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Product Efficacy

Product Efficacy

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Product Efficacy

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  1. Product Efficacy Raman Govindarajan, M.D., PhD Regional Director Medical & Scientific Affairs Johnson & Johnson Asia Pacific

  2. Outline • Why measure product efficacy • How to measure product efficacy • In vitro studies • In vivo studies • Animal studies • Human studies • Conclusions and claims

  3. Why Measure Product Efficacy • Consumer care products are meant to provide users with some defined benefits. • Claims are made based on products being able to deliver on these claims • Manufacturers are responsible for having data on file to support the claims being made • The data should withstand scrutiny by independent experts in case of challenge

  4. Measuring product efficacy • Products have effects because of ingredients contained in them! • Each ingredient in a product has a function • See hand out • A judicious combination of ingredients can give unique benefits and thus unique claims • Claims are based on activity of ingredients or of the entire formulation

  5. Measuring product efficacy • Ingredient claims • History of use for particular benefit • In vitro data – lab data/ data from cells • Clinical data • Same formulation • Similar formulation • Different formulation/ product form

  6. Measuring product efficacy • Formulation claim • Surrogate/ representative clinical data • Abbreviated clinical data • Full Clinical data • Same formulation • Similar formulation • Different formulation • Consumer data

  7. Measuring product efficacy • Expert assessment • Instrumental assessment • Self assessment • Correlations – relevance to consumer benefit and claims • Statistical considerations

  8. Clinical essentials • Safety clearance • Ethical clearance • Protocol and procedures • How often, how much, how many subjects • How to measure – reproducibility & sensitivity • Data recording/ storage • Data analysis and conclusions

  9. Measuring product efficacy-clinical end points • Skin • Hair • Oral • Deodorants • Color cosmetics • Intimate Hygiene

  10. Skin Lightening Aging Pimples/Acne/Oil control Redness/ Sensitive skin Scars/ blemishes Moisturization Hair Conditioning/ cleaning Growth promotion Growth retardation Dandruff control Styling/ Coloring Damage control/ repair Skin & Hair

  11. Oral Plaque/ Gingivitis Caries Malodor Whitening Mucous membrane Intimate Hygiene Wetness control Odor control Deodorants Perspiration control Mopping/ reduction Malodor control Perfume Color Cosmetics Color fastness/long lasting moisturizing Oral,Deodorants,Color cosmetics & Intimate Hygiene

  12. Expert Grading Assessment of efficacy using a n-point scale where 0 is equivalent to the perfect condition and (n-1) indicates the worst/most severe condition of a skin attribute e.g. Fine lines & wrinkles

  13. Improvement of Elasticity Method: Instrumental measurement of the mechanical properties of the skin Cutometer® SEM 575 Elasticity as a function of age

  14. Reduction in fine lines and wrinkles Method: High resolution digital imaging Before After lines are less deep

  15. Reduction in laxity/sagging Method: 3D imaging using stripe projection to create topography map of skin surface Red = lifted Blue = slimmed Cross-section Green = unchanged Green = before Red = after

  16. Expert Grading Moisturization and Skin condition • Overall Dry Skin Score • Overall Smoothness • Overall Laxity • Lines and Wrinkles – fine and deep • Age spots • Freckles

  17. Instrumental Measurements Moisturization • Surface moisture • Trans-epidermal water loss • Dryness/Scaling

  18. Increase in Skin Moisture Method: Instrumental measurement of skin conductance Skicon® 200 Moisturization Profile

  19. Decrease in TEWL Method: Instrumental measurement of trans-epidermal water loss Tewameter® TM 210 TEWL Profile

  20. Reduction in scaliness Method: High-resolution imaging with skin surface profiling (Visioscan® VC 98) Baseline (Atopic skin) After 4 Weeks

  21. Removal of dead skin cells Method: Detection of corneocytes adhered on tape after stripping

  22. Improvement in skin smoothness Method: High-resolution imaging with skin surface profiling (Visioscan® VC 98) Before washing – deep lines, with scales After washing – lines become less deep, skin is more plump

  23. Reduction in width/depth Method: 3D imaging using stripe projection to create topography map of skin surface Baseline 10 minutes after washing Cross-section of pore

