| CTRI Number |
CTRI/2019/06/019913 [Registered on: 27/06/2019] Trial Registered Prospectively |
| Last Modified On: |
30/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of irritation potential of products on skin |
|
Scientific Title of Study
|
Evaluation of the irritation potential of Hair care formulations on healthy human subjects |
| Trial Acronym |
Not Applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q01-BA-JE19, Version: 01, Dated: 17/06/2019 |
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 |
Unit 2, Neeru Silk Mills, Mathuradas Mill compound, N.M. Joshi Marg - Lower Parel, Mumbai, INDIA
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, Neeru Silk Mills, Mathuradas Mill compound, N.M. Joshi Marg - Lower Parel, Mumbai, INDIA
Mumbai (Suburban)
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, Neeru Silk Mills, Mathuradas Mill compound, N.M. Joshi Marg - Lower Parel, Mumbai, INDIA
Mumbai (Suburban)
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
mohit@mascotspincontrol.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
TORFO WELLNESS PRIVATE LIMITED |
| Address |
306-307, SSR Corporate Park,
Faridabad
|
| 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, INDIA
Mumbai (Suburban)
MAHARASHTRA |
022-43349191
siddheshwar@mascotspincontrol.in |
|
Details of Ethics Committee
Modification(s)
|
| 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 |
1) Protein Shampoo (RDPS050619)
2) Protein Conditioner (RDPC050619)
3) Anti Dandruff Shampoo (RDADS050619)
4) Anti Dandruff Conditioner (RDADC050619)
5) Anti Pollution Hair Mask (RDHM050619)
6) Anti Hair Fall Oil (RDAHO050619)
7) Anti Dandruff Oil (RDADO0501619)
8) Soy & Wheat Heat Resistant Serum(RDPHS180619)
9) Tea Tree & Apple Cedar Vinegar Antidandruff Serum(RDADS180619) |
1) Procedure for Patch preparation of Protein Shampoo (RDPS050619), Protein Conditioner (RDPC050619), (RDADS050619, Anti Dandruff Conditioner (RDADC050619), Anti Pollution Hair Mask (RDHM050619): Prepare 8% w/w solution of the test sample in distilled water, 0.04 ml (40 μl) of this solution was transferred to previously numbered Aluminum Finn Chamber, with the help of Pipette
2) Patch Preparation of Anti Hair Fall Oil (RDAHO050619), Anti Dandruff Oil (RDADO0501619), Soy & Wheat Heat Resistant Serum (RDPHS180619), Tea Tree & Apple Cedar Vinegar Antidandruff Serum (RDADS180619): Measure 0.04 ml (40 μl) of test sample with the help of Micropipette. Transfer the test products on previously numbered Aluminium Finn Chamber.
|
| Comparator Agent |
Sodium Lauryl Sulphate (SLS): Positive Control and Isotonic Saline Solution: Negative Control |
For POsitive Control: 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 Whatman No. 3 filter paper is placed in aluminum Finn chambers prefixed on micro pore tape.
For Negative Control:
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.
|
|
|
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)
|
08/07/2019 |
| Date of Study Completion (India) |
12/07/2019 |
| 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
|
Not as of now |
|
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 Hair 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. |