Nova Dermal Phase Meter Clinical Study: Sculpting Cream

Nova Dermal Phase Meter Clinical Study: Sculpting Cream

1.0 OBJECTIVE:  

 

The purpose of this study was to evaluate the efficacy of the Aeonia Sculpting Cream when tested over a 14-day period under ambient conditions. Effectiveness of the test product was evaluated objectively via visual expert grading, and subjectively using panelist self-assessment questionnaire responses on a group of 37 subjects. Skin hydration was measured with the Nova Dermal Phase Meter. 

 

2.0 SKIN HYDRATION VIA NOVA DERMA PHASE METER:

 

A Nova Dermal Phase Meter, Model DPM 9003 (Nova, Technology Corp., Gloucester, Mass.) was used to obtain measurements of skin surface impedance to determine electroconductivity of the test sites. This meter provided a relative measure of the retained water content of the skin as a function of the skin's dielectric value. Skin impedance was recorded automatically when equilibrium is achieved.

Novameter readings of electroconductivity demonstrated the test material maintained an increased level of skin moisture content throughout the 14 days of product use.  

 

 

Relative Novameter Units

 

*Statistically Significant (p<0.05)

 

After maximum average moisture increase of 58.81% was observed 15 minutes (immediately) after initial application. After 24 hours and prior to a subsequent application, the average skin moisture was still significantly higher than the baseline, demonstrating 24-hour hydration.   

 

Relative Novameter Units

*Statistically Significant (p<0.05)

 

 

Relative Novameter Units: 24 Hours vs Baseline

*Statistically Significant (p<0.05)

 

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:  

  1. Females between 35 and 70 years old of varying ethnicities (skin types: all, I through VI).
  2. Individuals, who read, understood, and signed an informed consent document as required by CFR Title 21, Part 50, Subpart B regulations.
  3. 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.
  4. Individuals who agreed to use only the assigned test product during the test period.

 

5.2. KEY STANDARDS FOR EXCLUSION FROM THE STUDY: 

  1. 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.
  2. 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.
  3. Individuals known to be participating in other clinical studies.
  4. Individuals known to be employees of testing firms/laboratories or cosmetic/raw materials suppliers.
  5. Females who are pregnant, lactating, have been pregnant or given birth within the six-month period immediately preceding study commencement.
  6. Subjects with a history of any form of skin cancer, melanoma, lupus, psoriasis, connective tissue disease, or any disease that would increase the risk associated with study participation, at the discretion of the Study Director.
  7. Individuals with known allergies or skin and/or eye conditions, which would interfere with the study at the discretion of the Study Director

 

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: 

 

Leveque, J.L., de Rigal, J.: Impedance Methods for Studying Skin Moisturization, J. Soc. Cosmet. Chem., 34: 419-428, 1983. 

 

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.