SAFE? ALL YOU NEED ONE LAB

Transcription

1 Safety tests 1

2 Is your product SAFE? 2

3 Client orientation - Mainly In- vivo Tests - Clinical control - Volunteers: volunteers database - Caucasian, negroid, asian - Several skin types - Fast recruitment Scientific excellence Ethics Commitment

4 Acute cutaneous irritation test (patch test) - Study goal: to assess the skin compatibility of cosmetic products through a single test application under occlusion or semi-occlusion (patch test). - Volunteers: at least 10 volunteers - Product application: single application with occlusive or semi-occlusive patchs calculation of the acute irritation index (M.I.I.) M.I.I. M.I.I CLASS Non irritating 0.20 < M.I.I Slightly irritating 0.50 < M.I.I. 1 Moderately irritating M.I.I. > 1 Irritating - Time-Points of evaluation: 30 min. and 24 h after patch removal 4

5 Cumulative Irritation & Sensitization test (HRIPT) - Study goal: to confirm the skin compatibility and the absence of allergenic potential of a cosmetic product after repeated applications under occlusion. - Volunteers: at least 50 volunteers - Product application: 9 consecutive patch test (induction phase) + 1 challenge test (challenge phase) Evaluation of the skin compatibility and cumulative irritation of the product: classification of the product as having very good, good, moderate or bad skin compatibility at the end of the induction phase Analysis of the allergenic potential of the product: based on the ICDRG (International Contact Dermatitis Research Group) allergenicity evaluation scale 5

6 Compatibility test (open test) under dermatologic control - Study goal: to assess the skin compatibility after repeated applications without occlusion and under dermatologic control - Volunteers: at least 20 volunteers - Product application: 5 daily applications at research centre in the hemiface or in the fold of the elbow Evaluation of the skin compatibility and cumulative irritation of the product: classification of the product as having very good, good, moderate or bad skin compatibility - Time-Points of evaluation: 45 minutes after each application 6

7 Ocular Irritation test (HET-CAM) - Study goal: to evaluate the ocular irritation effect that may occur in the conjunctiva following exposure to the product - Procedure: HET-CAM test (Hen's Egg Test Chorioallantoic Membrane) Irritant effects in the CAM blood vessels and albumen are subjectively assessed and a score is assigned based on the time required for development of each endpoint: - Time-Points of evaluation: 0.5, 2, and 5 minutes after rinsing-off the test substance. 7

8 Tolerance test (use test) - Study goal: to evaluate the acceptability and skin tolerance of a cosmetic product - Volunteers: at least 20 volunteers - Product application: as expected to be used (e.g: twice daily for 28 days) Evaluation of the acceptability and skin tolerance by subjective self-assessment questionnaires - Time-Points of evaluation: after x days of product use (e.g: 28 days) 8

9 Tolerance test (use test) under dermatologic control - Study goal: to evaluate the acceptability and skin tolerance of a cosmetic product - Volunteers: at least 20 volunteers - Product application: as expected to be used (e.g: twice daily for 28 days) Clinical score of irritation signs and symptoms by the dermatologist Evaluation of the acceptability and skin tolerance by subjective self-assessment questionnaires - Time-Points of evaluation: after x days of product use (e.g: 28 days) 9

10 Tolerance test (use test) under gynecologic control - Study goal: to evaluate the acceptability and tolerance of a cosmetic product - Volunteers: at least 20 volunteers - Product application: as expected to be used (e.g: twice daily for 28 days) Clinical score of irritation signs and symptoms by the gynecologist Evaluation of the acceptability and tolerance by subjective self-assessment questionnaires - Time-Points of evaluation: after x days of product use (e.g: 28 days) 10

11 Periocular Tolerance test (use test) under ophthalmologic control - Study goal: to assess the irritation potential of a topical product applied on the eye contour area - Volunteers: at least 20 volunteers - Product application: as expected to be used (e.g: twice daily for 28 days) Evaluation of the acceptability and skin tolerance by subjective self-assessment questionnaires Evaluation of the condition of the eye and around the eye area by the ophthalmologist - Time-Points of evaluation: after x days of product use (e.g: 28 days) 11

12 Ophthalmologist controlled single ocular instillation study - Study goal: to determine if a tear-free claim can be substantiated for a product - Volunteers: at least 20 volunteers - Product application: a drop of diluted test product and reference product is instilled in the eyes (one in each eye) Evaluation of the burning, stinging or itching sensations by selfassessment questionnaires Evaluation by the ophthalmologist before and after product application, for signs of tearing, conjunctival irritation and scleral redness based on a scale - Time-Points of evaluation: 10 seconds, 15 minutes and 60 minutes after product application 12

13 Non-Acnegenicity & Non-Comedogenicity test under dermatologic control - Study goal: to evaluate if a cosmetic product is non-acnogenic and non-comedogenic, in volunteers presenting acne-prone skin and combination or oily skin - Volunteers: at least 20 volunteers - Product application: as expected to be used (e.g: twice daily for 28 days) comedones and acneic lesions count by the dermatologist skin sebum measurement with the equipment Sebumeter macrophotographies with the equipment Visioface acceptability and skin tolerance by self-assessment questionnaires - Time-Points of evaluation: after x days of product use (e.g: 28 days) 13

14 Stinging test - Study goal: to evaluate the stinging effect of topical products - Volunteers: at least 20 volunteers (lactic acid stingers) - Product application: product and placebo are rubbed over the nasolabial fold and cheek of the volunteers (one in each side of the face) stinging sensation scoring after product and placebo application - Time-Points of evaluation: after 10 s, 2.5 min, 5 min and 8 min of exposure 14

15 Stinging test in damaged skin - Study goal: to assess the stinging potential of cosmetic products on previously damaged skin by tape stripping - Volunteers: at least 20 volunteers - Product application: products and controls are applied in the respective damaged skin site with sterilized gauze and left for 5 minutes TEWL is measured before and after stripping to verify the level of skin damage induced by stripping The stinging sensation is evaluated during substance-skin contact time (5 minutes) using a five point intensity scale (0 Absent; 1 Slight; 2 Moderate; 3 High; 4 Very High) - Time-Points of evaluation: immediately after application, 15 sec, 30 sec, 1 minute, 2 minutes, 3 minutes, 4 minutes and 5 minutes after application as also as the respective time-point every time the volunteer feels a change in the score of stinging sensation 15

16 PROJECT MANAGEMENT Mod.003 Proposition Study Plan and Tecnhical Records Mod.034 Report

17 R&D, TESTING AND REGULATORY SERVICES TO THE PHARMACEUTICAL AND PERSONAL CARE INDUSTRIES