| CTRI Number |
CTRI/2024/02/063257 [Registered on: 28/02/2024] Trial Registered Prospectively |
| Last Modified On: |
23/02/2024 |
| 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 products on skin |
|
Scientific Title of Study
|
Clinical Evaluation of irritation potential of Hair Care formulation on healthy human subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q27-DX-OR23; Version: 01; Dated: 13/02/2024 |
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 |
Kohinoor Estate, 3rd Floor, 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 |
Kohinoor Estate, 3rd Floor, 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 |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel, Mumbai.
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dabur International Limited,
Naturelle LLC, Emirates Link Road
AL Jazira Al Hamra Industrial Area
POBox: 6399, Ras Al Khaimah U.A.E |
|
|
Primary Sponsor
|
| Name |
Dabur International Limited |
| Address |
Naturelle LLC, Emirates Link Road AL Jazira Al Hamra Industrial Area POBox: 6399, Ras Al Khaimah U.A.E |
| 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. |
Kohinoor Estate, 3rd Floor, 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 |
| Comparator Agent |
Negative Control (0.9% Isotonic saline solution) |
40 microliters of 0.9% Isotonic saline solution 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. |
| Comparator Agent |
Positive Control (1% w/w SLS) |
40 microliters of 1% w/w Sodium Lauryl Sulphate isdispensed 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 |
Vatika Henna HAIR COLOUR Henna & Almond (EPV30044) |
1:4 solution of the investigational product is prepared in distilled water. 0.04 ml of test samples is applied on the previously marked area of 3 x 3 cm2 on the inner upper arm. This is a single application, and the product is removed after 30 minutes. |
| Intervention |
Vatika Henna HAIR COLOUR Henna & Blackseed (EPV30118) |
1:4 solution of the investigational product is prepared in distilled water. 0.04 ml of test samples is applied on the previously marked area of 3 x 3 cm2 on the inner upper arm. This is a single application, and the product is removed after 30 minutes. |
| Intervention |
Vatika Henna HAIR COLOUR Henna & Blueberry (EPV20014) |
1:4 solution of the investigational product is prepared in distilled water. 0.04 ml of test samples is applied on the previously marked area of 3 x 3 cm2 on the inner upper arm. This is a single application, and the product is removed after 30 minutes. |
| Intervention |
Vatika Henna HAIR COLOUR Henna & Coffee (EPV30036) |
1:4 solution of the investigational product is prepared in distilled water. 0.04 ml of test samples is applied on the previously marked area of 3 x 3 cm2 on the inner upper arm. This is a single application, and the product is removed after 30 minutes. |
| Intervention |
Vatika Henna HAIR COLOUR Henna & Karkade (EPV30012) |
1:4 solution of the investigational product is prepared in distilled water. 0.04 ml of test samples is applied on the previously marked area of 3 x 3 cm2 on the inner upper arm. This is a single application, and the product is removed after 30 minutes. |
| Intervention |
Vatika Henna HAIR COLOUR Henna & Plum (EPV30005) |
1:4 solution of the investigational product is prepared in distilled water. 0.04 ml of test samples is applied on the previously marked area of 3 x 3 cm2 on the inner upper arm. This is a single application, and the product is removed after 30 minutes. |
| Intervention |
Vatika Henna HAIR COLOUR Henna & Walnut (EPV30002) |
1:4 solution of the investigational product is prepared in distilled water. 0.04 ml of test samples is applied on the previously marked area of 3 x 3 cm2 on the inner upper arm. This is a single application, and the product is removed after 30 minutes. |
|
|
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) Between 18 and 65 years of age
4) Skin is healthy on the studied anatomic unit (free of eczema,wounds, inflammatory scar….)
5)subjects who show no allergic / irritation symptoms to the test product at skin sensitivity test will be enrolled in the study. |
|
| 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.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
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)
|
03/03/2024 |
| 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 clinical study will be to evaluate
the irritation potential on healthy human subjects of Hair Care Formulations.
Duration of study: 8 days study
Kinetics: T-2 day(sensitivity test), 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
product and compared with positive control
|