| CTRI Number |
CTRI/2024/08/072896 [Registered on: 22/08/2024] Trial Registered Prospectively |
| Last Modified On: |
13/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The Efficacy of Low dose oral minoxidil tablets in treatment of Androgenetic Alopecia |
|
Scientific Title of Study
|
Prospective Single Arm Open Label case study to evaluate the Efficacy of Low dose oral minoxidil tablets in treatment of 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 P S Mohanasundari |
| Designation |
Assistant professor |
| Affiliation |
Government Stanley Medical College and Hospital |
| Address |
1,Government Stanley Medical College,SSB First floor, Department of DVL, old jail road, George town,Chennai
Chennai
TAMIL NADU
600001
India |
| Phone |
9444038838 |
| Fax |
|
| Email |
psm.sundari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Anandan |
| Designation |
Assistant professor |
| Affiliation |
Government Stanley Medical College and Hospital |
| Address |
1,Government Stanley Medical College,SSB First floor, Department of DVL, old jail road, George town,Chennai
Chennai
TAMIL NADU
600001
India |
| Phone |
9841043213 |
| Fax |
|
| Email |
dermanandan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrPSMohanasundari |
| Designation |
Assistant professor |
| Affiliation |
Government Stanley Medical College and Hospital |
| Address |
1,Government Stanley Medical College,SSB First floor, Department of DVL, old jail road, George town,Chennai
Chennai
TAMIL NADU
600001
India |
| Phone |
9444038838 |
| Fax |
|
| Email |
psm.sundari@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrPSMohanasundari |
| Address |
1,Government Stanley Medical College,SSB First floor, Department of DVL, old jail road, George town,Chennai |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DrSoundharya |
1,Old jail road, George town, Chennai 600001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrPSMohanasundari |
Government Stanley Medical College |
1,Government Stanley Medical College,SSB First floor, Department of DVL, old jail road, George town,Chennai
Chennai
TAMIL NADU |
9444038838
psm.sundari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Stanley Medical College and Hospital, Chennai -01, 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 |
Not applicable |
Not applicable |
| Intervention |
Oral minoxidil |
Low dose oral minoxidil 2.5mg OD and 1.25mg OD in treatment of male and female patterend hair loss respectively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patient who give consent to the study and followup
Patient with age group more than 18 years of both sex
Patient diagnosed with Androgenetic alopecia male or female patterned hair loss (having grade I to V Norwood Hamilton scale , I to III Ludwigs scale )
Patient who allows to take photographs. |
|
| ExclusionCriteria |
| Details |
Patient age less than 18 years of age.
Patients not willing to participate in this study.
Patient with comorbities such as hypertension , Cardiovascular disorder , renal disease , liver disease, thyroid disorder, hyperandrogenism (PCOS )or another significant Medical condition that may contraindicate the use of minoxidil.
Patient with diagnosis other than male and female patterend hair loss Androgenetic alopecia.
Patient on treatment with topical minoxidil or any other treament for hairloss.
Patient with known hypersensitivity or allergy to Minoxidil .
Patient taking medication that interfere with minoxidil such as beta blockers , vasodilators .
Patient who have participated in another clinical study involving hair growth treatments within past three months.
Pregnancy and lactating mother.
Patient with unrealistic expectation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assess the hair regrowth by measuring hair desnsity and hair count by dermoscopy/phototrichogram. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compare the effects of low dose oral minoxidil in male and female pattern hairloss. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Post Marketing Surveillance |
|
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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 22-07-2024 and end date provided 22-01-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Patients satisfying the criteria were included in the study and demographic details will be recorded. A detailed clinical history , a complete general examination, systemic examination and dermatological examination will be made. Assessing the severity of hairloss in the patient by standardized hairloss assessment scales like Norwood Hamilton scale for males and Ludwig scale for females. Digital photographs will be taken. Appropriate blood test complete blood count, liver function test, renal function test Thyroid function test,,ECG will be taken. Male patient with patterned hair loss will be given oral minoxidil 2.5mg OD and female patient with patterend hairloss will be given oral minoxidil 1.25mg OD for a period of 24 weeks , follow up of the patient by every 4weeks once . |