High Frequency Clinical Studies 

A number of clinical studies on the High Frequency have been carried out both by Omega and by other laboratories. Copies of some of those studies are included on these pages:

Clinical Study of the High Frequency and Its Effect on Pore Size
Clinical Study - Pore Size, Puffy Eyes and Fine Lines
Clinical Study - High Frequency and Pimples
High Frequency - Ozone Production Tests

Clinical Study High Frequency Effect on Pore Size
By Dr. M. L. Langton

Introduction
The use of high frequency current in the cosmetic industry has been observed to reduce the appearance of facial pore size. The purpose of this study was to investigate, through double blind trials, the actual ability of the technology to achieve these goals. 

Procedure
The study began with 32 subjects (16 treated, 16 control). By the time the study was completed, only 28 subjects remained (15 treated, 13 control). 
Each subject was given a skin care regime which consisted of a cleanser (Primary Solution Cleanser) and a Derma Wand high frequency esthetic tool. The treatment subjects were given a fully operational Derma Wand and the control group was given a Derma Wand which was fitted with an incandescent light bulb. 

All of the subjects were female and they ranged in age from 29 to 58 years.

The subjects were instructed on how to use the Derma Wand and told to use their normal skin care regime. The instructions were to use the Derma Wand in the morning and in the evening. Each subject was to record the length of time the Derma Wand was used during each application as well as the balance of their skin care regime.

At the beginning of the study, pore size was measured using a magnified projection image. This device shines a high powered light onto the surface of the skin. This light is viewed through a gradated lens. This provides a measurement of the pores diameter to within ±15% accuracy. However, measurement of the curvature of the pore is not possible with this method. To obtain this a qualitative scale of rough, medium or smooth was used.

Each subject was seen weekly over a 6 week period to determine their progress. 

Results
The attached table provides the results of the weekly measurements for the 28 subjects who completed the study. The results show a reduction in pore size of 33% for the test group compared to 6% for the control group. These results are shown graphically below:

High Frequency Clinical Study: Pore Size, Puffy Eyes and Fine Lines

Introduction
The Derma Wand is a condensed version of the high frequency skin care technology that is used by skin care professionals world wide to enhance the appearance of skin. This study is being undertaken to quantitatively establish that published results that are attributed to high frequency are demonstrably associated with the Derma Wand. Further, the study attempts to determine the effects of the Derma Wand when used with various skin cream regimes.

The benefits that are quantified in this study are: 

1. Pore size improvements
2. Improvements in the appearance of puffy eyes.
3. Improvements in the appearance of fine lines.

Procedure
The study involved 26 subjects, 25 female and 1 male. 

1. On the first day the subjects were brought in and randomly assigned a subject number. Then each of the participants was evaluated by the esthetician and their dermal characteristics recorded on the participant data sheet. Any proposed participant who showed signs of Cuperous or Rosacea, was eliminated from the study at this time.

The original protocol allowed for 28 participants. As only 26 were available, number 12 and 24 were not used.

The following table outlines the treatment received by each of the participants:

As can be seen, the participants were required to treat each side of their face separately.

2. The participants were each photographed using a Kodak DC 210 digital camera to provide a full face frontal shot. This picture was for identification purposes only.

3. Next, a +6 Tamaron lens was put in front of the digital camera lens and a close up picture of the left and right sides of the face were taken from a fixed distance of 8 inches.

4. The subject underwent a treatment and the photographs were repeated. For each day of the study, the subject received a treatment in the clinic each morning and was expected to undertake the treatment, on their own, at home each evening.

The treatment consisted of:

a. Cleanse with Cleanser.
b. Two minute general sweep with the Derma Wand over the appropriate side of the face.
c. Moisturize with appropriate product.
d. Two-minute sweep with the Derma Wand on appropriate side of the face.
e. Apply appropriate treatment product.

5. The photographs were electronically transmitted to the technician for evaluation. The technician was not informed which data corresponded to which treatment.

6. Once the first day’s data was received by the technician 3 areas for study were determined:

A. Eye Sagging. 
The computer program automatically: 

i. Draws a line from the corner of the eye to the point of inflection on the bridge of the nose.
ii. Measures the length of that line to adjust for irregularities in the rotation of the lead.
iii. Drops 2 vertical lines from the horizontal and adjusts for any tilt of the head.
iv. Measures the distance from the maximum point of sag to the point of minimum sag.

