Face and periorbital region

Transcription

1 ANTI WRINKLE EFFICIENCY TESTS OBJECTIVE The aim of this study was to assess the anti-wrinkle efficacy of a cosmetic product before and after a period of product application compared to an untreated area. The long-term effects were investigated over a period of 8 weeks. The measurements were performed in the periorbital regions of female volunteers by investigating the three-dimensional structure of the wrinkles (DermaTOP), skin hydration (Corneometer), skin elasticity (Cutometer) and erythema (Chromameter) on the bones of the cheeks. Additionally, standardized images were taken and evaluated by 6 selected and trained raters at the end of the study for reduction of visible wrinkles as well as skin color uniformity and pigmentation (by means of ranking of macrophotos). MATERIALS AND METHODS TEST MATERIALS The test products were used as supplied by the Sponsor. Code A B Product/Code/Sponsor Untreated (negative control) Test products: Refining lotion (sequence 1) P-effect essence (sequence 2) Basing emulsion (sequence 3) DATE SAMPLES RECEIVED January 04, 2012 and February 07, 2012 STORAGE CONDITIONS APPLICATION AREA APPLICATION VOLUME Room temperature Face and periorbital region Determination by weighing the test products before and after the use period (see Appendix H)

2 APPLICATION MODE The test materials were applied by the subjects at home, twice daily, according to the following instruction ml of the lotion was mixed with 3-4 drops of serum directly in the palm of the hand and applied all over the face, including the periorbital region. After absorption of this mixture into the skin a fingertip (no more than 1 ml) of the crème was applied to the skin. SUBJECTS Subjects Enrolled 33 Complete data Exclusions None Age 45.2 ± 3.9 years (mean ±standard deviation) Sex All female INSTRUMENTAL MEASUREMENT (S) Skin capacitance (Corneometer CM 825, Courage&Khazaka, Köln) 5 repetitive measurements without minimum and maximum Skin Surface Profile Skin elasticity Erythema value Photography Parameters Ra and Rz, (DermaTOP blue, Eotech GmbH, France) 1 measurement Parameters Uf (R0: total elasticity), Ur/Uf (R7; elastic relaxation to total elasticity) 1 measurement (Chromameter CR 300, Minolta, Langenhagen) 3 repetitive measurements (Unit for Standardized and Reproducible Clinical Photography (USR- CliP) with Hasselblad camera H3D11-31 with High resolution 31 Megapixels. Standard illumination/lightning: General purpose white light. 1 image per side per subject PROTOCOL VIOLATIONS/ADDITIONAL REMARKS On study day 29 (February 02, 2012) relative humidity in the climatized room was about 40%, i.e. slightly lower than demanded by the study protocol (45 to 55% r.h.). Data measured with the Corneometer on day 29 showed no conspicuity. Therefore, this protocol deviation was classified as minor; all data were included into statistical analysis.

3 RESULTS: ERYTHEMA: Redness of the skin erythema was quantified by the measurement with a Chromameter. Redness is defined by a positive Chromameter a*-value correlates well with the visual assessments of erythema. An increase of the Chromameter a*- value corresponds to the degree of skin redness. Chromameter (a*): Mean Values and Results of the comparison of Measurement Times by Paired t-tests (n=33) Chromameter (a*)-difference to Baseline- Mean Values and 95% Cl Significantly lower Chromameter a*-values were measured on days 15 and 57 in comparison to baseline (day 1) for both treatments. Additionally, Chromameter (a*) values were significantly lower on days 57 in comparison to day 29 on the area treated with test product B. Value of skin erythema was reduced up to 35% after product application in comparison to untreated area.

4 SKIN CAPACITANCE Measurement of hydration of the upper skin layer (stratum corneum) was performed by the electrical capacitance method with a Corneometer. An increase of Corneometer values shows a skin moisturizing effect. Capacitance: Mean Values for Raw Data and Difference to base line (n=33) On the area treated with test product B, skin hydration continuously increased throughout the course of the study, while skin capacitance measured on the untreated area (A) remained about the same until the end of the study. The repeated measurement ANOVA of within subject factors treatment, time and their interactions detected significant differences between treatments (p<0.001). Capacitance: Mean Values of Difference to Day 1 and results for the Comparison of treatments by Paired t-tests (n=33) Capacitance- Difference to Baseline- Mean Values and 95% Cl After treatment with test product B, skin capacitance was significantly higher during all measurement times than on the treated skin (A) for difference to base line values.

