| CTRI Number |
CTRI/2026/01/102172 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to check the safety and dandruff control of two hair care products |
|
Scientific Title of Study
|
To evaluate and compare the in vivo safety and efficacy of two hair care formulations in terms of reduction in dandruff effect on healthy human subjects |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-XI02-XK-NR25; Version: 01; Dated: 12/01/2026 |
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
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
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| Glenmark Pharmaceuticals Ltd.
Corporate Enclave, 2nd Floor,
B D Sawant Marg, Chakala,
Off western Express Highway,
Andheri (East), Mumbai – 400099.
|
|
|
Primary Sponsor
|
| Name |
Glenmark Pharmaceuticals Ltd. |
| Address |
Corporate Enclave, 2nd Floor, B D Sawant Marg, Chakala, Off western Express Highway, Andheri (East), Mumbai – 400099. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 |
| Samarth – Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
having moderate to severe dandruff (L21.9) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Head and Shoulders (B5352DI69) |
The test product will be applied Thrice a week to Scalp and Hair shaft and rinsed off with water. The intervention will be continued for 28 days. |
| Comparator Agent |
Nil |
NA |
| Intervention |
SCALP® PRO DAILY ANTI DANDRUFF SHAMPOO (7B250258) |
The test product will be applied Thrice a week to Scalp and Hair shaft and rinsed off with water. The intervention will be continued for 28 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1)Indian Asian male & females subjects.
2)Healthy subjects.
3)Skin is healthy on the studied anatomic unit
4)Having moderate to severe dandruff.
|
|
| ExclusionCriteria |
| Details |
1)For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three
months
2)Having refused to give his/her assent by not signing the consent form
3)Taking part in another study liable to interfere with this study
4)Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area
5)Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less
than 6 months)
6)Having a progressive asthma (either under treatment or last fit in the last 2 years)
7)Being epileptic
8)Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
9)Having cutaneous hypersensitivity
10)Following a chronic or intermittent medicinal treatment comprising any of the following
products: aspirin-based products, anti-inflammatories, antihistamines, anti-coagulants,
corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)
11)Having undergone a surgery requiring a general anaesthetic of more than one hour in the past
6 months
12)Having changed his/ her cosmetic habits except those required by the protocol in the 14 days
preceding the start of the study on the studied anatomic unit
13)Having applied a hair care product on studied area the first day of the study (hair should be washed with the provided neutral shampoo two days prior to the day of visit.)
14)Having applied a hair care product on study visits (hair should be washed with the provided test product two days prior to the day of study visits.)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| safety and reduction in dandruff effect |
Baseline, Day 7, Day 14, Day 28, Day 56 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
07/02/2026 |
| 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
|
OBJECTIVE :The objective of this study will be to evaluate & compare the
in-vivo safety and efficacy of two hair care formulations in terms of reduction
in dandruff effect on healthy human subjects
The evaluation will
be performed using:Subject’s Self Evaluation, Dermatological
Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Corneometry,
Photographs of scalp build-up by Dino-lite
The subjects selected for this study are healthy males & females,
aged between 18 and 35 years old having moderate to severe dandruff (at least shoulder length hair for Females)
STUDY DURATION : 70 days including the 14 days conditioning period, 28 days application
period and 28 days Reoccurrence period.
|