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AHCare Efficacy Verification

AHCare Efficacy Verification. Proof of Principle. AHCare complexes compared to AHA formulations are: less irritating less stinging at minimum of equivalent efficacy Glycolic/Lactic acid complexed with arginine additional work is ongoing with other complexes. Proof of Principle Studies.

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AHCare Efficacy Verification

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  1. AHCare Efficacy Verification

  2. Proof of Principle • AHCare complexes compared to AHA formulations are: • less irritating • less stinging • at minimum of equivalent efficacy • Glycolic/Lactic acid complexed with arginine • additional work is ongoing with other complexes

  3. Proof of Principle Studies • Objective: Compare AHCare complexes to AHAs partially neutralized with conventional agents to determine irritation profiles. • Method: 14 Day Cumulative Irritation Test on Humans (n=24); 14 consecutive days including weekends with occlusive patches. (Hill Top Research) • Comparison of test materials to 0.9% NaCl (negative control) and 0.1% SLS (positive control)

  4. Proof of Principle Studies • Test materials:Aqueous solutions of glycolic acid partially neutralized to pH 3.5 using (1) arginine (amphoteric), (2) NaOH (alkali), (3) Ammonium Hydroxide • Conclusion: solution partially neutralized with arginine is more mild than the glycolic acid solutions partially neutralized with either sodium hydroxide or ammonium hydroxide

  5. Cumulative Irritation Study20% Glycolic Acid, pH 3.5 Statistical Differences, p<0.05: NH4OH vs. Arginine: days 2-11 and overall NaOH vs. Arginine: days 2-6, 8-10 and overall

  6. Cumulative Irritation Study 20% Glycolic Acid Solutions, pH 3.5 4 days to moderate irritation vs. 11 days n=24 Days of Patching Statistical Differences, p<0.05. NH4OH vs. Arginine: days 2-11 and overall

  7. Proof of Principle Studies • Objective: Compare Amphoteric AHA complexes (AHCare) to AHAs partially neutralized with conventional agents to determine the stinging profile. • Method: Method: Lactic Acid Sting Test; n=20 female ‘stingers’; (CPTC) • Application to nasolabial fold and cheek area • Screened panelists using 10% unneutralized lactic acid

  8. Proof of Principle Studies • Test materials: Comparison of lactic acid (20%, aq.) partially neutralized to pH 3.5 using (1) arginine (amphoteric), (2) NaOH (alkali), (3) Ammonium Hydroxide • Negative control - water • Conclusion: Solutions containing arginine induced significantly less stinging than those containing sodium hydroxide and ammonium hydroxide • Arginine containing solutions were equivalent to the negative control solution (water)

  9. Facial Sting Study20% Lactic Acid Partially Neutralized to pH=3.5 * * * n=21 *Statistical Significance p<0.05

  10. Facial Sting Study20% Lactic Acid Partially Neutralized to pH=3.5 n=21 No significant differences

  11. Facial Sting StudyAHCare (Arginine) 10% Glycolic Acid Adjusted to pH=3.5 Sting Sensation Averages

  12. Proof of Principle Studies • Objective: Compare the efficaciousness of Amphoteric AHA (AHCare) complexes to AHAs neutralized using conventional, non-amphoteric agents • Method: Dansyl Chloride Cell Turnover; product application twice daily

  13. Dansyl ChlorideStudy # 2, n=5 Solutions = 10% Glycolic Acid, pH 3.5

  14. Dansyl Chloride Study 3, n=6Cream = 10% Glycolic Acid, pH 3.5

  15. Dansyl Chloride Study 4a, n=5 Solutions = 10% Lactic Acid, pH 3.5

  16. AHCare L 65Cell Turnover Study - CPT Dansyl Chloride Cell Turnover Study 10% 10% AHCare™ L 65 AHCare equivalent to Lactic Acid AHCare, Lactic Acid outperform placebo, p<0.05

  17. Proof of Principle Studies • Objective: Determine the regenerating and revitalizing activities on human fibroblasts cultured in vitro of AHCare G-60. • Method: Human dermal fibroblasts were incubated in a standard medium of cell culture with fetal calf serum. After an incubation for 3 days, the medium was exchanged for a standard medium with or without FCS but with AHCare G-60 and re-incubated for 3 days.

  18. Cellular Protein GrowthAHCare G-60 Cellular Proteins % AHCare G-60

  19. Summary • Glycolic acid amphoteric complexes: • prototypes showed comparable efficacy to NH4OH (non-amphoteric) prototypes • creams showed comparable efficacy to marketed non-amphoteric cream • Lactic acid formulations • amphoteric complex prototypes showed comparable efficacy to NH4OH (non-amphoteric) prototypes

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