HEC Elasticity and Viscoelasticity Cutometer Clinical Study

1. OBJECTIVE

The purpose of this study was to evaluate the efficacy of a topically applied product when tested immediately after a single use on a group of 15 subjects under ambient conditions. Effectiveness of the test product was evaluated objectively via bio-instrumental measurements. Elastic and viscoelastic properties of the skin were measured as a function of skin flexibility and firmness employing a cutometer.

2. ELASTICITY AND VISCOELASTICITY CUTOMETER RESULTS

2.1.– RO READINGS

Cutometer readings (R0) show that the test material reduced final distention at each evaluation time point, with an average reduction of 8.03% after immediate application. The decreases are considered statistically significant at all time points. A decrease in the R0 parameter is indicative of improved skin firmness, thickness, and tightness.

RO – IMPROVED SKIN FIRMNESS, THICKNESS, AND TIGHTNESS

*Statistically Significant (p<0.05)

2.2.– R2 READINGS

Cutometer readings (R2) show the test material improved gross elasticity immediately (15 min) after application, with an average improvement of 11.36%. Increase in R2 parameters are indicative of improved skin elasticity.

R2 – IMPROVED GROSS ELASTICITY

*Statistically Significant (p<0.05)

2.3.– R5 READINGS

Cutometer readings (R5) demonstrated significant improved in net elasticity, with an average improvement of 4.83% after immediate (15 min) application. Increases in R5 parameters are indicative of improved skin elasticity.

R5 – INCREASE IN NET ELASTICITY

*Statistically Significant (p<0.05)

2.4.– R7 READINGS

Cutometer readings (R7) demonstrated that the test material significantly improved biological elasticity, with an average improvement of 4.63% after immediate (15 min) use. Increases in R7 parameters are indicative of improved skin elasticity.

R7 – INCREASE IN BIOLOGICAL ELASTICITY

*Statistically Significant (p<0.05)

3.0 INSTITUTIONAL REVIEW BOARD [IORG0011153] [IRB00013226]:

Reference: CFR Title 21 Part 56, Subparts A, B, C, and D. The IRB of consists of 5 or more individuals, chosen from within the company 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.

4.0 PANEL SELECTION:

4.1. STANDARDS FOR INCLUSION IN THE STUDY

a. Males and females between 35 and 70 years old.

b. Individuals who completed a preliminary medical history and screening document as mandated by Advanced Science Laboratories, Inc.

c. Individuals, who read, understood and signed an informed consent document as required by CFR Title 21, Part 50, Subpart B regulations. Consent forms are kept on file and are available for examination on the premises of ADVANCED, only.

d. Individuals in general good health and free of any health problems, including neurologic, dermatologic, or systemic disorder that in the opinion of the Study Director would make study participation inappropriate.

e. Individuals who abstained from shaving or waxing the test site at least 72 hours prior to test commencement and throughout the study.

f. 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.

g. Individuals who agreed to limit their sun exposure and wear sun-protective clothing whenever possible.

h. Individuals who agreed to use only the assigned test product during the test period.

i. Individuals who agreed to use only the lab issued Cetaphil® soap during the 7 day of washout period and the entire remaining test period.

j. Individuals able to cooperate with the Investigator and research staff, willing to have the test material(s) applied according to the protocol and complete the full course of study.

5.0 PANEL DEMOGRAPHICS:

Fifteen (15) subjects were selected for this study:

Number of subjects enrolled .............................................................................. 15
Number of subjects completing study ................................................................ 15
Age Range ................................................................................................. 32 - 67
Sex .................................................................... Female ................................... 12
Race .................................................................. Caucasian .............................. 10
Hispanic ................................... 4
Asian ........................................ 1

6.0 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 liberally to the entire face.”

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. Skin in the face area was designated as the test area for Bioinstrumental Measurements.

SKIN ELASTICITY – CUTOMETER
(Courage+Khazaka, Model: SEM 575 SN: 32 98 1036)

A Cutometer SEM 575 (Courage + Khazaka) is used to measure skin viscoelastic properties. The measuring principle of the Cutometer is based on a suction method, in which negative pressure, regulated between 20 and 500mbar, deforms the skin mechanically. Skin is drawn into a calibrated aperture (Suction Phase; T1-T2) and after a defined time released (Relaxation Phase; T2-T3), (refer to Fig.1). Inside the probe, penetration depth is determined by a non-contact optical measuring system, which consists of a light source and a light receptor as well as prisms facing each other. Light intensity varies due to penetration depth of the skin. Resistance of the skin to the negative pressure (firmness) and its ability to return into its original state (elasticity) are displayed as curves (refer to Fig.1) in real time during the measurement.

PHASE 1:
SUCTION (when constant negative pressure is applied; T1 - T2)

During the suction phase, mechanical deformation is created. This results in skin’s immediate and delayed distention.

Immediate distention at T1 is described by Ue parameter and represents elastic deformation of the skin. Delayed distention, where skin “creeps” into the probe, takes place between T1 and T2 and is described by Uv parameter representing viscous deformation.

Elastic deformation together with viscous deformation is described by Uf (also called R0) parameter and represents maximum penetration of the skin into the probe.

Note: As skin elasticity increases, Uv decreases. Uv increases with age.

PHASE 2:
RELAXATION (when negative pressure is cut off; T2 – T3)

During the relaxation phase, negative pressure is cut off. Complete relaxation is represented by the Ua parameter, which can be further divided into immediate elastic return (Ur) and delayed viscous return (Ua – Ur).

R2, R5, R7 and R0 parameters are evaluated during this study. R2, R5 and R7 address skin elasticity, and demonstrate negative correlation with age. R0 parameter addresses skin firmness and tightness.

Additional R–parameters (R6, R8 and R9) may be included in this investigation at the discretion of study director.

Fig1. Skin deformation curve (in mm/time) obtained with a Cutometer.

R2 – Gross elasticity (relative parameter), also called overall elasticity of the skin including the viscous deformation. R2 determines ability of the skin to return to its original state after deformation. The closer R2 is to 1 (100%) the more elastic the skin is.

R5 – Net elasticity (without the viscous deformation) is a relative parameter between Elastic Recovery (Ur) and Elastic Deformation (Ue). R5 represents elastic recovery of the skin to return to its original position after deformation. The closer R5 is to 1 (100%) the more elastic the skin is.

R7 – Biological elasticity (relative parameter). R7 determines ability of the skin to return to its original position after deformation. R7 is represented by the ratio of Elastic Recovery to Elastic and Viscous Deformation.

R0 – Final Distension of the skin which represents passive behavior of the skin to applied force. It is an absolute parameter dependent on skin thickness. When R0 decreases, skin thickness, firmness, and tightness increase.

3. REFERENCES

Agache, P.G., et al. “Mechanical properties and Young’s modulus of human skin in-vivo.” Arch. Dermatol. Res., 269, 221, 1980.

de Rigal, J. and Leveque, J.J. “In vivo measurement of the stratum corneum elasticity.” Bioeng. Skin, 1, 13, 1985.

Akhtar, N, et al. "Calendula extract: effects on mechanical parameters of human skin." Acta Pol Pharm 68.5 (2011): 693-701.

Disclaimer: This document is a summary of an Hydrolytic Enzyme Complex 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.