| CTRI Number |
CTRI/2024/08/071858 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal ] |
| Study Design |
Other |
|
Public Title of Study
|
Safety check of products on human volunteers |
|
Scientific Title of Study
|
Evaluation of irritation potential of Skin Care formulations on healthy human subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q01-N4-JY24, Version No.: 01, Dated: 09/07/2024 |
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
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
investigators@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
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
investigators@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
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| Naturoshift
2nd floor, No.0, Satti Road Trimohani, Mirzapur,
Uttar Pradesh – 231001 |
|
|
Primary Sponsor
|
| Name |
Naturoshift |
| Address |
2nd floor, No.0, Satti Road Trimohani, Mirzapur,
Uttar Pradesh – 231001 |
| 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 Pooja Yadav |
Mascot Spincontrol India Pvt. Ltd. |
Sea Breeze Building, 9th Floor, AppaSaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai
Mumbai
MAHARASHTRA |
02243349191
investigators@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 |
Healthy skin on the studied anatomic unit |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NATUROSHIFT GOAT MILK & LAVANDER HANDCRAFTED SOAP (240205) |
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. |
| Intervention |
NATUROSHIFT HOLY BASIL HANDCRAFTED SOAP (231008) |
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. |
| Intervention |
NATUROSHIFT KESAR HANDCRAFTED SOAP (240205) |
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. |
| Comparator Agent |
Negative Control
(Distilled Water) |
A single application of about 0.04ml of Distilled Water, is applied under occlusion for 24hrs on the subjects back. |
| Comparator Agent |
Positive Control
(3% w/w SLS) |
A single application of about 0.04ml of 3% SLS, prepared in distilled water is applied under occlusion for 24hrs on the subjects back |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Asian Indian male and female subjects
2) Healthy human 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 check-up)
3) Skin is healthy on the studied anatomic unit (free of eczema,wounds, inflammatory scar….) |
|
| 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 liable to interfere with this study
4 Being diabetic.
5 Being asthmatic.
6 Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
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/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 of test products, Irritation potential of test products |
Baseline, 0 hr , 24 hours & day 8 |
|
|
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
11/08/2024 |
| 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="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 is to evaluate the irritation potential on healthy human subjects of Skin 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 |