| CTRI Number |
CTRI/2023/12/060894 [Registered on: 28/12/2023] Trial Registered Prospectively |
| Last Modified On: |
22/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety assessment of cosmetic products |
|
Scientific Title of Study
|
Evaluation of irritation potential of Skin Care & Hair Care formulations on healthy human subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q24-MW-NR23; Version: 01; Dated: 15/12/2023 |
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
|
| 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 |
Normal skin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Be Bodywise 0.3% Retinol Squalene Serum (NJ3248) |
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T0 visit. This is a single application and the occluded patch is removed after 24 hours |
| Intervention |
Be Bodywise 1% Peptide & Ceramide Moisturizer (NJ3210) |
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T0 visit. This is a single application and the occluded patch is removed after 24 hours |
| Intervention |
Be Bodywise 4% AHA BHA Body Butter (NJ3218) |
40 microliters of product is
dispensed on aluminium finn
chambers and then be taped
onto the back of subjects at T0 visit. This is a single application and the occluded patch is removed after 24 hours |
| Intervention |
Be Bodywise 4% AHA BHA Underarm Roll On flora (NJ3203) |
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T0 visit. This is a single application and the occluded patch is removed after 24 hours |
| Intervention |
Be Bodywise 4% AHA BHA Underarm Roll On fragrance free (NJ3261) |
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T0 visit. This is a single application and the occluded patch is removed after 24 hours |
| Intervention |
Be Bodywise 4% AHA BHA Underarm Roll On water melon (NJ3262) |
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T0 visit. This is a single application and the occluded patch is removed after 24 hours |
| Intervention |
Be Bodywise Anti Dandruff serum(BAS002) |
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T0 visit. This is a single application and the occluded patch is removed after 24 hours |
| Intervention |
Be Bodywise Pigmentation Repair Lip Balm SPF 30 (NJ3206) |
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T0 visit. This is a single application and the occluded patch is removed after 24 hours |
| Intervention |
Be Bodywise Sunscreen Gel with SPF 50 (NJ3205) |
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T0 visit. This is a single application and the occluded patch is removed after 24 hours |
| Intervention |
Man Matters DHT Blocking Shampoo(NJ3215) |
The product is rinse off product. 8% solution of the investigational products is prepared in distilled water. The prepared sample is loaded onto the filter paper disc in the aluminium chambers of the
patch and applied on the back
of the volunteers at T0 visit
.This is a single application and the occluded patch is removed after 24 hours |
| Comparator Agent |
Negative Control (0.9% Isotonic
saline solution |
40 ml of 0.9% Isotonic Saline
Solution is transferred on
Aluminium Finn Chamber. The
Finn chambers with the loaded
products will then be taped onto the back of subjects. This is a single application, and the occluded patch is removed after 24 hours. |
| Comparator Agent |
Positive Control (1% SLS) |
1% Solution of SLS is prepared
in distilled water and is dispensed in the aluminium
chambers of the patch and
applied on the back of the
volunteers at T0 visit. This is a single application and the occluded patch is removed after 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Healthy Human Subjects
2) Skin should be healthy on the
studied anatomic unit (free of eczema, wounds, inflammatory
scar….).
3) Subjects willing to come for regular follow up and
ready to follow instructions during the study period.
4) Subjects
representing varied skin types (ideally equal representation of all 4
skin types – Oily, Normal, Dry and Combination) |
|
| 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 or her assent by not signing the consent form
3 Taking part in another study liable to interfere with this study
4 Being diabetic.
5 Being asthmatic.
6 Following a chronic medicinal treatment
7 Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin).
8 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
9 Having undergone a surgery requiring a general anaesthesia of more than one hour in the past 6 months.
10 Having changed his or 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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dermatological safety or 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)
|
01/01/2024 |
| 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="8" |
|
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 human subjects with Skin and Hair 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) with varied skin types.
The test area is checked for erythema and oedema caused due to the products and compared with positive control |