B. Pores During the initial evaluation the technician selects a location for analysis where pore dimensions are visibly evident. This selected area is then transformed into a black and white field. The photographs are run through a 3-step transform process:

i. the image is converted to monochromatic.
ii. a custom pixel filter is applied to increase the contrast substantially
iii. the image is reversed to allow for measurement of the High pixels.

The black area represents the pores. And the area of black is calculated to provide the pore score.

B. Dermal Crease: This evaluation is done exactly the same as the pores except that an area of pronounced dermal creases in the eye area is used.

Analysis

The data was then passed over to the analyst where it was reassembled with the clinical treatment schedule and then plotted. Each of the daily scores for like treatments, no matter which side of the face, was normalized by dividing the score by the day 1 score and plotted. Those curves are included in the appendix.

Results

The attached curves present the results of the tests for each of the 6 groups in each of the 3 areas of study. The following curves summarize the results for the 3 areas of study for the average of each of the 6 groups:

Conclusions

Eye Sagging:
The results for eye sagging are the most dramatic of all of the tests undertaken.  In these tests the use of the Derma Wand produced a reduction of over 60% in each of the average samples.  While there was a slight reduction in sagging through the use of the lotions alone, it was almost negligible compared to the Derma Wand results.

Pores:
The average reduction in pore size for each of the 6 groups was:

DW & 4 Step System 58.5
DW & Inexpensive Moisturizer  65.6
DW & Expensive Moisturizer 69.3
4 Step System 75.2
Expensive Moisturizer 79.0
Inexpensive Moisturizer 83.0

While the results for each of the groups was not as dramatic as the eye sagging experiments, there is a clear improvement, 13 to 17 percentage points, in the use of the Derma Wand over the lack of use of the Derma Wand. As well, The Derma Wand, when used with the 4 step program, provided results that were 7 % better than either of the other creams.

Dermal Creases:
The average reduction in Dermal Crease size for each of the 6 groups was:

DW & 4 Step System 60.2
DW & Inexpensive Moisturizer  72.1
DW & Expensive Moisturizer 72.3
4 Step System 83.9
Expensive Moisturizer 92.9
Inexpensive Moisturizer 93.3

Again, there is a 24 percentage point reduction in the size of the dermal crease when the Derma Wand is used. Also, the 4 step program is 10% more effective than either of the other creams.

Sven Budzisch P. Eng.
October 22, 1999

High Frequency Blemish Clinical Study

Introduction
The Derma Wand is a condensed version of the high frequency skin care technology that is used by skin care professionals world wide to enhance the appearance of skin. This study is being undertaken to quantitatively establish that published results that are attributed to high frequency for the remission of blemishes are demonstrably associated with the Derma Wand. 

Procedure
The study began with 100 subjects. Of these, 93 subjects, 50 female and 43 male completed the study. The subjects were randomly divided into active and placebo resulting in 68 active and 25 placebo. The ages involved in the study were from 14 to 38 years with the majority being in their teens. The following diagram illustrates the age/sex distribution of the participants:

The participants were divided into three groups where: 
          Group 1 received treatments using a placebo Derma Wand 
          Group 2 received treatments with a functional Derma Wand 
          Group 3 received treatments with a functional Derma Wand and Derma Lotion

A.  Each subject was initially evaluated and measured using the procedure described below: 

1. The subject was photographed in profile using a Kodak DC210 digital camera.  Photographs of the right side of the of the face and the left side of the face were taken. 
 
2. The images were then input to a computer using Adobe PhotoShop and the images were printed on an Epson Stylus Color IIs printer. 
 
3. The number of blemishes appearing on the subject's face was counted and recorded. In the event that the blemishes extended to the neck, the photograph was marked to record the line up to which blemishes were included. 
 
4. Using a Mitutoyo CD-6P Digimatic vernier, the diameter of each blemish was measured and recorded. 
 
5. The subject received a score equal to the sum of the diameter of the blemishes appearing on the face. 

B.  The subjects were each given treatments by our esthetician. The treatment consisted of: 

Group 1 received treatments using a placebo Derma Wand
     1. Cleanse with Primary Solution Cleanser. 
     2. Two minute general sweep with the placebo Derma Wand over the entire face. 

Group 2 received treatments with a functional Derma Wand 
     1. Cleanse with Primary Solution Cleanser. 
     2. Two minute general sweep with the functional Derma Wand over the entire face. 

Group 3 received treatments with a functional Derma Wand and Derma Lotion 
     1. Cleanse with Primary Solution Cleanser. 
     2. Cover the entire face with Derma Lotion. 
     3. Two minute general sweep with the functional Derma Wand over the entire face. 

