| CTRI Number |
CTRI/2025/07/090382 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Hair growth and anti-grey study] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate the effect of a scalp lotion in reducing grey hair and promoting hair growth in women over 6 months. |
|
Scientific Title of Study
|
A clinical study to evaluate the anti-grey and hair growth efficacy of a scalp lotion
in female subjects over 6 months. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HAIR/ICHS/2025-02 version 1.0 dated 30 May 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ritambhara |
| Designation |
Director business and operation |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
ritambhara@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Sudhanthiran S |
| Designation |
Manager - Techno-commercial |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
sudhan@msclinical.com |
|
|
Source of Monetary or Material Support
|
| Ichimaru Pharcos Co Ltd,
318-1 Asagi, Motosu-Shi
Gifu 501-0475
Japan |
|
|
Primary Sponsor
|
| Name |
Ichimaru Pharcos Co Ltd. |
| Address |
318-1 Asagi, Motosu-Shi
Gifu 501-0475
Japan
|
| Type of Sponsor |
Other [Cosmetic industry] |
|
|
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 Mukta Sachdev |
MS Clinical Research Pvt. Ltd |
327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA |
8040917253
mukta.sachdev@msclinical.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Female subjects with grey hair and hair fall |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Scalp lotion |
The product should be applied by the subject at home twice daily, once in the morning and once at night for a duration of 6 months. Each time, ten pumps of the test product should be evenly distributed across the entire scalp, followed by a thorough one-minute scalp massage. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1. Female subjects in general good health.
2. Female subjects in the age group 30 to 55 years (both the ages inclusive)
3. Subjects willing to give a written informed consent and agree to come for a regular follow up visit.
4. Subjects falling under Grade 3 to Grade 6 of hair loss severity grade evaluated as per photo numeric 10 point scale (MSCR Scale).
5. Subjects with 15-25% of grey hair (considering overall scalp area) based on dermatologist discretion.
6. Subjects who are non-regular users of hair colour or hair dye and have not applied henna or hair colour etc for the past 1 month or more before screening visit (self-declared).
7. Subjects willing to apply TP as per instruction and they will not use any other hair product during the study period.
8. Subjects complaining of hair fall and damage. |
|
| ExclusionCriteria |
| Details |
1. Subjects who have undergone hair growth treatment within 1 month before screening into the study.
2. Subjects using medicated oil/shampoo etc. for treatment of grey hair/ hair fall will be excluded
3. Subjects having any active scalp disease which may interfere in the study – dermatologist’s judgement.
4. Subjects who have taken chemotherapy for cancer in the last 6 months prior to start of the study or have a plan to do treatments during study.
5. Subjects who have history of alcoholism and/or psychiatric disorder including trichotillomania.
6. Subjects who have had hair transplant.
7. A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
8. Subjects on oral medications which will compromise the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Reduction in grey hair (%) in comparison to baseline by cutiscope imaging, trichoscan analysis & dermatological evaluation at 3-months’ and 6-months’ time points compared to baseline.
2. Improvement in hair growth by cutiscope imaging, trichoscan analysis and dermatological evaluation at 3-months’ and 6-months’ time points compared to baseline.
3. Improvement in hair density and thickness by Deno-lite imaging (caselite) and dermatological evaluation at 3-months’ and 6-months’ time points compared to baseline.
4. Overall improvement in the condition of hair in comparison to baseline.
5. Safety evaluation of test products
|
Baseline, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Overall improvement in the condition of hair in comparison to baseline.
2. Safety evaluation of test products |
Baseline, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
18/07/2025 |
| 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 - NO
|
|
Brief Summary
|
The study aims to evaluate the efficacy and safety of test products in reducing grey hair and improving hair growth and density in healthy female subjects. Each subject will participate for approximately 6 months. Screening and enrollment will be based on inclusion/exclusion criteria. Dermatological and instrumental assessments will measure grey hair percentage and hair density. Qualified subjects will undergo a washout period, with evaluations at baseline, 3 months, and 6 months. |