MedPath

safety & efficacy of skin care formulatio

Not Applicable
Completed
Registration Number
CTRI/2018/02/012199
Lead Sponsor
ITC LIMITED ITC Life Sciences and Technology Centre
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
39
Inclusion Criteria

Skin is healthy (free of eczema, wounds, inflammatory scarâ?¦.)

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 â?? 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.

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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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