| CTRI Number |
CTRI/2019/06/019584 [Registered on: 10/06/2019] Trial Registered Prospectively |
| Last Modified On: |
30/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [N/AP] |
| Study Design |
Other |
|
Public Title of Study
|
Safety assessment of products on skin |
|
Scientific Title of Study
|
Evaluation of the irritation potential of Skin and Hair Care Formulations on healthy human subjects. |
| Trial Acronym |
Not Applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q02-FA-MY19, Version: 01, Dated: 23/05/2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Siddheshwar Mathpati |
| Designation |
Investigator |
| Affiliation |
Mascot-Spincontrol India Pvt. Ltd. |
| Address |
Mascot Spincontrol India Pvt. Ltd Unit No.2, Neeru Silk Mills, Mathuradas Mills Compound, N.M Joshi Marg, Lower Parel, Mumbai.
Mumbai (Suburban)
Mumbai (Suburban)
MAHARASHTRA
400013
India |
| Phone |
|
| Fax |
|
| Email |
siddheshwar@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddheshwar Mathpati |
| Designation |
Investigator |
| Affiliation |
Mascot-Spincontrol India Pvt. Ltd. |
| Address |
Mascot Spincontrol India Pvt. Ltd Unit No.2, Neeru Silk Mills, Mathuradas Mills Compound, N.M Joshi Marg, Lower Parel, Mumbai.
Mumbai (Suburban)
Mumbai (Suburban)
MAHARASHTRA
400013
India |
| Phone |
|
| Fax |
|
| Email |
siddheshwar@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
Mascot Spincontrol India Pvt. Ltd. |
| Address |
Mascot Spincontrol India Pvt. Ltd Unit No.2, Neeru Silk Mills, Mathuradas Mills Compound, N.M Joshi Marg, Lower Parel, Mumbai.
Mumbai (Suburban)
Mumbai (Suburban)
MAHARASHTRA
400013
India |
| Phone |
|
| Fax |
|
| Email |
mohit@mascotspincontrol.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mountain Valley Springs India Pvt Ltd |
| Address |
Mountain Valley Springs India Pvt Ltd
E-46 & 47,I.A,
Bahadrabad, Haridwar,
Uttarakhand-249402, INDIA |
| Type of Sponsor |
Other [FMCG] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
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 Siddheshwar Mathpati |
Mascot Spincontrol India Pvt. Ltd. |
Unit 2, Neeru Silk Mills, Mathuradas Mill compound, N.M. Joshi Marg - Lower Parel, Mumbai-400013
Mumbai (Suburban)
Mumbai (Suburban)
MAHARASHTRA |
022-43349191
siddheshwar@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 |
Volunteer of all skin types |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1)(00527DG): Aerosol
2)(00730DG): Liquid
3)(00928CG): Aerosol
4)(B19001): Liquid
5)(00506DG): Cream
6) (00912DG): Cream
7)(00529CG): Cream
8)(00502EG): Cream
9)(00407EG): Cream
10)(01122DG): Liquid
11)(B19001): Cream
12)(00404EG): Cream
13)(00402EG): Emulsion
14)(00823DG): Cream
16)(00630DG): Emulsion
17)(00426DG): Emulsion
18) (00427DG): Emulsion
19) (00226CG): Cream
20) (00430DG): Emulsion
21) (00706EG): Emulsion
22) (00427DG): Cream
23) (00904EG): Emulsion
24) (00813DG): Cream
25) (00727DG): Oil
26) (00820DG): Oil |
a)Procedure for Patch Preparation of 9(00527DG):Product A, 21(00730DG) : Product B, 23 (00928CG) : Product C as per BIS Standard clause 4.3.1.2, IS 4011:2018, 3rd Revision:
For the ease of procedures, the technique is modified as below:
1cm2 disc of Whattman no. 3 filter paper will be placed on the back of subjects.
