| CTRI Number |
CTRI/2025/06/088094 [Registered on: 02/06/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal] |
| Study Design |
Other |
|
Public Title of Study
|
Study to evaluate the safety of cosmetic products on human volunteers |
|
Scientific Title of Study
|
Evaluation of the irritation potential of Skin, Hair and Baby Care Formulations on healthy minor subjects |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q01-4B-AL25; Version: 01; Dated: 15/04/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Yadav |
| 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 |
poojayadav@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Yadav |
| 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 |
poojayadav@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
|
| Bespoke Bath
(Pure Education Ventures Pvt Ltd)
2nd cross road, HIG sector,
RMV Extension 2nd stage, Bengaluru
|
|
|
Primary Sponsor
|
| Name |
Bespoke Bath (Pure Education Ventures Pvt Ltd) |
| Address |
2nd cross road, HIG sector,
RMV Extension 2nd stage, Bengaluru
|
| Type of Sponsor |
Other [Non-government company ] |
|
|
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 Pooja Yadav |
Mascot Spincontrol India Pvt. Ltd. |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA |
02243349191
poojayadav@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 |
With healthy skin on studied anatomic unit |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hair oil |
Single application of about 0.04ml of product is applied under occlusion for 24hrs on the subjects back. The patch will keep as it is for 24 hours and removed after that. |
| Intervention |
kids conditioner |
A single application of about 0.04ml of 8% w/w of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. The patch will keep as it is for 24 hours and removed after that. |
| Intervention |
kids facewash |
A single application of about 0.04ml of 8% w/w of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. The patch will keep as it is for 24 hours and removed after that. |
| Intervention |
kids handwash |
A single application of about 0.04ml of 8% w/w of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. The patch will keep as it is for 24 hours and removed after that. |
| Intervention |
kids lotion+spf |
Single application of about 0.04ml of product is applied under occlusion for 24hrs on the subjects back. The patch will keep as it is for 24 hours and removed after that. |
| Intervention |
kids shampoo |
A single application of about 0.04ml of 8% w/w of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. The patch will keep as it is for 24 hours and removed after that. |
| Intervention |
Kids wash |
A single application of about 0.04ml of 8% w/w of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. The patch will keep as it is for 24 hours and removed after that. |
| Intervention |
Lip Balm |
Single application of about 0.04ml of product is applied under occlusion for 24hrs on the subjects back. The patch will keep as it is for 24 hours and removed after that. |
| Comparator Agent |
Negative Control (0.9 percent Isotonic saline solution) |
single application of about 0.04ml of 0.9% Isotonic Saline, is applied under occlusion for 24hrs on the subjects back.The patch will keep as it is for 24 hours and removed after that. |
| Comparator Agent |
Positive Control (1 percent w/w SLS) |
A single application of about 0.04ml of 1 percent SLS, prepared in distilled water is applied under occlusion for 24hrs on the subjects back. The patch will keep as it is for 24 hours and removed after that. |
| Intervention |
Rose mist |
Single application of about 0.04ml of product is applied under occlusion for 24hrs on the subjects back. The patch will keep as it is for 24 hours and removed after that. |
| Intervention |
sunscreen |
Single application of about 0.04ml of product is applied under occlusion for 24hrs on the subjects back. The patch will keep as it is for 24 hours and removed after that. |
| Intervention |
Talcum |
Single application of about 0.04ml of 1:1 solution of the investigational product and distilled water is applied under occlusion for 24hrs on the subjects back. The patch will keep as it is for 24 hours and removed after that. |
| Intervention |
Tummy Roll -On |
Single application of about 0.04ml of product is applied under occlusion for 24hrs on the subjects back. The patch will keep as it is for 24 hours and removed after that. |
| Intervention |
Ubtan |
A single application of about 0.04ml of 8% w/w of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. The patch will keep as it is for 24 hours and removed after that. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1) Healthy Human Subjects
2) Skin should be healthy on the studied anatomic unit |
|
| ExclusionCriteria |
| Details |
1)Having refused to give his/her assent by not signing the consent form.
2)Taking part in another study liable to interfere with this study.
3) Being diabetic.
4) Being asthmatic.
5) Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
6)Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin).
7) Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
8) Having undergone a surgery requiring a general anesthesia of more than one hour in the past 6 months.
9) Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dermatological safety / Irritation potential on skin |
Baseline,0 hrs,24 hrs and 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
13/06/2025 |
| 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="0"
Days="9" |
|
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 irritation potential on healthy minor subjects of Skin,
Hair and Baby Care Formulations Duration of study: 8 days study Kinetics: T0 (Evaluation of test sites by Dermatologist, Patch application) ,T1(Patch removal, Evaluation of test sites by Dermatologist ,T2(Evaluation of test sites by Dermatologist and Subject post 24 hrs of patch removal), T8 (Evaluation of test sites by Dermat and Subject post 1 week of patch removal and tracking the positive cases) Population: 26 healthy subjects (13 males + 13 females) . The test area is checked for erythema and oedema caused due to the products and compared with positive control |