1. [IPO0663] Study of the effects of cosmetic products to improve the condition of dry skin B.Tyszczuk 1, C. Vincent 1,R. Debowska 1, A. Kaszuba 2, A. Kaszuba 2, I. Eris 1 1 Dr. Irena Eris Cosmetic Laboratories, Dr. Irena Eris Centre for Science and Research, Warsaw, Poland 2 Specialist Medical Offices Dermed, Lodz, Poland Introduction Dry skin is nowadays a very common problem that may affect negatively the quality of life. It is perceived both as a skin care problem, as well as one of the clinical elements in several dermatoses. The aim of this study was to evaluate the safety and efficacy of a dry skin care program. Materials and Methods The study was performed in three phases: Phase I: in vitro skin irritation test EpiDerm TM, patch tests in patients with allergy and assessment by a Safety Assessor. EpiDerm TM was conducted according to the Standard Operation Protocol ECVAM (in vitro Skin Irritation Test: Human Skin Model, EpiDerm-200, Version: 7.0, 30 th Oct 2007). Shower gel assessment was conducted according to version: 5.0, Oct 2004. Phase II: pre-clinical evaluation of tested cosmetic products (by 20 volunteers each) including objective analysis (skin condition parameters evaluation- using equipment from Courage+Khazaka electronic GmbH) as well as self-evaluation questionnaire. Phase III: clinical trial in two groups of 50 patients who used the same face care program (day and night creams) and different body care programs (group A - shower gel and body lotion, group B - shower gel and body butter) for a period of 4 weeks. Dryness and scaling of the skin was evaluated according to the 1 to 10 scale, where (1-2) - means slight increase in symptom, (3-5) - average increase in symptom, (6-8) - strong increase in symptom and (9-10) - very strong increase in symptom. To assess the severity of itching a 10- point visual analogue scale was used. Skin condition was assessed both by dermatologists and patients according to questionnaires. Safety assessment results (Phase I) The in vitro skin irritation test results showed no irritation potential- cells viability was above 80% for each tested product. According to protocol cells viability should be higher than 50% to assess, that product as non irritating. Patch tests were conducted for each product on 30 patients with allergies. Results of dermatological assessments confirmed safety of tested products. Safety Assessor assessment confirmed that none of tested formulations shows any foreseeable risk to human health under conditions of normal use.

2. [IPO0663] Study of the effects of cosmetic products to improve the condition of dry skin Figure 2. Changes in sebum content after one use of the product. Results of pre-clinical evaluation (Phase II) Figure 1. Changes in skin moisturization after one use of the product. Figure 3. Changes in transepidermal water loss after 2 weeks of treatment with day and night creme. Preclinical test results showed significant improvement in skin condition (figure 1-2). Afer one use of products both moisturization and sebum content were maintaeined up to 4 hours at a high level. Face care creams reduced transepidermal water loss (TEWL) as well. Results obtained after 2 weeks of treatment showed, that the night cream had greater impact on the decrease in TEWL (-38%), than the day cream (-24%) (figure 3).

3. [IPO0663] Study of the effects of cosmetic products to improve the condition of dry skin Figure 5. Volunteers self-evaluation of a decrease in skin itching. Results of clinical trial (Phase III) Figure 4. Dermatologists evaluation of products for dry skin. Group A- day and night face creams, shower gel and body lotion. Group B- day ang night face creams, shower gel and body butter. group Agroup B decrease in skin dryness (face): -51% (for 98% of volunteers) -57% (for 98% of volunteers) decrease in skin dryness (body): -49% (for 100% of volunteers) -54% (for 100% of volunteers) decrease in scaling (face): -65% (for 80% of volunteers) -67% (for 62% of volunteers) decrease in scaling (body): - 50% (for 88% of volunteers) -60% (for 90% of volunteers) Clinical trial results evaluated by dermatologists showed reduction in skin dryness, itching and scaling (figure 4). Self- evaluation of volunteers in both preclinical and clinical trials also confirmed very good influence of evaluated products on their dry skin. Especially good results were observed for skin itching decrease (figure 5). Conclusions The tested program for dry skin contains emollients, which are crucial for proper dry skin care and could be a very good suplement of pharmacology treatments. Obtained results showed a significant impact of tested products on the dry skin condition (decrease in main symptoms of dry skin e.g. scaling, itching), which was evaluated objectively and subjectively. Moreover such a treatment affects positively the quality of life of people with the dry skin. This improvement was achieved by overcoming previous dryness, scaling and itching of the skin.