| CTRI Number |
CTRI/2023/10/058576 [Registered on: 12/10/2023] Trial Registered Prospectively |
| Last Modified On: |
31/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety and Efficacy assessment of cosmetic product |
|
Scientific Title of Study
|
To evaluate invivo safety and efficacy of a Hair care formulation in terms of reduction in dandruff after one wash on healthy human subject |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-XI01-MW-SR23; Version: 01; Dated: 30/09/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raji Patil |
| Designation |
Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raji Patil |
| Designation |
Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mosaic wellness pvt ltd , 7th floor, Skyline icon, Chimatpada,Marol, Andheri, Mumbai-400059. |
|
|
Primary Sponsor
|
| Name |
Mosaic wellness pvt ltd |
| Address |
Mosaic wellness pvt ltd , 7th floor, Skyline icon, Chimatpada,Marol, Andheri, Mumbai-400059. |
| 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 Raji Patil |
Mascot Spincontrol India Pvt. Ltd. |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai
Mumbai
MAHARASHTRA |
02243349191
raji@mascotspincontrol.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethos- An Institutional Ethics committee (Mumbai) |
Approved |
| Ethos- An Institutional Ethics committee (Mumbai) |
Approved |
| Ethos- An Institutional Ethics committee (Mumbai) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
having mild to moderate dandruff |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Not applicable |
| Intervention |
Shampoo |
Hair are washed with the sufficient amount of shampoo. this application is done only once at site for the period of 48 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1 Indian / Asian male and female subjects.
2 Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup)
3 Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
4 Having mild to moderate dandruff.
|
|
| ExclusionCriteria |
| Details |
1 For female: 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 is 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 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products
11 Following a chronic or intermittent medicinal treatment comprising any of the following products :aspirin-based products, anti-inflammatories, anti-histamines, anti-coagulants, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)
12 Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months
13 Having changed his/her cosmetic habits except those required by the protocol in the 3 days preceding the start of the study on the studied anatomic unit
14 Having applied a hair care products and cosmetic products on the studied area the first day of the study (except hair washed with the provided neutral shampoo one day prior to the day of visit.)
15 Having applied a hair care product on study visits including test products.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in dandruff after one wash |
Baseline, 24 hours after application, 48 hours after application |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Not applicable |
|
|
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)
|
18/10/2023 |
| 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="0"
Days="15" |
|
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
Modification(s)
|
OBJECTIVE :The objective
of this study will be to evaluate invivo safety and efficacy of a Hair care
regime in terms of reduction in dandruff after two washes on healthy human
subject.
The evaluation is performed using:Subject’s Self Evaluation,
Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation:
Efficacy
The study lasts 7 days including the 2 days
conditioning phase and 5 days treatment period.
POPULATION : 36 subjects (18
male & 18 female) are selected for the study.
The subjects selected for this
study are healthy male & female subjects aged between 18 and 35 years old,
having mild to moderate dandruff
Test Products: Regime with Anti Dandruff Lotion
and Anti Dandruff Shampoo
Anti Dandruff lotion will be applied once at night
on day 1 (T0) and day 4(T+3 days).
Anti dandruff shampoo will be used once in a day on
whole scalp on day 2(T+1 day) and day 5(T+4 days).
|