| CTRI Number |
CTRI/2024/03/064879 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
22/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to assess hair growth |
|
Scientific Title of Study
|
A pilot study to evaluate the safety and efficacy of serums in improving hair growth in female subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HAIR/AVHG/2024-01 Version 1.0 Dated 06 Mar 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukesh Ramnane |
| Designation |
Principal Investigator |
| Affiliation |
M S Clinical Research |
| Address |
MS Clinical Research Pvt. Ltd,
327 15, 2nd Floor, Hair Department
1st Main Road, Cambridge layout
Ulsoor, Bangalore-560008,
Karnataka, India
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
mukesh.ramnane@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh Ramnane |
| Designation |
Principal Investigator |
| Affiliation |
M S Clinical Research |
| Address |
MS Clinical Research Pvt. Ltd,
327 15, 2nd Floor, Hair Department
1st Main Road, Cambridge layout
Ulsoor, Bangalore-560008,
Karnataka, India
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
mukesh.ramnane@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh Ramnane |
| Designation |
Principal Investigator |
| Affiliation |
M S Clinical Research |
| Address |
MS Clinical Research Pvt. Ltd,
327 15, 2nd Floor, Hair Department
1st Main Road, Cambridge layout
Ulsoor, Bangalore-560008,
Karnataka, India
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
mukesh.ramnane@msclinical.com |
|
|
Source of Monetary or Material Support
|
| AVT Natural Pproducts Limited |
|
|
Primary Sponsor
|
| Name |
AVT Natural Products Limited |
| Address |
Plot.No225 1A 5-7, S Vazhakulam,
Marampilly P.O
Aluva-Cochin
683105 Kerala
India
|
| Type of Sponsor |
Other [FMCG] |
|
|
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 Mukesh Ramnane |
M S Clinical Research |
327/15, 2nd Floor, Hair Department
1st Main Road, Cambridge layout
Ulsoor, Bangalore-560008,
Karnataka, India
Bangalore
KARNATAKA |
08040917253
mukesh.ramnane@msclinical.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinicom |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Female participants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HS-1 |
1ml of HS-1 will be applied twice daily for 12 weeks
|
| Intervention |
HS-2 |
1ml of HS-2 will be applied twice daily for 12 weeks
|
| Comparator Agent |
HS-3 |
1ml of HS-3 will be applied twice daily for 12 weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Subjects complaining of hair fall and damage.
2.Subjects willing to give a written informed consent and willing to abide by and comply with the study protocol.
3.Hair density of less than 100 and more than 200 hair follicle per square cm as per TrichoScan measurement
4.Female Subjects falling under Grade 3 - Grade 6 of hair loss severity grade evaluated as per MSCR photo numerical 10-point scale |
|
| ExclusionCriteria |
| Details |
1 Subjects who have undergone any kind of hair growth treatment in the last 3 months
2 Subjects having any active but controllable scalp disease which may interfere in the study assessments
3 Subjects who have taken chemotherapy for cancer in the 6 months prior to the studys start
4 Subjects who have history of crash dieting and or psychiatric disorder including trichotillomania
5 Subjects who have undergone hair transplant
6 A known history or present condition of allergic response or hypersensitivity to any topical or oral cosmetic pharmaceutical or nutraceutical product
7 Subjects on oral medications like topical or systemic corticosteroids undergoing any chemical hair salon treatment which will compromise the study
8 Subjects with chronic illness which may influence the cutaneous state
9 Subjects who are pregnant or nursing Self declared
10 Subjects with any history or present of underlying uncontrolled medical illness or any other serious medical illness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare hair growth, thickness, reduction in hair fall after use of the test products in comparison to baseline and all time points by dermatological and instrumental assessments. |
Baseline, Week 2, Week 4, Week 8, Week 12 |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 2 |
|
Date of First Enrollment (India)
|
02/04/2024 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The screening phase comprises two visits, D-16 and D-14, where 45 eligible female subjects undergo informed consent, dermatological examination, and TrichoScan® assessment. Subjects discontinue other hair care medications before Visit 1 and return for TrichoScan® at Visit 2. On Day 1 of the treatment phase, subjects are randomized into three groups and receive test products (HS-1, HS-2, or HS-3). Baseline assessments are conducted, followed by subsequent visits for various assessments, including phototrichogram and Sebufix on Visioscan Camera on Day 3. Follow-up assessments occur at intervals of 30, 60, and 90 days, with subject self-assessment at specified visits and retrieval of test products and diaries at Day 62. |