0.02 ml or 20 μl of test product will be loaded onto the filter paper disc in a dropwise manner and let to evaporate prior to loading the remaining 0.02 ml or 20 μl of test product in a similar manner.
Once the product gets completely evaporated, the Whattman no. 3 filter paper will be lifted and the site will be left as it is for upto half an hour prior to occluding the patch.
b) Procedure for Patch Preparation of 26(00506DG):Product E, 11(00912DG):Product F, 12(00529CG): Product G, 13(00502EG): Product H, 14(00407EG): Product I, 24 (B19001): Product K, 25 (00404EG) : Product L as per BIS Standard clause 4.3.1.2, IS 4011:2018, 3rd Revision:
Measure 0.04 ml (40 μl) of test sample with the help of 1ml of Syringe.
Transfer the test products on previously numbered Aluminium Finn Chamber, with the help of Syringe.
The Finn chambers with the product loaded filter paper discs will then be taped onto the back of subjects.
c) Procedure for Patch Preparation of 8(B19001):Product D, 16(01122DG): Product J 10(00727DG): Product X, 27(00820DG): Product Y as per BIS Standard clause 4.3.1.2, IS 4011:2018, 3rd Revision:
Measure 0.04 ml (40 μl) of test sample with the help of Micropipette.
Transfer the test products on previously numbered Aluminium Finn Chamber, with an appropriate sized disk of Whatman no. 3 filter paper with the help of Micropipette.
d) Procedure for Patch Preparation of
22(00402EG): Product M, 20(00823DG): Product N, 2(00630DG):Product O, 3(00426DG) :Product P, 4(00427DG) : Product Q, 5(00226CG): Product R, 6(00430DG): Product S, 7 (00706EG): Product T, 15(00427DG): Product U, 18 (00904EG): Product V, 19(00813DG): Product W, as per BIS Standard clause 4.3.1.2, IS 4011:2018, 3rd Revision:
8% w/w solution of the investigational product will be prepared by weighing 2g of the product and dissolving it in distilled water and making up the final weight to 25g.
0.04 ml or 40 μl of the prepared sample will be loaded onto the filter paper disc.
The Finn chambers with the product loaded filter paper discs will then be taped onto the back of subjects. |
| Comparator Agent |
Sodium Lauryl Sulphate (SLS) |
e)Patch preparation for Negative control
For Leave on: as per BIS Standard clause 4.3.1.2.4, IS 4011:2018, 3rd Revision:
40 μl of 0.9% isotonic saline solution is transferred to previously numbered Aluminium Finn Chamber with an appropriate sized disk of Whattman No. 3 filter paper with the help of Micropipette.
f)Patch preparation for Positive control
For Leave On: as per BIS Standard clause 4.3.1.2.4, IS 4011:2018, 3rd Revision:
Sodium Lauryl Sulphate solution: 1% w/w solution in distilled water is prepared and 40 μl of this solution is applied on an appropriate sized disk of Whattman No. 3 filter paper is placed in aluminum Finn chambers prefixed on micro pore tape. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) 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)
2) Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
|
|
| ExclusionCriteria |
| Details |
For female : Being pregnant or breastfeeding or having stopped to breastfeed in the past three months, Having refused to give his/her assent by signing the consent form, Taking part in another study liable to interfere with this study Being diabetic, Being asthmatic, Having eczema, oriasis, lichen plan, vitiligo whatever the considered area, Having disorder of the healing (whatever the considered area),Having a rhinitis, allergic conjunctivitis or rhinosinusitis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety assessment of products |
Baseline,0 hrs,24 hrs&7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "23"
Final Enrollment numbers achieved (India)="23" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/06/2019 |
| Date of Study Completion (India) |
20/06/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Single Application Semi occlusive, Closed Patch test is conducted to measure the irritation potential of cosmetic products on the skin Objective: 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) 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 24 healthy subjects (12 males + 12 females) The test area is checked for erythema and oedema caused due to the products and compared with positive control. |