CONTROLLED USAGE STUDY TO EVALUATE EFFICACY OF AN ANTI-AGING PRODUCT

OBJECTIVE
The purpose of this study is to evaluate the performance of an anti-aging eye cream product intended to increase skin firmness and reduce the appearance of fine lines, wrinkles and crows feet in the peri-orbital area when tested over a 28 and 56 day period. Wrinkle assessment was conducted instrumentally using a Visioscan image analysis system. Elasticity and viscoelastic properties of the skin were measured as a function of flexibility and firmness employing a Cutometer. In addition product effectiveness was subjectively evaluated using panelist self-assessment via questionnaire responses. SURFACE EVALUATION OF LIVING SKIN (SELS) VISIOSCAN The Visioscan (Courage and Khazaka) takes a direct image of the living skin using a measuring head containing a CCD-camera and two metal halogen lamps positioned opposite each other in order to ensure even illumination of the measuring field on the skin. The grey level distribution of the pixels in the image correspond to different phenomena (white pixels represent desquamation on the skin, dark pixels represent lines and wrinkles). The software with the Visioscan automatically calculates skin smoothness, skin roughness, scaliness and wrinkle parameters. Ref.1: Fischer, T.W., Wigger-Alberti W., Elsner P., Direct and non-direct measurement techniques for analysis of skin surface topography. Skin Pharmacol Appl Skin Physiol 1999; 12:1-11. Ref.2: Mike Farwick, Ursula Maczkiewitz, Peter Lersch, Tim Falla, Susanne Grether-Beck, Jean Krutmann; An EC-derived Tetrapeptide to Counterbalance ECM Degeneration; Cosmetic & Toiletries magazine, Vol124 Np. 6/June 2009 SKIN ELASTICITY CUTOMETER Cutometer SEM 575 (model 575 Courage + Khazaka) is used to measure skin viscoelastic properties. The measuring principle is based on a suction method. Negative pressure is created in the device, which can be regulated between 20 and 500mbar. Skin is drawn into a calibrated aperture of the probe by negative pressure where skin penetration depth is determined by a non-contact optical measuring system. The optical measuring system consists of a light transmitter and a light recipient, as well as two glass prisms facing each other, which project the light from transmitter to recipient. The light intensity will vary due to the penetration depth of the skin. Ref.1: Agache, P.G., Monneur, C., Leveque, J.L., and de Rigal, J. Mechanical properties and Youngs modulus of human skin in-vivo, Arch. Dermatol. Res., 269, 221, 1980. Ref.2: de Rigal, J. and Leveque, J.J., In vivo measurement of the stratum corneum elasticity, Bioeng. Skin, 1, 13, 1985.

SAMPLE DESCRIPTION

Test samples labeled Lifeline Eye Firming Complex, Formula: 12-330, Lot: C-509 were received from Lifeline Skin Care.

PANEL DEMOGRAPHICS
Number of subjects enrolled Number of subjects completing study Age Range Sex Race 25 25 45 - 57 Female Caucasian

PROCEDURE

As a condition of enrollment, only the subjects who were currently not using any anti-aging products, and who have abstained from using them for at least 7 days prior to study commencement were recruited for participation in this investigation. On the initial day of the study, upon arrival at the testing facility, subjects were required to familiarize themselves with and sign the informed consent. Subjects were mandated to adhere to all the restrictions mentioned in the inclusion/exclusion Sections (4.1 and 4.2). All participants were advised of the general nature and purpose of this study. The subjects then were acclimated to the ambient environment for a period of thirty minutes prior to baseline evaluation. Same acclimation procedure was applied to any following evaluation time point. Prior to baseline measurements being taken, areas of involvement were marked on the facial surface using a standard template, to ensure that instruments were repositioned in the same place at each visit. The biophysical measurements (Surface Evaluation of Living Skin via Visioscan and Skin Elasticity via Cutometer) were conducted by a trained technician. Panelists received verbal and written instructions regarding product use and study restrictions. Subjects were required to use the test product as a part of their daily routine according to the following sponsor supplied instructions: Cleanse face thoroughly morning and evening. Apply one pump of eye cream around each eye, and tap until fully absorbed. Apply SPF30 sunscreen before going outside and continue use of moisturizers per your normal skincare regimen. After 28 and 56 days of daily use of the test product, test subjects returned to the study site. After acclimating to ambient conditions, the measurements (Surface Evaluation of Living Skin via Visioscan and Skin Elasticity via Cutometer) were repeated using the standard template to identify sites on the face. In addition (during the acclimation period) all participants were asked to fill out a self-assessment questionnaire after 28 and 56 days of use. The following distinct noninvasive methods were employed to establish evaluation parameters:

ARCHIVING

All original samples, raw data sheets, technician's notebooks, correspondence files, copies of final reports and remaining specimens are maintained on the premises of AMA Laboratories, Inc. in limited access marked storage files. A duplicate DVD copy of final reports is separately archived in a bank safe deposit vault.

CONCLUSIONS

Within the limits imposed by the conduct and population size of the study described herein, the test material was reported by the majority of test panelists to be effective in reducing fine lines and wrinkles and improving the overall condition of the skin around eye area. Additional instrumental analysis performed for the test product demonstrated increases in skin biological elasticity on the site treated with the product. Demonstrated increases are considered statistically significant after 28 and 56 days of use. *Statistically Significant Surface evaluation of living skin via Visioscan demonstrated decreases in (SEr) parameter associated with the depth of fine lines and wrinkles. The reductions are considered statistically significant after 28 and 56 days of use.

LIFELINE SKIN CARE, INC.

760.692.4729 main | 760.476.0600 fax | www.lifelineskincare.com

Visioscan - Roughness Reduction (SEr)

3.30 3.10 2.90 2.70 2.50 2.30 2.10 1.90 1.70 1.50

Skin Elasticity via Cutometer (R7)

0.3600 0.3500

3.22 0.00% 2.72 -15.34% 2.40 -25.38%

0.3574 11.40%

0.3400

0.3300

0.3466 8.03% 0.3208 0.00%

0.3200

0.3100

0.3000

Baseline %Difference: Max% Improvement:

*Statistically Significant

Day 28 -15.34%* -43.59% Day 28

Day 56 -25.38%* -49.78%

Baseline %Difference: Max% Improvement:

*Statistically Significant

Day 28 8.03%* 22.03%

Day 56 11.40%* 26.80%

Baseline

Day 56

% of Improvement in Wrinkle Length & Depth: 23.69%

80.46%

% of Improvement in Wrinkle Length & Depth: 48.94%

68.94% 760.692.4729 main | 760.476.0600 fax | www.lifelineskincare.com

LIFELINE SKIN CARE, INC.

Baseline

Day 28

Day 56

% of Improvement in Wrinkle Length & Depth: 34.48%

55.29%

STUDY CONDUCTED BY
AMA LABORATORIES, INC. 216 Congers Road, Bldg. 1 New City, NY 10956 USA 845.634.4330 www.amalabs.com

REPORT REVIEWED BY

Tasmiya Masud, B.A. Quality Assurance Supervisor

Date

LIFELINE SKIN CARE, INC.

760.692.4729 main | 760.476.0600 fax | www.lifelineskincare.com