  24. Reduction in enlargedpore count Method: Parallel-polarized imaging to enhance surface features

  25. Expert Grading Acne • Global Assessment of Overall Severity • Lesion Count (papules, pustules, open/closed comedones) • Target Lesion Assessment of Erythema, Scaling and Size/Elevation • Overall oilyness • Pore and plug counts/ degree of block

  26. Instrumental Measurements Acne • Target lesion redness, inflammation and size/elevation • Lesion count • Scar volume and redness

  27. Target Lesion: Reduction in redness Method: Absorbance measurement of oxy-hemoglobin via diffuse reflectance spectroscopy (DRS) DRS Schematic Diagram Absorbance profiles of skin chromophores

  28. Target Lesion: Reduction in inflammation Method: Fluorescence intensity measurement of inflammation markers excited at 280 nm Skinskan Schematic Diagram 14-Day Irritation Profile of an Acne Lesion

  29. Target Lesion: Reduction in size or elevation Method: 3D imaging using stripe projection to create topography map of skin surface Height Baseline = 0.513 mm Height Day 7 = 0.323 mm

  30. Global: Reduction in lesion count Method: High resolution digital imaging • Visible light for detection of lesions • Blue fluorescence for horn & porphyrin Visible Blue Fluorescence

  31. Acne Scars: Reduction in size/volume Method: High-resolution imaging with skin surface profiling (Visioscan VC 98) 26% reduction in volume after 12 weeks

  32. Reduction in sebum Method: Detection of surface lipids using Sebumeter® SM 810 or Sebufix® F16 Before Washing 8 Hrs After Washing

  33. Removal of plugs inside pores Method: Detection of horn via blue fluorescence imaging Baseline 4 Weeks of Scrub Use

  34. Expert Grading Skin Lightening • Overall Fairness • Overall Evenness • Spot Lightness • Sallowness

  35. Instrumental Measurements Skin Lightening • Visual improvement • Skin color • Tone Evenness • Spots

  36. Visual Improvement Method: Pixel luminosity determination of high resolution digital images Baseline Luminosity = 136 Week 4 Luminosity = 144

  37. Improvement in overall skin color Method: Instrumental measurement of L* (lightness), a* (redness) and b* (yellowness) values Chromameter® CR-300 L*a*b* Color space

  38. Improvement in skin tone evenness Method: Pixel luminosity variance determination of high resolution digital images

  39. Improvement in dark spot color Method: Pixel luminosity determination of high resolution digital images Baseline 8 Weeks

  40. Instrumental Measurements • Deposition of actives • Percutaneous absorption of actives • Localization in area of interest • Franz cell • Tape stripping and chemical analysis/ imaging

  41. Salicylic Acid Deposition Method: UV Fluorescence Imaging Before Use After Use

  42. Titanium Dioxide Deposition Method: UV Fluorescence Imaging Before Use After Use

  43. Rinsability Method: Residue detection via FTIR and UV fluorescence FTIR spectra Before rinsing After rinsing

  44. Instrumental Measurements Need to complement/supplement expert grading with the use of objective and non-invasive methods of evaluation to gain a more thorough understanding of skin structure and function.

  45. Hair evaluation • Efficacy of conditioners – total combing time • Count loss of hair • Shine on hair by image analysis – using parallel polarized photography • Microscopy to detect damage to hair • Color of hair by L a b measurements • Penetration of actives into hair root – by tagged actives • Strength of hair by “Instron” stretching

  46. Oral evaluation • Intra oral photography • Plaque area assessment – disclosing tablets. • Staining of teeth/whitening – L a b measurements • Ulcer/ bleeding area documentation • Gingivititis assessment – probing (by qualified dentist) degree of bleeding and no. of bleeding points • Scoring for severity of caries (DTMF score) • Sensitive teeth – subject assessment of relief • Malodor – volatile sulfur compound detection (GC)

  47. Malodor evaluation • Sampling of body odor – feeding odor to GC directly, expert assessment • Malodor profile • Differences between male and female • Malodor quenching by perfumes • Antibacterial tests – in vitro and in vivo