V2 Clinical Study

By Doctor Robertson, MD

I am a practicing full-time Internist in Newport Beach, California. I have treated and overseen the treatment of multitudes of patients with acne vulgaris and related skin conditions using ZAPNE. All of these patients had already used many or all of the OTC and prescription drug products currently approved for acne, with inadequate, transitory, or otherwise unsatisfactory results. The acceptance and results of ZAPNE is superior to all the common and prescribed remedies that I have used. No adverse results have occurred and the rapid response of treatment is obvious to both the patient and treating physician. Additional benefits of treatment include homogenization of skin pigmentation, less oily skin, and peeling of the outer layer of damaged integument. Weekly applications have been well-tolerated and demonstrated good compliance.

My physician colleagues’ experience with ZAPNE is similar. Patient compliance and tolerance is excellent, and efficacy exceeded the other OTC and prescription medications with less cost and time required of the patient.

Clinical Open Label Study

In my private practice we have conducted an open label study with 50 patients with mild to very severe acne vulgaris. The purpose of this Pilot Study was to show cosmetic improvement of the acne-prone skin appearance with ZAPNE use for potential commercial promotion based on the photos “before and after.” The theorized and scientifically supported beneficial mechanisms that differentiate the ZAPNE protocol of treatment from other acne treatment protocols includes: ZAPNE helps to exfoliate the surface epithelium thereby unclogging pores, venting the closed environment that allows acne to expand, inflame and suppurate. This enhanced penetration of active ingredients into the compromised microenvironment of the follicle or pilosebaceous unit (PSB), allows the pore to breathe again. Sebum is both allowed to exit the pore while sebum production, a cofactor in acne promotion, is decreased. ZAPNE contains antimicrobials that are active against P. acnes, one of the primary germs that contribute to acne. This combination of unclogging pores, decreased inflammation, decreased sebum production and improved delivery of anti-acne compounds helps to tilt the balance in favor of a healthy follicle and the elimination of acne.

Materials and Methods

Patients with acne vulgaris who accepted our protocol and signed Testimonial Release Form were enrolled into open label clinical study comprising a total of 50 patients both genders, 16 to 50 years of age, and diverse ethnicity. All patients had a history of recurrent acne vulgaris and had various degrees of clinical severity, but were otherwise healthy. None of the patients received any topical or oral treatments within the last 2 weeks prior to entry into the study. The treatments were applied once a week in the office by MD or medical assistant under supervision of MD during the course of four to eight weeks. The primary efficacy endpoints were evaluated based on a standardized scale baseline in inflammatory lesion counts and the treatment success.* Measures also included patient’s global assessment of acne improvement, compliance checks, and information about adverse effects.

Discussion of Results

ZAPNE’s effect was noted soon after, and in many cases immediately after commencement of treatment, reaching significant reduction in lesion counts after as little as one week. Approximately ninety percent reduction in lesion count was noted after 3-4 weeks of treatment in patients with mild to moderate acne and after 8-9 weeks in patients with severe to very severe acne. (By comparison, Retinoids, the current “Gold Standard” in topical prescribed acne therapy, reduces lesions 50-60% after 12 weeks, and no significant effect can be seen after 3-4 weeks). No occurrence of skin irritation was noted in the Group of patients using ZAPNE.

ZAPNE’s efficacy, along with the excellent safety profile, supports the merit of continuous use of this product by acne-affected patients.

During the acne study we have also observed that ZAPNE effectively improves the appearance of seborrheic dermatitis, rosacea, and photo-aged skin after short treatment periods.

Yours truly,

Gregory A. Robertson, M.D.

* The primary efficacy endpoints was evaluated based on a standardized scale baseline in inflammatory lesion counts and the treatment success, defined as a score of clear or minimal with at least a 2-step reduction from baseline. Scores were assessed on the Investigator’s Global Assessment (IGA) scale.