Sample Size
|
Total Sample Size="10" Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
Phase of Trial
Modification(s)
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/03/2024 |
| Date of Study Completion (India) |
08/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Androgenetic alopecia (AGA), colloquially known as male or
female pattern baldness, is a hereditary condition characterized by progressive
hair thinning and loss. It is the most common cause of hair loss, affecting
both men and women. AGA results from a complex interplay of genetic and
hormonal factors, particularly the influence of androgens like
dihydrotestosterone (DHT) on susceptible hair follicles. The psychological impact of AGA can
be profound, affecting self-esteem and quality of life. While not curable,
various treatments, including topical minoxidil, oral finasteride, and hair
transplantation, aim to slow progression or restore hair density (1)
Hair transplantation (HT) is a method
of transferring hair follicles from a donor area to a recipient/bald area. The
most commonly chosen donor site is the occipital region as the hair in this
region is unaffected by AGA. When the hair in the occipital region is scanty or
insufficient, facial hair and body hair may be used. The rationale for hair
transplantation in AGA is donor dominance, i.e., the transplanted hair
continues to be unaffected by the balding process even after relocation to the
new site (2). Hair transplantation is a widely adopted solution for
androgenetic alopecia, yet postoperative challenges persist, such as delayed
growth and donor site scarring.
This research investigates the potential of oral minoxidil in
enhancing post-transplantation outcomes. Recognizing the need for adjunctive
therapies, we explore the rationale behind incorporating oral minoxidil,
initially a vasodilator, and its impact on graft survival, growth acceleration,
and overall patient satisfaction.
Minoxidil is the only other drug that is
approved by the USFDA for the treatment of AGA. After conversion to its active
form, i.e., minoxidil sulphate, it acts on the receptors on arterial smooth
muscle cells to cause vasodilatation. This leads to a prolonged anagen of the
miniaturized hair follicle and reduced shedding |