DermaPlus clinical trial of its anti-aging product DermaLastyl-βx Pro/Face cream

A very significant reduction in all parameters measured, demonstrates the effectiveness of DermaLastyl-βx Pro/Face of increasing the smoothness of the skin.

Profilometry provides the confirming, quantitative support for improved appearance in subjects skin. The most common measure of performance in the US, (Ra) was reduced by a highly significant 25% after 12 weeks of treatment.

Abstract:

Profilometry is the use of a laser or white-light and computer-generated projections to perform surface measurements of three dimensional objects, like the surface of the skin.

DermaPlus undertook a clinical trial of its anti-aging product DermaLastyl-?x Pro/Face cream. Thirty five volunteers used the product on their skin for 12 weeks and skin smoothness was evaluated using the PRIMOS Profilometry in vivo skin profiling system. All 35 subjects completed the trial, and 83% of the volunteers showed significant improvement in skin smoothness and reduction in the appearance of fine lines and wrinkles as assessed by laser profilometry and self assessment.

Procedure:

A study protocol was developed to evaluate the effectiveness of DermaLasyl-Bx Pro Formula Face Cream in improving the appearance of facial skin and reducing the appearance of fine lines and wrinkles. The crow's feet area was chosen for detailed evaluation. The study was performed using 3-D Profilometry measurements under the supervision of Dr. Steven Lamm. Thirty-five subjects with visible fine lines around the eye area were identified and invited to participate in the 12-week study. All of the subjects completed the study.

The volunteers were asked to visit the office of Dr. John Hunter, cosmetic surgeon and review and sign an Informed Consent Form, The subjects were provided with their supply of DermaLastyl-?x Pro Formula along with instructions for use and were imaged with a Primos 3-D Profilometry Optical Imaging system operated by Canfield Scientific Inc. The subjects returned after 6 and 12 weeks for follow-up profilometry imaging and evaluation, and were asked to complete a self-evaluation form and interview during the final 12-week visit.

Study Design is shown in Figure 1.

Data Analysis:

A subset of subjects (29) were selected for Roughness and Volume measurements. The average roughness and volume before and after treatment was averaged over the subset of volunteers to provide a statistically significant measure of performance. Three different texture equations were used to analyze the data: Ra (roughness average), Rz (average roughness depth) and Rmax (maximum roughness).

Results:

Self-assessment. All 35 subjects were asked to complete a self-assessment form comprising of 14 questions during their final visit. The first 10 questions addressed the subject's personal evaluation of DermaLastyl-βx Pro/Face's performance on their skin. The responses ranged from 97% agreeing with the statement "I experienced a more youthful appearance" to 77% agreeing with the statement "Pro/Face makes my skin firmer than before". A graph of the responses to all 10 questions is shown in Figure 3.

Figure 3. Percentage self-assessment positive responses to 10 questions.

3-D Profilometry.

The profilometry data collected during the initial and final visits of the study in Figure 4 shows a black and white virtual image constructed from the data for one subject.

Figure 4. Profilometry image before and after treatment.

False-color images highlighting the smoothness of the skin and the length, depth and extent of fine lines and wrinkles were created using the profilometry data and proprietary software. The analysis of these images gives a quantitative measurement of the performance in both improving the roughness of the skin and determining the percentage reduction in wrinkles in the crow's feet area. A topographic color image of this area shown is displayed in Figure 5.

Figure 5. Topographical image of skin roughness, fine lines and wrinkles before and after treatment.

Analysis of the data in this image can be used to generate values for Ra (roughness average), Rz (average peak to valley roughness depth) and Rmax (maximum roughness). The values for these parameters of the image are shown in Table 1. A very significant reduction (17 - 25%) in all parameters was measured, demonstrating the effectiveness of DermaLastyl-βx Pro/Face in increasing the smoothness of the skin.

Table 1. Percent reduction in R values during DermaLastyl-β Pro/Face treatment.

Conclusions.

This study demonstrates that regular use of DermaLastyl-βx Pro/Face results in a benefit to a large majority (83%) of users. Self assessment provided evidence of efficacy in improving the skin's smoothness and reduction in the appearance of fine lines and wrinkles, but this information is subjective. Profilometry provides the confirming, quantitative support for improved appearance. Ra, the most common measure of performance in the US, was reduced by a highly significant 25% after 12 weeks of treatment.

References.