Visioscan® Surface Evaluation Clinical Study: Sculpting Cream

1.0 OBJECTIVE:

The purpose of this study was to evaluate the efficacy of the Aeonia Sculpting Cream when used twicedaily and tested over a 28-day period under ambient conditions. Effectiveness of the test product was evaluated objectively on a group of 37 subjects. Surface evaluation of living skin (SELS) was conducted instrumentally using a Visioscan® image analysis system.

2.0 SURFACE EVALUATION OF LIVING SKIN VIA VISIOSCAN® (WRINKLES [SEW] AND SKIN SURFACE SMOOTHNESS [SESM]) RESULTS:

Surface Evaluation of Living Skin (SELS) has shown the test material reduced the average number, width and depth of fine lines and wrinkles and improved skin surface smoothness. Visioscan® measurements uncovered a statistically significant reduction in SEw parameter calculated from the proportion of horizontal and vertical wrinkles at all evaluation time points with the maximum average reduction of 18.17% and 23.13% after 14 and 28 days.

Surface Evaluation of Living Skin via Visioscan (Fine Lines and Wrinkles Reduction [SEw])

*Statistically Significant (p<0.05)

Moreover, calculation of the average depth and width of wrinkles concluded the test material improved skin smoothness as indicated by reduction in SEsm parameter. Following 28 days, the depth and width of wrinkles were decreased by 16.82%.

Surface Evaluation of Living Skin via Visioscan (Skin Surface Smoothness [SEsm])

*Statistically Significant (p<0.05)

Visioscan® images were collected for each subject at each time point. Typical examples of before and after Visioscan® can be seen below.

Baseline After 14 Days

3.0. TEST MATERIAL EVALUATION PRE-REQUISITE:

Prior to induction of a human test panel, toxicology, microbiology, or in-vitro performance spectra may be required to assess the feasibility of commencement as dictated by an Institutional Review Board (IRB).

3.1.1. Sponsor purports that prior to sample submission, test materials were approved by the Sponsor’s Legal and Regulatory departments for inclusion in this testing program, and that the following tests were conducted with no adverse results and the test data are on file at their premises and have not been made available to personnel:

USP or CTFA Preservative Efficacy Test or equivalent
90 Day Accelerated Stability and Container Compatibility Study
Fifty (50) person Repeat Insult Patch Test (RIPT) or equivalent

4.0 INSTITUTIONAL REVIEW BOARD [IORG0011153] [IRB00013226]:

Reference: CFR Title 21 Part 56, Subparts A, B, C, and D. The IRB consists of 5 or more individuals, chosen for technical expertise and from the local community for lay interaction. The list of IRB members is kept on file and is available for inspection during regular hours of operation.

5.0 PANEL SELECTION:

5.1. KEY STANDARDS FOR INCLUSION IN THE STUDY:

Females between 35 and 70 years old of varying ethnicities (skin types: all, I through VI).
Individuals, who read, understood, and signed an informed consent document as required by CFR Title 21, Part 50, Subpart B regulations.
Individuals who have abstained from using any anti-aging, sun-protecting and moisturizing products, including lotions, creams, and gels during the 7-day washout period and the entire duration of the study.
Individuals who agreed to use only the assigned test product during the test period.

5.2. KEY STANDARDS FOR EXCLUSION FROM THE STUDY:

Individuals who are under the care of a physician for conditions that would interfere with the test results, at the discretion of the Study Director.
Individuals curr ently taking medication that may mask or interfere with the test results, including the use of any anti-acne drugs, topical and oral retinoids, topical antibacterial agents, and any immunosuppressive drugs.
Individuals known to be participating in other clinical studies.
Individuals known to be employees of testing firms/laboratories or cosmetic/raw materials suppliers.

5.3. RECRUITMENT:

Panel selection is accomplished by advertisements in local periodicals, community bulletin boards, phone solicitation, electronic media, or any combination thereof.

6.0 PANEL DEMOGRAPHICS:

Thirty-eight (38) subjects were selected for this study:

Number of subjects enrolled .............................................................................. 38

Number of subjects completing study ................................................................ 37

Age Range ................................................................................................. 36 - 68

Sex .................................................................... Female ................................... 37

7.0 PROCEDURE:

A seven-day (7) washout phase was required prior to study commencement. During this phase, the daily wash procedure was standardized in all subjects. Participants were instructed to use only lab-issued Cetaphil® soap. Additionally, as a condition of enrollment, only the subjects who abstained from using anti-aging, sun-protecting or moisturizing products throughout the entire study period including the washout phase were recruited for participation.

The participants were also required to limit sun exposure and wear sun protective clothing whenever possible. On the initial day of the study, upon arrival at the testing facility, subjects were required to familiarize themselves with, then sign an informed consent. Panelists were mandated to adhere to all the restrictions mentioned in the inclusion/exclusion sections (refer to 5.1 and 5.2). All participants were advised of the general nature and purpose of this study. The subjects were then acclimated to the ambient environment for a period not less than fifteen (15) minutes prior to baseline evaluation and biophysical measurements. The acclimation procedure was repeated for each subsequent evaluation time point.

The study was conducted according to Sponsor’s requested design wherein all subjects received written and verbal instructions regarding product use and study restrictions. Subjects were required to use the test material as a part of their daily routine according to the following sponsor supplied instructions:

“Apply lotion liberally to the face, avoiding the eye area, twice daily.”

Each product was weighed and recorded on a Product Weight Log prior to study initiation and again upon study completion to establish a use determination.

8.0 REFERENCES:

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.

Mike Farwick, Ursula Maczkiewitz, Peter Lersch, Tim Falla, Susanne Grether-Beck, Jean Krutmann; An ECderived Tetrapeptide to Counterbalance ECM Degeneration; Cosmetic & Toiletries magazine, Vol 124 Np. 6/June 2009.

Disclaimer: This document is a summary of an Aeonia Sculpting Cream clinical trial performed by an independent third-party clinical testing facility. We believe the information provided here is correct but past performance is not necessarily indicative of future results.