safety & efficacy of skin care formulation

Completed

• Conditions: healthy

• Registration Number: CTRI/2018/02/012199
• Lead Sponsor: ITC LIMITED ITC Life Sciences and Technology Centre

Brief Summary

**Brief Summary**

The objective of this study will be to evaluatethe in-vivo safety & efficacy of Skin care formulation  onhealthy female subjects of varied eye conditions (Normal Condition, SensitiveCondition & Contact Lens Users) and varied skin conditions (Normal, Oily,Dry & Combination) in terms of makeup removal formulation

**Objective:** **To evaluate the Ophthalmologic andDermal safety of the test products in causing no ocular irritation or dermalirritation on repeated use involving subjects of varied eye conditions such asnormal condition, sensitive condition and contact lens users.**

**To evaluate the post use skin sensorialand product efficacy in removing color cosmetics.**

**Duration of study: 14 days study**

**Kinetics:T0**(Prior product application ), **T+30** minutes (post Productapplication ), **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 productapplication ), **T+13** days (Prior product application & post productapplication ).

·    **Population 40 Female subject . Subjectswith the specified eye condition as per the study requirement**: **normal condition, sensitive condition andcontact lens users in nearly equal ratio (13:13:14) & Subjects with thespecified skin type: normal, dry, oily and combination in nearly equal ratio(1:1:1:1)** .

**Products:** **Bi-phasic Make-up Remover.**

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-08-16
• Study Start: 2016-09-08
• Last Update Posted: 2018-02-23

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
not applicable	not applicable

Trial Locations

Locations (1)

MASCOT-SPINCONTROL India Pvt. Ltd.; 🇮🇳 Mumbai, MAHARASHTRA, India

MASCOT-SPINCONTROL India Pvt. Ltd.

🇮🇳Mumbai, MAHARASHTRA, India

Dr Janaki

Principal investigator

022-43349191

janaki@mascotspincontrol.in