| CTRI Number |
CTRI/2023/11/060028 [Registered on: 20/11/2023] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to check hair fall benefits |
|
Scientific Title of Study
|
To evaluate the efficacy of the test product in comparison to baseline in improving hair growth rate and hair fall reduction in healthy subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HAIR/MAHS/2023-05 Version 1.0 dated 17 Oct 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mukesh Ramnane |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
327/15, 1st Main Road, Cambridge Layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
mukesh.ramnane@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mukesh Ramnane |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
327/15, 1st Main Road, Cambridge Layout, Ulsoor
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
mukesh.ramnane@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Mukesh Ramnane |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
327/15, 1st Main Road, Cambridge Layout, Ulsoor
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
mukesh.ramnane@msclinical.com |
|
|
Source of Monetary or Material Support
|
| Marico Limited
MARKS, plot no:23-C
Mahakalli Caves Road
Andheri (E)
Mumbai-400093 |
|
|
Primary Sponsor
|
| Name |
Marico Limited |
| Address |
MARKS, plot no:23-C Mahakalli Caves Road Andheri (E) Mumbai-400093 |
| Type of Sponsor |
Other [FMCG (Fast moving Consumer Goods)] |
|
|
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 |
MS Clinical Research Pvt. Ltd |
2nd Floor, Hair department,
327/15, 1st Main Road, Cambridge Layout, Ulsoor
Bangalore
KARNATAKA |
08041125934
08040917253
mukesh.ramnane@msclinical.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinicom Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy male and female subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
RS-2 |
Apply the required quantity while making small partition across the scalp. Start from front and move to the back for uniform application.
Leave the oil overnight and wash the next day with the provided shampoo.
The study will be for approximately 14 weeks for each subject including 2 weeks of wash out period.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1) Male and female subjects in general good health.
2) Subjects in the age group 18-45 years (both the ages inclusive).
3) Subjects complaining of hair fall and damage.
4) Subjects willing to give a written informed consent and willing to abide by and comply with the study protocol.
5) Hair density of >100 and <200 hair follicle per square cm as per Trichoscan measurement.
6) Male and female subjects falling under Grade 3 - Grade 6 of hair loss severity grade evaluated as per photo numerical 10-point scale (Linear scale for assessment purpose-In Use Scale).
|
|
| ExclusionCriteria |
| Details |
1) Subjects who have undergone hair growth treatment within 3 months before screening into the study.
2) Subjects having any active scalp disease which may interfere in the study – dermatologist’s judgement.
3) Subjects who have taken chemotherapy for cancer in the 6 months prior to start of the study or have a plan to do treatments during study.
4) Subjects who have history of alcoholism, smoking, crash dieting and/ or psychiatric disorder including trichotillomania.
5) Subjects who have had hair transplant, who have taken pharmaceutical product which cause hirsutism (ex. phenytoin) and finesteride for androgenic alopecia, under medical treatment for hair problems.
6) A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
7) Subjects on oral medications, undergoing any chemical hair salon treatment-straightening / perming / colour/ henna which will compromise the study.
8) Subjects with chronic illness which may influence the cutaneous state.
9) Subjects participating in other similar cosmetic or therapeutic trial within last three months.
10) Subjects with any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Significant improvement in hair growth rate.
2.Significant improvement in hair thickness.
3.Significant reduction in hair fall count.
4.Significant improvement in hair density
5.Significant improvement in anagen and telogen ratio |
At Week 2, Week 4, Week 8 & Week 12 in comparison to baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Significant improvement in hair thinning.
2.Significant improvement in density of vellus hair and terminal hair.
3.overall safety of test product. |
At Week 2, Week 4, Week 8 & Week 12 in comparison to baseline. |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="38" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
21/11/2023 |
| Date of Study Completion (India) |
29/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Adult male and female subjects with age between 18-45 years (both inclusive) will be screened for eligibility criteria. On screening visit, before starting any study procedure, written informed consent will be obtained. All baseline assessment like baseline dermatological assessments and imaging will be performed. Post baseline assessments, the selected subjects will be provided with the test product. The subjects will be instructed to use the test product for 90/92 days. Follow up evaluations will be performed at day 14 & 16, day 30 & 32, day 60 and 62 and day 90 & 92. |