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safety & efficacy of skin care formulation

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. - not applicable

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/02/012199
Enrollment
40
Registered
2018-02-28
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: 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

Sponsors

ITC LIMITED ITC Life Sciences and Technology Centre
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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 )Timepoint: t0 t1 t2 t8

Secondary

MeasureTime frame
not applicableTimepoint: not applicable

Countries

India

Contacts

Public ContactMr Mohit Lalvani

MASCOT-SPINCONTROL India Pvt. Ltd.

janaki@mascotspincontrol.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026