| CTRI Number |
CTRI/2023/07/055274 [Registered on: 17/07/2023] Trial Registered Prospectively |
| Last Modified On: |
14/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceutical] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety evaluation of Oral care formulations |
|
Scientific Title of Study
|
Evaluation of irritation potential of Oral Care formulations on healthy human subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q05-IM-JY23: Version: 01; Dated: 07/07/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raji Patil |
| Designation |
Principal 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
Scientific Query
|
| Name |
Dr Raji Patil |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel
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
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mascot Spincontrol India Pvt. Ltd., 3rd Floor,Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai 400013, MAHARASHTRA India |
|
|
Primary Sponsor
|
| Name |
Aimil Ayouthveda India Limited |
| Address |
B-31, First floor, Dayal kunj, New multan nagar, New Delhi, North West Delhi, Delhi, 110056. |
| Type of Sponsor |
Other [FMCG] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not applicable |
|
|
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 400013
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 |
AYOUTH VEDA AYURVEDIC
TOTAL CARE 360 toothpaste: Product B
|
0.04 ml (40 μl) of test sample will be measured with the help of Weighing Balance. The weighed sample will be applied with the help of a glass rod on a previously marked area of 1 x 1 cms2 on the inner upper arm. This is a single application. The product will be kept as it is on hand for 30 minutes. Then the area will be gently wiped off with soft tissue paper.
|
| Intervention |
AYURVEDIC MINT GEL toothpaste (PD-AMG-01(H)): Product A |
0.04 ml (40 μl) of test sample will be measured with the help of Weighing Balance. The weighed sample will be applied with the help of a glass rod on a previously marked area of 1 x 1 cms2 on the inner upper arm. This is a single application. The product will be kept as it is on hand for 30 minutes. Then the area will be gently wiped off with soft tissue paper.
|
| Comparator Agent |
Negative Control (0.9% Isotonic saline solution) |
40ul of 0.9% Isotonic Saline Solution is transferred on Aluminium Finn Chamber. The Finn chamber with the loaded product will then be taped onto the back of subjects for 24 hours. This is a single application, and the occluded for 24 hours then the patch is removed after 24 hours. |
| Comparator Agent |
Positive Control (1% w/w SLS) |
1% Solution of SLS is prepared in distilled water and is dispensed in the aluminium chamber of the patch and applied on the back of the volunteers at T0 visit for 24 hours. This is a single application and the patch is occluded for 24 hours then the patch is removed after 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Standard criteria
1. Female and male Asian Indian 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 checkup)
3. Between 18 and 65 years of age.
4. 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.
11 The day of the patch application: no cosmetic product must be
used (test site clean with water only). Refusing to follow the
restrictions below during the study: - For female: Do not become
pregnant nor breastfeed. - Do not take part in another study liable to
interfere with this study - Do not take medicinal treatment comprising
any of the following products: aspirin-based products,
anti-inflammatories, and antihistamines, corticotherapy, taken by
general or local routes (the only medication permitted is
paracetamol). - Do not change his/her cosmetic habits apart from the
particular conditions mentioned in the protocol, on the studied
anatomic unit
12 Having eczema, psoriasis, lichen plan, vitiligo whatever the
considered area
13 Having disorder of the healing (whatever the considered area) •
Having a rhinitis, allergic conjunctivitis, or rhino sinusitis
14 Having an allergy to perfumes and/or conservatives in cosmetic
products
15 Having an allergy to plaster
16 Having a food allergy
17 Having a cardiovascular pathology (taking a beta blocker
treatment)
18 Having immunosuppressive drugs, such as cyclophosphamide,
methotrexate, azathioprine, etc.
19 Taking a retinoid-based treatment by general or oral route
20 Taking specific treatment on the back.
21 Having taken an anti-histaminic treatment in the last 2 weeks preceding the start of the study
22 Having miliaria (prickly heat) on the back.
23 Presenting too many naevus on the back
24 Having high pilosity on the back.
25 Refusing to follow the restrictions below during the study: - During the first 24 hours (after patch application), neither cosmetic products nor water must be applied on the back. - Till the follow up period of
until T8 days, only water is accepted from the first reading i.e., T2 days (24 hours after the patch removal). - Do not practice an
intensive sport activity during the first 24 hours (until the removal of the patches) - Do not expose the back to the sun |
|
|
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 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Not applicable |
|
|
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)
|
24/07/2023 |
| 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="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: To evaluate the irritation potential on healthy human subjects with Oral Care Formulations. Duration of study: 8 days study Kinetics: T0 (Evaluation of test sites by Dermatologist, Patch application) T1(Patch removal) 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. |