5 Capacitance: Mean Values and Results of the Comparisons of Measurement Times by paired t- Tests (n=33) After treatment with test product B, significantly higher skin Capacitance values were measured on day 57 in comparison to day 1 (baseline), day 15 and day 29. Skin hydration increased throughout the study up to 96 % in comparison to control group and reached its maximum on day 57. SKIN SURFACE PROFILE Skin topography was measured by capturing the three dimentional surface structure of the investigated skin with CCD camera, using interference fringe profilometry (DermaTOP) (fig 1). From the captured three dimentional structure, roughness parameters Ra and Rz were calculated, representing the finer skin structure Ra and the rough structure Rz, such as wrinkles Rz. A decrease in the roughness parameters Ra and Rz corresponds to a decrease in the degree of skin roughness. Fig 1

6 Roughness (Ra): Mean Values of Difference to Day 1 and Results for the Comparisons of Treatments by Paired t-tests (n=33) Roughness (Ra)-Difference to Base Line-Mean Values and 95% Cl After 15 days of treatment with test product B, roughness of the finer skin structure Ra was significantly decreased and then remained on comparable level throughout the course of the study. On the untreated area (A), roughness Ra remained comparable throughout the course of the study. Roughness (Rz) Mean Values of Difference to Day 1 and Results for the Comparison of Treatments by Paired t-tests (n=33)

7 Roughness (Rz)-Mean Values- Difference to Baseline-95% Cl In comparison to day 1 (baseline), roughness of the rougher skin structure Rz on day 15 was minimally lower on the area treated with test product B, while it was higher on the untreated area (A). Throughout the rest of the study, roughness Rz remained on a comparable level on both test areas. Wrinkles were significantly reduced on day 15 after product application and remained on comparable level throughout the study. After 57 days of daily application the depth of wrinkles reduced up to 40 % in comparison to day 1. SKIN ELASTICITY Skin firmness was measured with a Cutometer. The measuring principle is based on a suction method. Using an optical measuring system, it was detected contactlessly how far the skin is sucked into the measuring head; this value gives a measure for skin elasticity. From the resulting measurement curves, parameters r0 (maximum extensibility of the skin, i.e. skin firmness) and r7 (relative elastic recovery, i.e. ability of the skin to return to its initial position after deformation) were calculated to characterize the skin elasticity. An increase of the parameter r0 corresponds to an increase of the degree of skin suppleness, and an increase of the parameter r7 corresponds to an increase of the degree of skin elasticity. Skin Elasticity Elasticity: Relative Elastic Recovery (r7) Elasticity (r7): Mean Values for Raw Data and Differences to Baseline (n = 33) The repeated measurement ANOVA of within subject factors treatment, time and their interactions detected significant difference between treatments (p=0.006)

8 Elasticity (r7): Mean Values of Difference to Day 1 and Results for the Comparison of Treatments by Paired t-tests (n=33) Cutometer (r7) Difference to Base line-mean Values and 95 %Cl On days 15 and 57, the increase of relative elastic recovery of the skin (r7) in comparison to baseline (day 1) was significantly higher on the area treated with test product B than on the untreated area (A) Skin elasticity showed an improvement after product application up to 55% on day 57.

9 Before Treatment After Treatment Fig 2. Photos of a subject before and after treatment Upper: color uniformity enhanced after product application Lower: wrinkles were smoothed out and plumped after product application CONCLUSION: Summarizing the results of the study, a statistically significant moisturizing effect of the product range (lotion, serum, crème) was measured: After 2, 4 and 8 weeks treatment with the product range, the skin was significantly more hydrated than untreated skin. Measurement of skin roughness showed a significantly finer skin structure (Ra) after 2 weeks treatment with the product range than on untreated skin. Additionally, an improvement of skin elasticity (r7) was measured after treatment with the product range in comparison to the untreated skin which was significant after 2 and 8 weeks treatment with the product range.