| CTRI Number |
CTRI/2024/10/075292 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
09/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy and Safety of Oral Minoxidil in the treatment of Male Pattern Baldness |
|
Scientific Title of Study
|
Efficacy and Safety Of Oral Minoxidil in the Treatment of Male Androgenetic Alopecia in a Tertiary Care Center |
| 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 Farha P Nazeer |
| Designation |
DNB Post Diploma Trainee-Dermatology, Venereology and Leprosy |
| Affiliation |
Medical Trust Hospital |
| Address |
Department of Dermatology
MedTrust Aesthetics
Medical Trust Hospital
Mahatma Gandhi Rd
Pallimukku Kochi
Ernakulam
Kerala
Ernakulam
KERALA
682016
India |
| Phone |
9497278117 |
| Fax |
|
| Email |
farhapmnazeer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naveen Thomas |
| Designation |
Consultant Dermatologist |
| Affiliation |
Medical Trust Hospital |
| Address |
Department of Dermatology
MedTrust Aesthetics
Medical Trust Hospital
Mahatma Gandhi Rd
Pallimukku Kochi
Ernakulam
Kerala
Ernakulam
KERALA
682016
India |
| Phone |
9731222763 |
| Fax |
|
| Email |
naveenthomas04@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naveen Thomas |
| Designation |
Consultant Dermatologist |
| Affiliation |
Medical Trust Hospital |
| Address |
Department of Dermatology
MedTrust Aesthetics
Medical Trust Hospital
Mahatma Gandhi Rd
Pallimukku Kochi
Ernakulam
Kerala
Ernakulam
KERALA
682016
India |
| Phone |
9731222763 |
| Fax |
|
| Email |
naveenthomas04@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Farha P Nazeer |
| Address |
Medical Trust Hospital
Mahatma Gandhi Rd
Pallimukku
Kochi Ernakulam Kerala 682016 |
| 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 Farha P Nazeer |
Medical Trust Hospital |
MedTrust Aesthetics, Department of Dermatology
Medical Trust Hospital
Mahatma Gandhi Rd
Pallimukku Kochi
Ernakulam
Kerala
682016
Ernakulam
KERALA |
9497278117
farhapmnazeer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute 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 |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
Patients diagnosed with Male Androgenetic Alopecia with typical clinical presentation and trichoscopic finding.
Patients between the age of 18 - 50 years
|
|
| ExclusionCriteria |
| Details |
Those who are not willing for the study and who has been on treatment for hair loss for the past 3 months.
Patient with cardiac disease and hypotension
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in the parameters of the hair analysis namely the increase in the number of hairs per cm2 and increase in the hair diameter measured by Foto finder and an improvement in photographic assessment done by two independent observers
|
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the patient satisfaction score analyzed by the questionnaire |
4 months
|
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/10/2024 |
| 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
|
Androgenetic Alopecia is the most common type of non-scarring alopecia in male. The aim of the study is to evaluate the efficacy and safety profile of low dose oral minoxidil (2.5mg) in male suffering from androgenetic alopecia. The study is planned for 12 months. The subjects will be selected and observed from among the patients who come for the treatment of MAGA, who are not on any treatment for the past 3 months, has undergone trichoscan examination and has been started on 2.5 mg of oral minoxidil for the treatment of the same. Socio-demographic data, global photographic assessment and trichoscan findings will be collected using a proforma after obtaining consent. |