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ISADERMIX SKIN RENEWAL

Summary of Clinical Studies

Summary of randomized, blinded, prospective and controlled Clinical Studies comparing classic microdermabrasion techniques using machines with IsaDermix Skin Renewal System.

Overview:

Microdermabrasion machines are proven tools in dermatology and have a wonderful track record for improving the condition and appearance of skin. The machines, however, are not friendly enough for home use, and their actual use is often questioned by patients with health concerns.

Dr. George Boris and Mr. Richard Fox set out to develop a special microdermabrasion system without the use of machines. The new IsaDermix Skin Renewal System, an at-home microdermabrasion and resurfacing kit, uses patented magnesium oxide crystals (aluminum-free) suspended in an elegant cleansing cream base.

The focus of ongoing clinical trials is to compare the overall clinical effectiveness of a proven microdermabrasion machine and the IsaDermix Skin Renewal System. The pivotal question was whether the new kit would be inferior, equivalent, or superior to the classic machine use.

Selection of Participants

More than 100 participants were chosen from both genders, wide-age variance, and multiple ethnicities. However, because of the proximity of the Culver City Surgical Center, the study was skewed toward persons who are active in the entertainment industry.


Materials and Methods:

The study was prospective, randomized, controlled, and blinded. Each patient experienced classic machine microdermabrasion on one side of the face and the "at home" microdermabrasion kit on the other side.

The machine uses high-speed aluminum particles to hit the skin much like "sand blasting" in an industrial setting. It uses an aluminum-based compound that is of health concern to many patients.

The "at home" microdermabrasion/resurfacing kit uses a patented magnesium oxide crystal (aluminum free) suspended in an elegant cleansing cream base. It is applied by the fingers to the skin in a circular motion to exfoliate the skin in a more controlled way than the machine operation.

The user stops short of moderate pain in this process. Before beginning the study, a single base line skin biopsy and photos were performed (week number 1).

At week number 5, the patient's skin was evaluated by a blinded evaluator. Evaluations were performed both subjectively and objectively (histology). The blinded "split face" tests were continued for a full 10 weeks. At week number eleven (11), the patients' skin were evaluated (again by a blinded evaluator) for appearance and biopsies were performed on both sides of the face. The so-called "after" photography was performed at week number eleven as well. Biopsies were stained with both the Trichrome stain (to observe the highly colored collagen) and elastin stain (to observe the less dramatic but still observable elastin distribution.)

Results and discussion:

Again, all photographic evaluations and histology readings were performed in a blinded fashion. Examining both the before and after photography as well as the multiple biopsies, both treatments showed dramatic improvement in skin appearance, collagen formation, and elastin distribution. Both treatment modalities are effective when the patient fulfills their obligation to attend all ten treatment sessions and when the machine or "at home" kit directions are followed correctly.

Conclusion:

All patients had bilateral improvement of skin, as compared with baseline, as evaluated through our blinded subjective evaluation scale and pre and post photographs. Histologically however, the IsaDermix™ Skin Care System showed results that were superior to the classic machine use. Elastin and collagen were significantly increased for both treatments, with IsaDermix™ being more so. Interestingly, collagen deposition was thickest at the epidermal/dermal junction where it is most important in relation to skin wrinkles. No complications reported for either therapy. The use of the kit is dramatically more cost effective than the ten visits to a professional office, thus making the dramatic improvements available to a larger segment of the population. There are many busy professionals that could afford the ten office visits but could not afford time away from work or obligations. Studies in progress are determining more specifically and quantitatively the improvement of fibroblast bundle building which is thought to reduce wrinkles.

Peter Driscoll, MD