| CTRI Number |
CTRI/2025/09/094465 [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 Dandruff Reduction |
|
Scientific Title of Study
|
To evaluate the in-vivo safety and efficacy of hair care regime in terms of anti-dandruff effect on healthy human subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-XI01-2Q-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, Mumbai, Maharashtra
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, Mumbai, Maharashtra
Mumbai
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 |
Subjects having moderate to severe dandruff with an itchy scalp |
|
|
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 28 days. |
| Intervention |
Hydrate Oil |
The product will be applied on whole head thrice a week in the night for 28 days. |
| Comparator Agent |
NIL |
NA |
| Intervention |
Shampoo |
The product will be applied on whole head thrice a week in the morning for 28 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1)Healthy male and female volunteers between 18-35 years of age.
2)Subjects having moderate to severe dandruff with an itchy scalp. |
|
| 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 |
| Reduction in Dandruff |
T-14 days, T0, T+14 days & T+28 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="1"
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 the in-vivo safety and efficacy of hair care regime in terms of
anti-dandruff effect on healthy human subjects. Kinetics: T-14 days, T0, T+14 days & T+28 days Population: 36 healthy human subjects (18 males + 18 females). The subjects selected for this study are healthy males and females aged between 18 and 35 years, having moderate to severe dandruff with
an itchy scalp.
STUDY DURATION: 42 days
including the 14 days conditioning phase and 28 days treatment phase. |