| CTRI Number |
CTRI/2025/09/094464 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [COSMECEUTICALS] |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Hair Care Regime on hair growth |
|
Scientific Title of Study
|
To evaluate the in vivo safety and efficacy of hair care regime in terms of hair growth i.e., improvement in A is to T ratio on healthy human subjects. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-7I01-2Q-JY25; Version 01; Dated 29/08/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Niharika Salian |
| Designation |
Principal Investigator |
| Affiliation |
Mascot Spincontrol India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, AppaSaheb Marathe Marg, Century Bazaar, Prabhadevi,
Sea Breeze Building, 9th Floor, AppaSaheb Marathe Marg, Century Bazaar, Prabhadevi,
Mumbai, Maharashtra 400025, INDIA
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
niharika@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Niharika Salian |
| Designation |
Principal Investigator |
| Affiliation |
Mascot Spincontrol India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, AppaSaheb Marathe Marg, Century Bazaar, Prabhadevi,
Sea Breeze Building, 9th Floor, AppaSaheb Marathe Marg, Century Bazaar, Prabhadevi,
Mumbai, Maharashtra 400025, INDIA
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
niharika@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, AppaSaheb Marathe Marg, Century Bazaar, Prabhadevi,
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| Qi Naturals
Well Chosen Goods Retail Private Limited 58,
Thaneer Pandhal Road, Peelamedu,
Coimbatore - 641004
|
|
|
Primary Sponsor
|
| Name |
Qi Naturals |
| Address |
Qi Naturals
Well Chosen Goods Retail Private Limited 58,
Thaneer Pandhal Road, Peelamedu,
Coimbatore - 641004
|
| 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 Niharika Salian |
Mascot Spincontrol India Pvt. Ltd. |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA |
02243349191
niharika@mascotspincontrol.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethos- An Institutional Ethics committee (Mumbai) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Showing initial stage of baldness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conditioner |
The product will be applied on whole head thrice a week in the morning after washing hair with the shampoo for 84 days. |
| Comparator Agent |
NIL |
NA |
| Intervention |
Nourish Oil |
The product will be applied on whole head thrice a week in the night for 84 days. |
| Intervention |
Shampoo |
The product will be applied on whole head thrice a week in the morning for 84 days. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Healthy male and female volunteers between 30-50 years of age.
2)Subjects showing initial stage of baldness, For Males: Hamilton Scale Class II to III (including III, IIIA and III vertex); for Females: Ludwig Scale I-2 to I-4). |
|
| ExclusionCriteria |
| Details |
1)Volunteer pregnant or planning to become pregnant.
2)Volunteers who are breastfeeding or having stopped to breastfeed in the past three months.
3)Volunteers with any other signs of significant local irritation, erythema or skin disease on scalp as well as on the visible parts of the body skin site.
4)Volunteers having chronic illness or had major surgery in the last year. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Hair Growth |
T0, T+28 days, T+56 days and T+84 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
18/09/2025 |
| 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="3"
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
|
Objective:The objective of this study will be to evaluate in-vivo safety and efficacy of hair care
regime in terms of hair growth i.e., improvement in A:T ratio on healthy human
subjects for regime. Kinetics: T0, T+28
days, T+56 days and T+84 days Population: 36 healthy human subjects (18 males + 18 females). The subjects selected for this study are healthy males and females aged between 30 and 50 years, showing
initial stage of baldness, For Males: Hamilton Scale Class II to III (including III, IIIA and III vertex) ; for Females: Ludwig Scale I-2 to I-4). STUDY DURATION: 84 days following the first application of the product. |