CTRI/2019/01/017002Completed未知
To evaluate in-vivo safety of test product retained on skin for varied durations on healthy human volunteers of varied skin type. - Not Applicable
ITC Life Sciences Technology Centre0 sites34 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 34
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Standard criteria
- •1) Indian Male & Female subjects.
- •2) 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)
- •3) Between 18 and 60 years of age.
- •4) Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scarââ?¬Â¦.)
- •Specific criteria
- •5) Subjects representing varied skin types (ideally equal representation of all 5 skin types ââ?¬â?? Oily, Normal, Dry, Combination & Sensitive skin
- •6) Subjects free of any obvious infection of skin as determined by Dermatologist
- •7) Subjects willing to give a written informed consent
- •8) Subjects willing to abide by the study requirements and visit the site for regular follow up
Exclusion Criteria
- •Standard criteria
- •1) For female: Female subjects who are pregnant (UPT basis), lactating or planning pregnancy during the course of the study (Subjects inputs).
- •2) Having refused to give her/his assent
- •3) Taking part in another study liable to interfere with this study
- •4) Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months)
- •5) Having a progressive asthma (either under treatment or last fit in the last 2 years)
- •6) Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
- •7) Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
- •8) Being epileptic.
- •9) 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 (Except Paracetamol)
- •10) Having cutaneous hypersensitivity.
- •11) Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •12) Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
- •13) Having changed her/his cosmetic habits except those required by the protocol in the 14 days preceding the start of the study on the studied anatomic unit.
- •14) Having any genetic and endocrinal disorders as disclosed by volunteers
- •15) Refusing to follow the study restrictions:
- •16) For female: Non participation in activities leading to pregnancy and breastfeeding
- •17) Non participation in another study liable to interfere with this study
- •18) Abstinence from medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (except Paracetamol).
- •19) During the study : Abstinence from use of any products other than the test product on treated site
- •20) The day of the measurements : Non usage of test product (only test site cleaned with water is accepted).
- •Standard criteria
- •1) For female: Female subjects who are pregnant (UPT basis), lactating or planning pregnancy during the course of the study (Subjects inputs).
- •2) Having refused to give her/his assent
- •3) Taking part in another study liable to interfere with this study
- •4) Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months)
- •5) Having a progressive asthma (either under treatment or last fit in the last 2 years)
- •6) Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
- •7) Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
- •8) Being epileptic.
- •9) 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 (Except Paracetamol)
- •10) Having cutaneous hypersensitivity.
- •11) Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •12) Having undergone a surgery requir
Investigators
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