| CTRI Number |
CTRI/2023/09/057658 [Registered on: 14/09/2023] Trial Registered Prospectively |
| Last Modified On: |
12/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Skin care formulations] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of safety of cosmetic product |
|
Scientific Title of Study
|
The objective of this study will be to evaluate the sensitization potential of Skin Care formulations on healthy human subjects. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q19-TI-JY23; Version: 01; Dated: 24/08/2023 |
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 |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West,
Mumbai.
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Satyendra Kumar |
| Designation |
Sr. Manager - Clinical Research |
| Affiliation |
Transformative Learning Solution Pvt. Ltd. |
| Address |
Transformative Learning Solution Pvt. Ltd. 3rd Floor, Veritas Tower,Sector 53
Gurgaon
HARYANA
122002
India |
| Phone |
9891253516 |
| Fax |
|
| Email |
satyendra.kumar@transformative.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 West,
Mumbai.
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| Transformative Learning Solution Pvt Ltd, 3rd Floor, Veritas Tower, Sector 53,Gurugram,
Haryana- 122002 |
|
|
Primary Sponsor
|
| Name |
Transformative Learning Solution Pvt Ltd |
| Address |
3rd Floor, Veritas Tower, Sector 53,Gurugram, Haryana- 122002 |
| 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 |
Kohinoor Estate, 3rd
Floor, Sun Mill
Compound, Lower
Parel West, Mumbai
Mumbai
MAHARASHTRA |
02243349191
raji@mascotspincontrol.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Suraksa- Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Having apparently healthy skin on Test area |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.9% Isotonic Saline Solution - Negative control |
0.9% Isotonic Saline Solution is dispensed in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit. There will be 10 time (9 time in induction phase and 1 time in challenge phase) application and the occluded patch is removed after every 24 hours. |
| Intervention |
TRAHNNA HEART-LEAVED MOONSEED PROTECTIONIST BODY SOOTHER(T-0123) |
0.04 ml or 40 microlitre of the products is dispensed in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit. There will be 10 time (9 time in induction phase and 1 time in challenge phase) application and the occluded patch is removed after every 24 hours. |
| Intervention |
TURMERISA DOUBLE TURMERIC FACIAL ESSENCE(T-0123) |
0.04 ml or 40 microlitre of the products is dispensed in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit. There will be 10 time (9 time in induction phase and 1 time in challenge phase) application and the occluded patch is removed after every 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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 Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
4 Photo type III to V.
5 Having apparently healthy skin on Test area.
6 For whom the Investigator considers that the compliance will be correct.
7 Cooperating informed of the need and duration of the examination and ready to comply with protocol procedures.
8 Having signed a consent form.
9 Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
10 Willingness to avoid excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise sauna…) during the course of the study.
11 Should be able to read and write in English Hindi or local language.
12 Having valid proof of identity and age. |
|
| 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).
12 Scars excessive terminal hair or tattoo on the studied area.
13 Henna tattoo anywhere on the body (in case of studies involving hair dyes).
14 Dermatological infection pathology on the level of studied area.
15 Hypersensitivity allergy antioxidant to any cosmetic product raw material or hair dye.
16 Any clinical significant systematic or cutaneous disease which may interfere with the study treatment or procedure.
17 Chronic illness which may influence the outcome of this study.
18 Subjects on any medical treatment either systematic or topical which may interfere with the performance of the study treatment presently or in the past one month.
19 Subject in an exclusion. Or participating in another food cosmetic or therapeutic trial.
20 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, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol). , Do not change his/her cosmetic habit so yeah s apart from the particular conditions mentioned in the protocol, on the studied anatomic unit |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| sensitization potential |
T2days, T4days, T6days, T9days, T11day, T13days, T16days, T18days, T20days. T25days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
20/09/2023 |
| 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="3"
Days="0" |
|
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
|
The objective of this study is to evaluate the sensitization potential of Skin Care formulation on healthy human subjects Product : TRAHNNA HEART-LEAVED MOONSEED PROTECTIONIST BODY SOOTHER(T-0123): Product A & TURMERISA DOUBLE TURMERIC FACIAL ESSENCE(T-0123): Product B The evaluation is performed using: Dermatological Evaluation: Human Repeat Insult Patch Test Method Total duration of the study: 40 days following the first application of product. Kinetics: Induction phase with 21 visits( T0, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, T12, T13, T14, T15, T16, T17, T18, T19 and T20) then resting phase of 14 days and 5 days of Challenge phase( T21, T22, T23, T24 & T25) The study is conducted in 3 phases:1. Induction Phase, 2.Resting Phase, 3.Challenge Plhase Induction phase is of 21 days and in which 9 repeated applications of patches are carried out which are removed after 24 hours of application and evaluated after 24 hours of patch removal. Resting phase is of 14 days in which no application of any patch is done in order to develop sensitization to the test product. In Challenge phase only one patch is applied which is removed after 24 hours and evaluated after 24 hours 48 hours and 72 hours Number of volunteers: 220 (110 male+110 female) subjects |