HEC Skin Sampling D-Squame Study

1.0 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. The scaliness level of the skin via D-Squame Surface Sampling Discs.

2.0 D-Squame Skin Sampling Discs 
(D-Squame Standard Sampling Discs D100; 0.875 inch diameter)

Adhesive discs take the trial and error out of sampling the cells of the superficial stratum corneum (top layer of skin). These crystal-clear discs provide the required rigidity and adhesion to uniformly sample a fixed area of skin surface. The clear polymer discs provide optimum visibility of adhering skin cells and allow staining by many histological preparations.

D-SQUAME disc is applied to clean, dry skin surface. It is pressed firmly for a few seconds using thumb or fingertips, and then transferred to a black square on the storage card where is compared with reference patterns. Heavy amount of scaling represents pattern 5. Normal skin producing a few areas of small clumps of cells or a fine even single layer of cells represents pattern 1. The source data were totaled and reported as average scores (where applicable). Moreover, the data obtained was quoted as % differences from baseline or from each of the previously described time points (where applicable).  A within group comparison of baseline measurements with post-treatment measurements was analyzed using a (two-tailed, paired) t-test, (p<0.05).

2.1 D-SQUAME Assay Results 

Immediately (15 mins) after application, the Hydrolytic Enzyme Complex significantly reduced skin scaliness by 46.15%.

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.

*Statistically Significant (p<0.05)

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. Elastic and viscoelastic properties of the skin were measured as a function of skin flexibility and firmness employing a Cutometer; skin surface lipids were measured via Sebumeter; scaliness level of the skin via D-Squame Surface Sampling Discs.Cutometer and Sebumeter® measurements, together with D-Squame readings were performed prior to the application of the test product at Baseline, and again 15 minutes immediately after a single use.

 

Disclaimer: This document is a summary of a Hydrolytic Enzyme Complex study performed by an independent third-party testing facility. We believe the information provided here is correct but past performance is not necessarily indicative of future results.