Abstract:

DermaPlus undertook a clinical trial of its anti-aging product DermaLastyl Pro/Face cream. A Total of 35 volunteers were treated with the product for 12 weeks and skin smoothness was evaluated using Digital Photography and 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 analysis of 2-D digital images taken at the beginning and end of the study. These results were quantitatively confirmed by analysis of the results of the laser profilometry study.

Procedure:

A study protocol shown in (Appendix A) was developed to evaluate the effectiveness of DermaLasyl-Bx Pro Formula Face Cream in improving the appearance of the face 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 2-D Digital Photography with Image Analysis plus 3-D Profilometry measurements (Appendix B) 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 (Appendix C), The subjects were provided with their supply of DermaLastyl Pro Formula along with instructions for use and were imaged with a VISIA CR 2-D Digital Imaging Booth and a Primos 3-D Profilometry Optical Imaging system operated by Canfield Scientific Inc. The subjects returned after 6 and 12 weeks for follow-up digital and profilometry imaging and evaluation, and were asked to complete a selfevaluation form (Appendix D) and interview during the final 12-week visit. The

Study Design is shown in Figure 1.

Study Design Profilometry study (fine line and wrinkles)
Study Design	Test product vs. baseline
n:	35 subjects to complete with approximately 30 subjects
Test site:	Crows Feet Area
Time points:	-7 days, Baseline, 6 weeks, 12 weeks
Amount of Test Material Required	70 – 1.7 Oz units (enough for 16 weeks)
Subjects:	Women & Men with signs of Aging (visible fine lines and wrinkles in the crows feet area of the eyes)
Age:	35-60
Conditioning Phase,	1 week with Aveeno Soap
Claim	Instrument
Reduces fine lines and wrinkles (Profilometry)	PRIMOS 3-D T= baseline, 6 weeks, 12 weeks
Subjective Questionnaire with statistical analysis	Consumer Questionnaire T= 12 weeks
Improves appearance of skin and face (Photography)	2D Digital Photography and Image Analysis T= baseline, 6 weeks, 12 weeks

Data Analysis:

The digital images and profilometry data were correlated between the 2 data sets. The Digital Images of Before and After treatment were evaluated and a subset of subjects (29) 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:

2-D Imaging. The 2-D Digital images from all 35 volunteers completing the 12- week study were analyzed for improvement in the appearance of the skin and face and a reduction in the appearance of fine lines and wrinkles by a panel of Reviewers. Of the n = 35 subjects, 29 were judged to have benefited from the 12-week treatment by DermaLastyl Pro/Face (29/35 = 83% of the subjects showed improvement in the skin and reduction in fine lines and wrinkles). The improvement during DermaLastyl treatment on the crow’s feet area as evaluated by Digital Imaging comparison is shown in Figure 2.

Figure 2. Before and After Treatment.

Self-assessment. All 35 subjects were asked to complete a self –assessment form comprising 14 questions during their final visit. The first 10 questions addressed the subject’s personal evaluation of DermaLastyl 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 was correlated with the digital images. Figure 4 shows a black and white virtual image constructed from the data for one subject. This image shows the same subject and skin area as the digital photograph in Figure 2.

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 measure 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 three parameters was measured with this image, demonstrating the effectiveness of DermaLastyl Pro/Face in increasing the smoothness of the skin.

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

Parameter	Ra (µm)	Rmax (µm)	Rz (µm)
Before Treatment	45.3	289.8	190.7
After Treatment	33.9	238.4	145.5
Percent Reduction	25.1%	17.7%	23.7%

Conclusions.

This study demonstrates that regular use of DermaLastyl Pro/Face results in a benefit to a large majority (83%) of users. Both self assessment and review of Digital Photography 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. These results compare very favorably to the results found in profilometry studies of prescription treatments such as Botulinm toxin1 Tretinoin2 and Estrogen3.

References.

1. Luc Levy et. al. 2004. “Botulinum toxin A: a 9-month clinical and 3D in vivo profilometric crow’s feet wrinkle formation study” J. Cosmetic Laser Surg.6:1, 16-18.
2. Rachel, JD. et. al. 2003. “Skin rejuvenation regimens: A profilometric and histopathologic study” Arch Facil Plastic Surg 5:145-149.
3. Schmidt, JB et. al. 1996. “Treatment of skin aging with topical estrogens”. Int J Dermatol. 9:669-74.