| CTRI Number |
CTRI/2020/02/023266 [Registered on: 12/02/2020] Trial Registered Prospectively |
| Last Modified On: |
11/02/2020 |
| 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 skin-care products |
|
Scientific Title of Study
|
Evaluation of irritation potential of skin care formulations on healthy human subjects |
| Trial Acronym |
Not Applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q16-TE-JR20 Version No. 01 Dated:24/01/2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manali Mokadam |
| Designation |
Investigator |
| Affiliation |
Mascot Spincontrol India Pvt. Ltd. |
| Address |
Unit 2, Neeru Silk Mills, Mathuradas Mill compound, N.M. Joshi Marg Lower Parel
Mumbai (Suburban)
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
manali@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manali Mokadam |
| Designation |
Investigator |
| Affiliation |
Mascot Spincontrol India Pvt. Ltd. |
| Address |
Unit 2, Neeru Silk Mills, Mathuradas Mill compound, N.M. Joshi Marg Lower Parel
Mumbai (Suburban)
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
manali@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 (Suburban)
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
mohit@mascotspincontrol.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
TTK Healthcare Limited |
| Address |
Research and Development
No.3, Thiruneermalai Road,
Chrompet, Chennai – 600 044
Tamil Nadu, India
|
| Type of Sponsor |
Other [FMCG] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manali Mokadam |
Mascot Spincontrol India Pvt. Ltd. |
Unit 2, Neeru Silk Mills, Mathuradas Mill compound, N.M. Joshi Marg - Lower Parel
Mumbai (Suburban)
MAHARASHTRA |
022-43349191
manali@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 |
Normal Skin Type |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Negative Control (0.9% Isotonic saline solution) Positive Control (1% w/w SLS) |
Patch Preparation of negative control: 40 μl of 0.9% Isotonic Saline Solution will be transferred to Whatman no. 3 filter paper discs in a previously numbered Aluminium Finn Chamber,which will then be taped onto the back of subjects. Patch Preparation of positive control: 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 no. 3 filter paper disc in a previously numbered Aluminium Finn Chamber,which will then be taped onto the back of subjects |
| Intervention |
SKORE Lubes – Chocolate Flavoured Lube
(SLC-002)
SKORE Lubes – Ylang Ylang Flavoured & Scented Lube (SLYY-002) |
Measure 0.04 ml (40 μl) of test sample with the help of syringe.
Transfer test products on previously numbered Aluminium Finn Chamber, with an appropriate sized disk of Whatman no. 3 filter paper with the help of syringe.
The Finn chambers with the products loaded filter paper discs will be taped onto the back of subjects.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Female and male Asian Indian subjects.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)
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 |
Safety assessment of products |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
12/02/2020 |
| 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="0"
Days="8" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |