615 CENTELLA ASIATICA EXTRACTS IN SKIN REPAIR PRODUCTS Experimental de Evaluación Cutánea (Barcelona, Spain) (registry CI-S22/08). The study involved subjects of either gender and between 18 and 70 yr of age with a Fitzpatrick I–V skin phototype and reactive skin. The study excluded individuals with skin alterations on the forearm or skin characteristics capable of interfering with evaluation of the product, such as scars, pigmentation disorders, abundant body hair, and allergy or intolerance of topically administered products of the same class as the tested product. The three study variables were evaluated on both forearms (one treated arm and one control arm). An occlusive patch was applied with 45 µL of a 2% solution of sodium lauryl sulfate during 24 h (day 1, D1), followed by the application of Blastoactiva™ twice a day in the same zone. Evaluation of the three parameters (anti-irritant effect, skin barrier repair, and epidermal cell renewal) was made after 24 h, 48 h (D2 and D3, respectively) and over 14 d, as follows: • Anti-irritant action was assessed by colorimetry (Mexameter® MX 18, Courage & Khazaka Electronic, Köln, Germany) based on the amount of light absorbed by the skin and the clinical inspection of erythema intensity (from 0 = absent to 4 = severe). • Skin barrier function repair activity was quantified based on transepidermal water loss (Tewameter TM 300®, Courage & Khazaka Electronic) during 4 min, expressed as evaporated water in g/m2/h. • The effect upon epidermal cell renewal was assessed from the changes in skin color based on the individual typological angle (Cromameter CR, Minolta), where the faster the increase, the faster the cell renewal rate. In this test, 160 µL of the product was applied on a semiocclusive patch with 6% dihydroxyacetone, with analysis of the variations from D3 to D14. • In addition, the cosmetic qualities of the product were evaluated using a 23-item questionnaire in which most of the questions were scored based on a 5-point Likert scale (Figure 1). Testing showed Blastoactiva™ to exert a statistically significant anti-irritant effect (p 0.031), reducing erythema intensity after four applications, as well as a statistically significant barrier function repair effect (p 0.001), reducing transepidermal water loss by 24 and 29% after two and four applications, respectively. Likewise, a statistically significant effect (p 0.014) was observed in terms of epidermal cell renewal with acceleration of this process in 61% of the participants. The cosmetic properties of the product were favorably rated by 83 to 100% of the participants (Tables I and II). The dermatologist interpreted product acceptability as being very satisfactory (30–32), since none of the subjects presented clinical signs or discomfort attributable to the tested product. Study in a pediatric population. A group of 22 children (eight boys and fourteen girls) between 3 and 47 mo of age (with a mean age of 30 mo and range of 5–45) with Fitzpatrick I–V skin phototype and reactive skin were selected for the evaluation of skin and eye tolerability and of the cosmetic qualities and efficacy of Blastoactiva™. The children served as their own control. The parents signed the informed consent document, and the study was approved by the evaluation committee of Eurofins Product Testing, Cosmetics & Personal Care Spain, S.L.U. (Barcelona, Spain) (registry CI-S2/19). 1.5 g of the product was applied on a single side of the groin (zone of the fold) and on the entire waist (at diaper level) twice a day (morning and night) for 28 ± 2 consecutive d (4 weeks). The product could also be applied on any other localized zone presenting irritation during the study. One parent per child (the observing parent) assessed acceptability on a daily

616 JOURNAL OF COSMETIC SCIENCE basis and completed a questionnaire with eight items addressing the cosmetic qualities of the product, and five items referring to its cosmetic efficacy. Likewise, skin tolerability was analyzed by a dermatologist and a pediatrician through visual inspection of the study zone. An ophthalmologist evaluated ocular acceptability by examining the ocular mucosa and periocular zone before and after 4 weeks of use. The results of the cosmetic and efficacy evaluations are detailed in Table III and Figures 2–4. Between 86.4 and 100% of the observing parents agreed with all the aspects referred to the cosmetic qualities of the product. On the other hand, the rating of efficacy was very satisfactory with agreement expressed by 88.9 to 100% of the observing parents. ANSWERS POSSIBLE QUESTIONS 1. I am concerned about scars of superficial wounds, irritations, and aggression of the skin. 2. I am concerned about post-peeling, post-depilation, and solar aggressions. 3. I have tried some type of treatment to help repair or strengthen my skin (soothing irritation, favoring skin regeneration, etc.). - Too much - Much - Neither much nor little - Little - None 4. If affirmative, I applied the treatment... - I bought the product but did not use it - 1 wk - 2 wk - 1 mo - More than 1 mo 5. The product has generally improved the appearance of my skin. 6. The product has a pleasant texture. 7. The product leaves my skin feeling soft and smooth. 8. The product hydrates my skin. 9. I consider that the product strengthens my skin. 10. The product has a pleasant smell. 11. The product is quickly absorbed. 12. The product leaves no residue on the skin. 13. The product is not oily. 14. The product does not stain clothing. 15. In general, I am satisfied with the product. 16. Would you recommend this product to your friends? - Very much agree - Agree - Neither agree nor disagree - Disagree - Very much disagree 17. How much would you pay for the tested product? - Less than 10€ - Between 10–15€ - Less than 20€ - Between 20–25€ 18. Considering the previous answer, would you buy the product if it cost 15€? - Yes, certainly - Probably - I don't know - No - Never 19. How often would you apply this product? - 3 times a week - Once a day in the morning - Once a day at night - Twice a day - Three times a day 20. Do you consider it adequate to have two presentations (50 and 150 mL) of the product according to its point / extensive use? 21. Do you consider this to be a unisex product? 22. Would you use it again? - Yes - No 23. Product format, 50 mand 150 mL we would like to know which format you would use in each case. - Post-healing - Irritation - Skin aggression - Sunburn - Post-peeling - Post-depilation - After shaving - Post-laser surgery - Tattoos Figure 1. Questionnaire used in the efficacy and acceptability study of Blastoactiva™ in healthy volunteers.