2019 SKINSTIM CLINICAL PROTOCOL

Sponsor:  SkinStim, a unit of Leonhardt’s Launchpads by Cal-X Stars Business Accelerator, Inc.

Condition To Be Treated: Facial Wrinkles

Background:

The loss of facial skin smoothness, texture, and turgor that can occur with age or other reasons, often leads to the development of unwanted facial wrinkles. Current and previous treatments have been temporary or only somewhat effective in reducing wrinkles.

This multi-component regimen is the most scientifically based and cutting-edge approach to treat facial skin wrinkles. It includes the use of both devices and biologics. The centerpiece is Bioelectric Stimulation, which involves the use of four precise micro-current signals delivered to the skin that increase the local tissue expression of four pro-regenerative proteins or substances that are normally present in the skin, but become depleted with age. These signals will stimulate native skin repair by attracting stem cells, enhancing blood flow, and help to enhance skin elasticity and cellular repair.

The bioelectric stimulation will be delivered via a mask to be worn over the face that will deliver the micro-current at a strength and comfort level that will be selected by each patient. The biologics include a hydrogel cream that provides important enhancement to the texture of the skin, and the use of two of nature’s most important pro-regenerative substances, Platelet Rich Fibrin(PRF), which contains many growth factors to enhance the function of the stem cells mobilized to the skin, and Amniotic Fluid, which contains all the substances needed at birth to form skin and every tissue of the body.

The Platelet Rich Fibrin will be prepared from a small sample of your own blood and prepared on site in the clinic before you start treatment.

Treatment Safety:

Each of the components of this treatment regimen have received FDA 510K market approval based on demonstrated safety and efficacy. The combination of the components will not cause any adverse interactions but should be additive in benefit

Treatment Components:

1. Devices:
2. SkinStim Prizm Bioelectric Stimulator and electro massage gloves 
3. DermaPen micro needle array 
4. LED Light and microcurrent face and neck mask 
5. Biologics
6. Hydrogel based skin cream
7. Platelet Rich Fibrin (PRF)
8. Amniotic fluid

Treatment Eligibility:

Age: 30-75 yrs

Sex: Female or Male

Exclusion Criteria:

• Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a reliable form of birth control.
• Subjects who have had prior exposure to any hyaluronic acid, or any other filler, injection for any purpose in the 3 months preceding study enrollment through the duration of the study.
• Subjects who have had prior exposure to any botulinum toxin for facial rhytids in the 6 months preceding study enrollment through the duration of the study.
• Subjects who have had a prior cosmetic procedure to improve facial rhytids (i.e., rhytidectomy, periorbital or eyelid/eyebrow surgery, brow lift, CO2/erbium laser resurfacing, Thermage/Thermacool radiofrequency treatment) within 6 months or who have visible scars that may affect evaluation of response and/or quality of photography.
• Ablative skin resurfacing on the glabellar area within the previous 6 months or during the study.
• Retinoid, microdermabrasion, or prescription level glycolic acid treatments within 3 months prior to study participation or during the study.
• Oral Isotretinon within the past 12 months.
• Active cut, wound, or infection on the face.
• Active HSV-1.
• History of keloids or hypertrophic scarring.
• Existing or history of skin malignancy.
• Any existing facial skin disease.
• History of collagen or vascular disease.
• Patients who have used, within 30 days, any medication that can cause dermal hypersensitivity or affect skin characteristics.
• History of autoimmune disease.
• History of any disease that inhibits pain sensation.
• Patients who have implantable pacemaker, automatic implantable defibrillator (AICD), or any other implantable electric device.

Treatment Schedule/Components:

Each patient will be treated for a total of 3 months.

Bioelectric Stimulation (via face mask):

Month 1: Twice weekly for 30 minutes

Months 2&3: Once/week for 30 minutes

Platelet Rich Fibrin:

Obtained from a small sample of patient’s blood and prepared on-site and then Injected via a DermaPen microarray of needles into the targeted area of skin once per month including start of treatment and then each months 2 &3 of treatment.

Amniotic Fluid:

Non-manipulated source of AF to be Injected also via a DermaPen microarray of needles once each month including at the start of treatment and then months 2&3 of  treatment into the targeted area of skin

Hydrogel Cream:

This will be applied topically and massaged into the area of facial wrinkles at each of the bioelectric stimulation treatments.

Possible Side Effects of Treatment:

The strength of the bioelectric stimulation will be adjusted to a comfort level selected by each patient. The duration of treatments will be the same for each patient.

There is no history of any skin burn or irritation associated with the use of this low level bioelectric stimulation, and the biologics which will be injected or applied to the skin are derivatives of naturally occurring substances and also have no history of allergy, rash, or other adverse reaction.

Documentation:

Each patient will have a photo taken of their face with no makeup applied before and after the treatment period to document the benefit of the therapy.