| CTRI Number |
CTRI/2024/08/072403 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
10/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of using enzyme which boost the activity of minoxidil in the treatment of Male baldness |
|
Scientific Title of Study
|
Comparing the efficacy of topical application of 5 percent MINOXIDIL ALONE vs topical SULFOTRANSFERASE (SULT1A1) enzyme booster followed by 5 percent MINOXIDIL in the treatment of androgenetic alopecia- A non blinded randomized control study among patients attending dermatology and cosmetology opd |
| 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 Ranjith kumar U |
| Designation |
Post graduate |
| Affiliation |
The Tamilnadu Dr. M.G.R. medical university, chennai |
| Address |
Dept of DVL
Stanley medical college and hospital
no. 1, old jail road, george town, chennai
chennai
Chennai
TAMIL NADU
600001
India |
| Phone |
9787208384 |
| Fax |
|
| Email |
ranjithu96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saravanan N |
| Designation |
Professor |
| Affiliation |
The Tamilnadu Dr. M.G.R. medical university, chennai |
| Address |
Dept of DVL
Stanley medical college and hospital
no. 1, old jail road, george town, chennai
chennai
Chennai
TAMIL NADU
600001
India |
| Phone |
9444500333 |
| Fax |
|
| Email |
saransudar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saravanan N |
| Designation |
Professor |
| Affiliation |
The Tamilnadu Dr. M.G.R. medical university, chennai |
| Address |
Dept of DVL
Stanley medical college and hospital
no. 1, old jail road, george town, chennai
chennai
Chennai
TAMIL NADU
600001
India |
| Phone |
9444500333 |
| Fax |
|
| Email |
saransudar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt. stanley medical college and hospital,
No.1, old jail road, George Town, chennai- 600001,
Tamilnadu, India |
|
|
Primary Sponsor
|
| Name |
Dr. Ranjith kumar |
| Address |
Dept of DVL
Stanley medical college
chennai- 600001 |
| 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 Ranjith kumar U |
Govt stanley medical college and hospital |
Department of DVL,
Room no.81, 1st floor superspeciality block
Chennai
TAMIL NADU |
9787208384
ranjithu96@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 |
Topical 5% minoxidil alone |
Male patients with androgenetic alopecia are advised to apply 1 ml of topical 5% minoxidil alone two times a day for 6 months |
| Intervention |
Topical sulfotransferase(SULT1A1) enzyme booster followed by topical 5% minoxidil |
Male patients with androgenetic alopecia are advised to apply 1 ml of topical sulfotransferase(SULT1A1) enzyme booster 15-20 minutes before applying 1 ml of topical 5% minoxidil two times a day for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Male patients having Androgenetic alopecia grade 2 to 5(Norwood Hamilton scale)
Age between 18 years and 45 years
Patients willing for the study, consent and follow up
Patients not on any other treatment for androgenetic alopecia for past 6 months |
|
| ExclusionCriteria |
| Details |
Patients below 18 years and above 45 years.
Female patients having androgenetic alopecia.
Concomitant dermatological disorders on the scalp other than androgenetic alopecia, serious cardiovascular disease, hepatic diseases, renal diseases.
History of treatment with systemic or locally acting medication which may interfere with the study objectives, such as minoxidil, finasteride treatment in the past 6 months or treatment with other hair growth products in the past 6months
Patients with unrealistic expectation.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assessed by measuring hair density, hair diameter, hair count per follicular unit, interfollicular distance, serial photographic assessment |
every month for 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| subjective satisfaction will be assessed by patients self assessment through the following set of questionnaries. |
after 6 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 |
|
Date of First Enrollment (India)
|
02/09/2024 |
| 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="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
|
A non blinded randomized control trial Male patients with androgenetic alopecia of age between 18 and 45 years willing to take part in the study are included and split into two groups. one group will be advised to apply topical 5% minoxidil alone and other group will be advised to apply topical sulfotransferase(SULT1A1) enzyme booster followed by topical 5% minoxidil. after 6 months analysis will be done whether applying sulfotransferase(SULT1A1) enzyme booster prior to 5% minoxidil improves hair growth significantly. |