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| Results: |
There were no adverse dermal effects observed by the Principal Investigator, nor reported by the test panelists, at any time during or following the course of the study.
Highly significant (P<0.00) reductions in skin rebound time, indicative of improved skin elasticity, were obtained on both sides of the face following treatment.
A 21% reduction was observed in the mean rebound times for the left eye area, while a 15% reduction was observed for the right eye area. These reductions are considered evidence of significant improvements in skin firmness. |
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| Summary: |
A single treatment with the Miracle Wave Beauty Treatment Device was found to effect highly significant improvements in skin elasticity/firmness and to provide varying degrees of restoration in skin smoothness for each test panelist. Amelioration in eyelid sagging was also observed in several panelists. Post-treatment questionnaire responses were overwhelmingly positive following a single treatment with the instrument. There were no clinically meaningful adverse responses observed or experienced by any of the test panelists. |
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| Methodology: |
Twenty-two (22) test subjects were empanelled on this study. Skin firmness evaluations were performed at the following time points:
- Baseline, just prior to use of the instrument.
- Approximately 5-minutes following the 20-minute treatment with the Miracle Wave procedure.
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For seven (7) days prior to Day 0 of the study, subjects cleansed their face two (2) times daily with Neutrogena® soap, supplied by the testing facility. The application of all skin care products, including moisturizers to the test areas, was discontinued.
On Day 0, subjects reported to the laboratory and cleansed their faces with mild soap and warm water, being sure to rinse well. The face was gently patted dry with soft paper toweling. Following cleansing, subjects acclimated to ambient conditions (Temp. 70°F [±2°F] R.H. 40 [±2]) in a temperature/humidity-controlled room for 15 minutes.
Immediately following the acclimation period, photographs were taken of the eye and naso-labial fold areas. Skin firmness (elasticity) scores were obtained by the Principal Investigator by measuring the time required for an elevated fold of skin, held between the thumb and forefinger, in the lateral sub-orbital area of both eyes, to recover their previous conformation when released. The elevated fold of skin was held for approximately one second before release. Timing was performed using a stopwatch measuring to one-hundredth of a second (0.00). The stopwatch was started simultaneously with the release of the skin fold and stopped when all visible recovery motion of the skin had ceased.
The first (pre-treatment) firmness/elasticity scores were considered "Baseline" values for each test panelist. Improvements in skin "firmness" were considered significant when there was a statistically significant (P<0.05) difference between the baseline and post-treatment scoring intervals. All skin firmness scores were recorded on individual panelists' evaluation forms.
Skin smoothing and reduction in fine and/or deeper wrinkling were recorded by use of before and after treatment photographs, taken of the right and left "crow's feet" areas of both eyes and the right and left naso-labial fold areas of both sides of the face. A variety of photographic procedures were used (Polaroid®, digital, 35 mm) during the test procedure.
Use of the test device was conducted by two trained and experienced instrument (Sponsor) operators. Treatments were applied while each panelist was lying in a comfortable position, on a padded table, with a pillow. Wave type settings were automatically advanced from settings 1 through 3 per instrument specifications.
The actual treatment phase of the study required approximately twenty minutes per test subject. The test subject remained in temperature/humidity controlled room for both the pre- and post-application test intervals.
Following completion of post-treatment questionnaires, the panelists had three moisturizing products applied to various areas of the face, (Flexia Clear Essence, Flexia refresh lotion and Flexia moisture drops), to further refresh the post-treated faces. |
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The test was conducted by Consumer Product Testing Co.,
Fairfield, New Jersey on June 6-7, 2002. |
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