Cosmetic Acceptability study(including skin and eye examination) of a skin foundation for four weeks, in 60 adult subjects
- Registration Number
- CTRI/2011/04/001670
- Lead Sponsor
- OREA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method cutaneous and ocular acceptabilityTimepoint: Day 0 and Day 28
- Secondary Outcome Measures
Name Time Method SUBJECTIVE EVALUATION OF COSMETIC ACCEPTABILITY BY THE SUBJECTSTimepoint: DAY 7