| CTRI Number |
CTRI/2019/05/019272 [Registered on: 23/05/2019] Trial Registered Prospectively |
| Last Modified On: |
08/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
Safety assessment of products on skin |
|
Scientific Title of Study
|
Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin type |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q35-ZC-AL19; Version:01, Dated: 07/05/2019 |
Protocol Number |
| NIL |
NIL |
|
|
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)
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| 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.
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| 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)
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
mohit@mascotspincontrol.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ITC Life Sciences Technology Centre |
| Address |
Peenya Industrial area, I Phase, Peenya Bengaluru, 560058, Karnataka, 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)
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 |
Varied Skin Types |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Product A: Deodorant (9191B)
Product B: Deodorant (9190C)
Product C: Cologne Spray (9188B)
Product D: Perfume Spray (9174A)
Product E: Perfume Spray (9168B)
Product F: Deodorant (9191C)
Product G: Perfume Spray (9168A)
Product H: Deodorant (9191A)
Product I: Perfume Spray (7154D)
Product J: Perfume Spray (7154C)
Product K: Perfume Spray (7154B)
Product L: Perfume Spray (7154A)
Product M: Leave -on (NCFM)
Product N: Shower Gel (98-52)
Product O: Soap (TSP 122-87A)
Product P: Soap (TSP 122-88A)
Product Q: Soap (TSP 122-90C)
Product R: Soap (124-158)
Product S: Soap (124-167)
Product T: Soap (TSP 122-89C) |
a.Procedure for Patch Preparation of Deodorant (9191B): Product A, Deodorant (9190C): Product B, Cologne Spray (9188B): Product C, Perfume Spray (9174A): Product D, Perfume Spray (9168B): Product E, Deodorant (9191C): Product F, Perfume Spray (9168A): Product G, Deodorant (9191A): Product H, Perfume Spray (7154D): Product I, Perfume Spray (7154C): Product J, Perfume Spray (7154B): Product K & Perfume Spray (7154A): Product L
For the ease of procedures, the technique is modified as below:
•1cm2 disc of Whatman No. 3 filter paper will be placed on the back of subjects.
•0.02 ml or 20 μl of test products will be loaded onto the filter paper disc in a dropwise manner and let to evaporate prior to loading the remaining 0.02ml or 20 μl of test products in a similar manner.
• Once the product gets completely evaporated, the Whatman 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 Leave -on (NCFM): Product M
•Remove the mask from the Zip lock cover with clean gloved hands and unfold the 3 layers of sheet.
•Cut the mask with its protective layers (On either sides) into 24 pieces of about 1 sq cm dimension each.
•Detach the non woven sheet before placing the central sheet on the test site and then press it onto the skin gently.
•Remove the white upper plastic layer thereafter and occlude with Aluminum Finn Chamber.
c.Procedure for Patch Preparation of Shower Gel (98-52): Product N, Soap (TSP 122-87A): Product O, Soap (TSP 122-88A): Product P, Soap (TSP 122-90C): Product Q, Soap (124-158): Product R, Soap (124-167): Product S & Soap (TSP 122-89C): Product T
•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) |
Patch preparation for Negative control for Liquid rinse off products
•40 μl of 0.9% Isotonic Saline Solution is transferred to previously numbered Aluminum Finn Chamber with an appropriate sized disk of Whatman no. 3 filter paper with the help of Micropipette.
Patch preparation for Positive control for Liquid rinse off products
•Sodium Lauryl Sulphate solution: 1% w/w solution of SLS in distilled water will be prepared 0.04 ml or 40 μl of the SLS solution will be loaded onto a Whatman filter paper disc, placed in clean Aluminum Finn Chamber.
•Finn chamber with the loaded SLS solution will be taped onto the back of subjects.
Patch preparation for Positive control for soaps
•Sodium Lauryl Sulphate solution: 3% w/w solution of SLS in distilled water will be prepared 0.04 ml or 40 μl of the SLS solution will be loaded onto a Whatman filter paper disc, placed in clean Aluminum Finn Chamber.
•Finn chamber with the loaded SLS solution will be taped onto the back of subject
0.9% Isotonic Saline Solution as Negative control |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
Subjects representing varied skin types (ideally equal representation of all 4 skin types – Oily, Normal, Dry and combination) Subjects willing to come for regular follow up and ready to follow instructions during the study period. |
|
| 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)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/05/2019 |
| Date of Study Completion (India) |
04/06/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
04/06/2019 |
|
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
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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, 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 24 healthy subjects (12 males + 12 females) Products: Product A: Deodorant (9191B) Product B: Deodorant (9190C) Product C: Cologne Spray (9188B) Product D: Perfume Spray (9174A) Product E: Perfume Spray (9168B) Product F: Deodorant (9191C) Product G: Perfume Spray (9168A) Product H: Deodorant (9191A) Product I: Perfume Spray (7154D) Product J: Perfume Spray (7154C) Product K: Perfume Spray (7154B) Product L: Perfume Spray (7154A) Product M: Leave -on (NCFM) Product N: Shower Gel (98-52) Product O: Soap (TSP 122-87A) Product P: Soap (TSP 122-88A) Product Q: Soap (TSP 122-90C) Product R: Soap (124-158) Product S: Soap (124-167) Product T: Soap (TSP 122-89C) Positive control: 1% SLS and 3% SLS. Negative Control: Distilled Water The test area is checked for erythema and oedema caused due to the products and compared with positive control. |