| CTRI Number |
CTRI/2018/02/012199 [Registered on: 28/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
23/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
safety & efficacy of skin care formulation |
|
Scientific Title of Study
|
To evaluate the in-vivo safety & efficacy of Skin care formulation on healthy female subjects of varied eye conditions (Normal Condition, Sensitive Condition & Contact Lens Users) and varied skin conditions (Normal, Oily, Dry & Combination) in terms of makeup removal formulation. |
| Trial Acronym |
not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 02/032/16 v01 08 08 2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Janki K |
| Designation |
investigator |
| Affiliation |
not applicable |
| Address |
MASCOT-SPINCONTROL India Pvt. Ltd.,
Unit 2, Neeru Silk Mills,
Mathuradas Mill compound,
N.M. Joshi Marg - Lower Parel,
Mumbai – 400013, INDIA
Mumbai
MAHARASHTRA
400013
India |
| Phone |
|
| Fax |
|
| Email |
janaki@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Janki K |
| Designation |
investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
MASCOT-SPINCONTROL India Pvt. Ltd.
Unit 2, Neeru Silk Mills,
Mathuradas Mill compound,
N.M. Joshi Marg - Lower Parel,
Mumbai – 400013, INDIA
Mumbai
MAHARASHTRA
400013
India |
| Phone |
|
| Fax |
|
| Email |
janaki@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 2, Neeru Silk Mills,
Mathuradas Mill compound,
N.M. Joshi Marg - Lower Parel,
Mumbai – 400013, INDIA
Mumbai
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
mohit@mascotspincontrol.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ITC LIMITED ITC Life Sciences and Technology Centre |
| Address |
ITC Life Sciences and Technology Centre,
No. 3, 1st Main Road,
Peenya Industrial Area, I Phase Peenya,
Bangalore – 560058, INDIA |
| Type of Sponsor |
Other [Multinational] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| 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 Janaki |
MASCOT-SPINCONTROL India Pvt. Ltd. |
MASCOT-SPINCONTROL India Pvt. Ltd.
Unit 2, Neeru Silk Mills,
Mathuradas Mill compound,
N.M. Joshi Marg - Lower Parel,
Mumbai – 400013, INDIA
Mumbai
MAHARASHTRA |
022-43349191
janaki@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 |
healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bi-phasic Make-up Remover |
Shake the test product well before use to allow uniform mixing of two layers, identifiable by appearance change from transparent to opaque. Take approximately 10 - 15 drops of Product A on cleansing pad. Swab the product gently on whole face including the eye area (upper and lower eye lids, canthal area), cheeks and lips. Spread test product using only cleansing pad in outward direction & remove the applied make up. Ensure that you dont rub the product into your skin. |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Skin is healthy (free of eczema, wounds, inflammatory scar….)
Healthy 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)
female volunteers in the age group of 18 to 40 .
Subjects representing varied skin types (ideally equal representation of all 4 skin types – Oily, Normal, Dry and combination)
Subjects representing varied eye conditions (ideally equal representation of Normal Condition, Sensitive Condition, and Contact Lens Users).
Volunteer Habitual of applying makeup.
Volunteer Habitual waterproof make up.
Female.
|
|
| ExclusionCriteria |
| Details |
Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
Having refused to give her assent by not signing the consent form
Volunteer Taking part in another study liable to interfere with this study
Volunteer Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months)
Volunteer Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products or to latex
Having a progressive asthma (either under treatment or last fit in the last 2 years)
Volunteer Being epileptic
Volunteer Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
Volunteer Having cutaneous hypersensitivity.
Volunteer Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
Volunteer Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
Volunteer Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
Having applied a cosmetic product (included make-up) on the studied areas the first day of the study
Volunteer Having ocular problems (stye, chalazion, conjunctivitis).
Volunteer Having known history or present condition of allergic response to any cosmetic products (eye/ facial cosmetic products).
Volunteer Having eye infection or allergy.
Volunteer Having extremely sensitive eye condition.
Volunteer Having any form cutaneous disease which may influence the study result.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| T0(Prior product application ), T+30 minutes (post Product application ), T+1 day (Post product application ), T+2 days (Post product application, T+3 days (Post product application, T+4 days (Post product application), T+7 days (Prior product application & post product application ), T+10 days (Prior product application & post product application ), T+13 days (Prior product application & post product application ) |
t0 t1 t2 t8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="39" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/08/2016 |
| Date of Study Completion (India) |
16/08/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="14" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Brief Summary
The objective of this study will be to evaluate
the in-vivo safety & efficacy of Skin care formulation on
healthy female subjects of varied eye conditions (Normal Condition, Sensitive
Condition & Contact Lens Users) and varied skin conditions (Normal, Oily,
Dry & Combination) in terms of makeup removal formulation Objective: To evaluate the Ophthalmologic and
Dermal safety of the test products in causing no ocular irritation or dermal
irritation on repeated use involving subjects of varied eye conditions such as
normal condition, sensitive condition and contact lens users.
To evaluate the post use skin sensorial
and product efficacy in removing color cosmetics.
Duration of study: 14 days study
Kinetics:
T0(Prior product application ), T+30 minutes (post Product
application ), T+1 day (Post product application ), T+2 days
(Post product application, T+3 days (Post product application, T+4
days (Post product application), T+7 days (Prior product application
& post product application ), T+10 days (Prior product application & post product
application ), T+13 days (Prior product application & post product
application ).
· Population 40 Female subject . Subjects
with the specified eye condition as per the study requirement: normal condition, sensitive condition and
contact lens users in nearly equal ratio (13:13:14) & Subjects with the
specified skin type: normal, dry, oily and combination in nearly equal ratio
(1:1:1:1) .
Products
: Bi-phasic Make-up Remover.
|