| CTRI Number |
CTRI/2020/09/027591 [Registered on: 03/09/2020] Trial Registered Prospectively |
| Last Modified On: |
08/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [N/AP] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety assessment of skin care formulation on varied skin type |
|
Scientific Title of Study
|
Evaluation of dermatological safety of investigation products by primary irritation patch test on healthy human volunteers of varied skin types. |
| Trial Acronym |
Not Applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q40-ZC-AT20; Version:01, Dated: 17/08/2020 |
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 |
Unit 2, Mathuradas Mill Compound, Neeru Silk Mills, NM 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 |
Unit 2, Mathuradas Mill Compound, Neeru Silk Mills, NM 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 |
Unit 2, Mathuradas Mill Compound, Neeru Silk Mills, NM 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 Banglore, 560058, Karnataka, India |
| Type of Sponsor |
Other [Indian 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, Mathuradas Mill Compound, Neeru Silk Mills, NM Joshi Marg, Lower Parel, Mumbai
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 Type |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A) Spray (P1, B#10101)
B) Leave-On (B2161352)
C) Wipe (032097a)
D) Liquid (HCL-005-017)
E) Liquid (HCL-006-013)
F) Liquid Rinse-off (LDW-009-071)
G) Rinse-Off (137-69)
H) Liquid Rinse-off (VN B001)
I) Liquid Rinse-off (SXB001)
J) Soap (TSP-123-135) |
1) For product A the product is aerosol, so
will be loaded onto the filter paper disc in a dropwise manner and let to evaporate the patch and applied on the back of the volunteer
2) For product B 0.04 ml (40 μl) of test sample is measured with the help of 1 ml Syringe. and transferred on Aluminium Finn Chamber with filter paper disc, and applied on the back of the volunteers at T0 visit
3) For product C the product is wipe, Cut the 1x1cm of the of test sample
Transfer the test product on previously numbered Aluminium Finn Chamber with the product loaded will then be taped onto the back of subjects
4) For product D the product are diluted 1.5% v/v solution are dispensed in the aluminum chambers of the patch and applied on the back of the volunteers at T0 visit.
5) For product E the product are diluted 0.375% v/v solution are dispensed in the aluminum chambers of the patch and applied on the back of the volunteers at T0 visit.
6) For product F the product are Liquid Rinse-off product will be prepared by weighing 2.5 ml of the product and dissolving it in distilled water and making up the final weight to 25 ml
are dispensed in the aluminum chambers of the patch and applied on the back of the volunteers at T0 visit.
7) For products G, H and I, the products are diluted 8% and solution are dispensed in the aluminum chambers of
the patch and applied on the back of the volunteers at T0 visit.
8) For product J, the product is diluted 8% and solution are dispensed in the aluminum chambers of the patch and applied on the back of the volunteers at T0 visit |
| Comparator Agent |
Positive Control: Sodium Lauryl Sulphate (SLS); Negative Control: Isotonic Solution |
Sodium Lauryl Sulphate (SLS) 1% Solution for leave on products
Sodium Lauryl Sulphate (SLS) 3% Solution for Rinse off products
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 and 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)
|
09/09/2020 |
| Date of Study Completion (India) |
18/09/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
18/09/2020 |
|
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)?
Response - NO
|
|
Brief Summary
|
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) The test area is checked for erythema and oedema caused due to the products and compared with positive control. |