C.  After each treatment, a second pair of digital photographs was taken and the above measurements were repeated. 

Treatments were conducted twice daily on each subject, between 7:00 AM and 8:00 AM and 5:00 PM and 6:00 PM each day. The treatments lasted for a period of 10 days. 

During the test, there were a number of days where the treatments could not be conducted due to illness or other personal circumstances. Because the duration of the test was so short, if a subject missed a treatment, they were dropped from the test. 

Results

The graph above presents the average standard results for the three groups. This was calculated by taking the average sum for each group for each day as a percentage of the average sum for the first day. 

Conclusion

There is a dramatic improvement in the average condition of the participants compared to the control sample. Quantitatively, the average improvement was to a level of 35% of the original evaluation. While there is a marginal additional improvement in the group who used the lotion as well as the Derma Wand, the difference is not large and the results appear to be converging on the results of the group that used the Derma Wand alone. 

Every participant who used the Derma Wand had a significant reduction in his/her blemish score indicating that most people will see reduced blemishes when using the Derma Wand. 

Christopher Hatton P. Eng. 
July 2, 1998

High Frequency - Ozone Production Tests

Purpose
The purpose of the tests was to determine the rate of production and dissipation of ozone as produced from the Derma Wand. 

Procedure
The Derma Wand was placed into a series of cubical containers along with an ozone meter as depicted in the following sketch: 

Three different sized containers were used:  
     1.   12" X 12" X 12"  
     2.     6" X   6" X 6"  
     3.     3" X   3" X 3"  

The Derma Wand was grounded and placed at the bottom of the container, directly below the ozone sensor.    

Results  
The first series of tests were run in the  12" X 12" X 12" container.  In this enclosure, after 1 hour there were no readings.

Next, the 6" X 6" X 6" container was used.  The results in this container are depicted below:

In the 3" X 3" X 3" container, the readings quickly (within 2 seconds) went to 0.28 ppm and remained there for over 30 minutes. 

The above diagram illustrates the decrease in ozone once the Derma Wand was turned off: 

Ozone Toxicity
Ozone is an irritant of the mucous membranes and the lungs. Effects of exposure can be wide ranging. Signs of exposure increase as follows: 

• Odour Threshold .01 ppm 
• Obvious Odour .05 ppm 
• At 0.1 ppm 5% of people will experience eye irritation 

The following scales represent the exposure time required to produce the listed toxic effects. The scale is the product of dose in ppm and time of exposure in minutes. The most severe application of the Derma Wand is 0.70 ppm-minutes and this would occur if the user were to inhale all of the ozone produced during a 5 minute treatment. 

0.65 to 3 ppm-minutes 
• throat irritation 
• throat dryness 
• watering eyes 

3 to 36 ppm-minutes 
• changes in visual acuity 
• increase in peripheral vision 
• coughing 
• choking 
• substernal pain 
• dyspnea 

36 to 72 ppm-minutes 
• head ache 
• dizziness 
• burning eyes 
• pulmonary edema 
• broncho pneumonia 

72 to 96 ppm-minutes 
• impaired lung function 
• ionizing radiation mimicking 
• chromosomal damage 
 
6,000 ppm-minutes 
• potentially lethal   

12,000 ppm-minutes 
• LC50 in rats 

Legislated Limits 
United States National Ambient Air Quality Standard - hourly average of 0.12 ppm 
(7.2 ppm-min)1 

Maximum standard for ozone in the workplace (TLV) .05 ppm for 8 hours 
(24 ppm-minutes)1 

1 Kehrer, in handbook on TOXICITY OF INORGANIC COMPOUNDS 
(Marcel Dekker, Inc.) 

TLC-TWA 0.1 ppm2 

ACGIH, NIOSH, MSHA 0.2 ppm2 

OSHA IDLH 10 ppm2 

2 Pradyot Patnaik A COMPREHENSIVE GUIDE TO THE HAZARDOUS PROPERTIES OF CHEMICAL SUBSTANCES, Van Nostrand Reinhold 

Conclusion
If the Derma Wand is operated in an open environment there is no chance that ozone can build up to levels which would be harmful. Further, the quantity of ozone generated by the Derma Wand during a most severe application is lower than the lowest levels at which any sign of physical effect can be seen. This compares well with the effects of our application studies where no negative effects associated with the wand were observed. 

C. W. Hatton P. Eng.