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"Cosmetic Acceptability study(including skin and eye examination) of a skin foundation for four weeks, in 60 adult subjects

"CLINICAL EVALUATION OF THE CUTANEOUS, OCULAR AND COSMETIC ACCEPTABILITY OF A SKIN FOUNDATION APPLIED UNDER NORMAL CONDITIONS OF USE, FOR FOUR WEEKS, BY 60 ADULT SUBJECTS- USE TEST UNDER DERMATOLOGICAL AND OPHTHALMOLOGICAL CONTROL ".

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/04/001670
Enrollment
60
Registered
2011-04-07
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: Fond de teint: Skin Foundation, Once to twice daily, Topical application Control Intervention1: Not Applicable: NIL

Sponsors

LOREAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Sex: female. ? Age: 18 ? 45 years old. ? Subject with all type of skin on the face. ? Subject usually wearing fairness cream. ? Subject with sensitive skin (50% of the subjects) ?Subject with normal eyes (10 subjects only) ?Subject with sensitive eyes (20 subjects only) ? Subject wearing contact lenses (20 subjects only) ? Subject having given freely and expressly their informed consent, cooperative and aware of the necessity and duration of the controls so that perfect adhesion to the protocol can be expected. ? Subject who is able to read and understand documents transmitted (consent and information form). ? Subject having an official domicile. ? Subject accepting not to apply cosmetic products other than those she usually applies on and at their usual frequency of application. ? Subject having access to health services.

Exclusion criteria

Exclusion criteria: Subject who is pregnant or nursing or who is planning a pregnancy during the study, ? Current use of immunosuppressive drugs and/or an organ transplant, ? Current use of topical or systemic anti-inflammatory drugs for a defined medical condition, e.g. aspirin, ibuprofen, corticosteroids, ? Application within the last two months of any anti-inflammatory drug to skin area to be used in studying, ? Insulin-dependent diabetes, ? Currently receiving allergy injections, final injection within the last week, or expecting to begin injections during the course of the study, ? Immune deficiency or autoimmune disease, ? Skin disorders affecting the study area which, in the investigators? judgment, would interfere with grading / assessment of skin response (e.g. acne, psoriasis, disorders of pigmentation, scars, hyperhidrosis, etc, ?), ? Subjects with any skin disorder that could compromise evaluation of skin reactions, ? Subject having ocular pathology other than the one which involves allergy to some substance thereby causing sensitive eyes. ? Vaccination during the three weeks preceeding the study or intention to be vaccinated during the course of the study, ? A condition or medication which, in the investigator?s judgment, makes the subject ineligible or places the subject at undue risk, ? Current participation in another clinical study of any kind, ? Subject who is unwilling or unable to give informed consent or to otherwise comply with protocol requirements, ? Subject who cannot be contacted in case of emergency, ? Febrile disease in the three days preceding the study. ? Personnel of the investigating laboratory

Design outcomes

Primary

MeasureTime frame
cutaneous and ocular acceptabilityTimepoint: Day 0 and Day 28

Secondary

MeasureTime frame
SUBJECTIVE EVALUATION OF COSMETIC ACCEPTABILITY BY THE SUBJECTSTimepoint: DAY 7

Countries

India

Contacts

Public ContactRashi Nangia
smiglani@cidp-cro.com011-40793385

Outcome results

None listed

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