Zeno
This page will discuss Acne and the role of P. acnes in Acne Formation, Laboratory Studies of P. acnes’ Heat Shock Reponses and ClearPoint Technology™, the Clinical Testing done to establish the safety and efficacy of Zeno™ vs. predicate devices including comparative results vs. a placebo device and a Description of Zeno and the Zeno Treatment Tip. Zeno™ is indicated for the treatment of individual acne pimples in persons with mild to moderate acne.Acne and the Role of P. acnes in Acne Formation:
Acne is pustular eruptions, localized abscessed formation and local inflammatory conditions of the dermis and epidermis skin layers. Endogenous hormones (mainly androgens), which are present in unusually high concentrations in the blood during adolescence and puberty give rise to an excessive production of sebum (or oil). The condition may worsen by a simultaneous increase in the rate of keratin in the skin’s outer layer (the horny layer) that causes skin cell death. As the horny cells proliferate, they can form an occlusive plug or comedone which coupled with the increased production of the sebum, represents an ideal medium for the proliferation of the skin resident anaerobic bacterium, P. acnes.Plugged follicles may take the form of either 'whiteheads,' where the plug in the follicle remains beneath the skin’s surface, or 'blackheads,' where the plug in the follicle extends to the skin’s surface and becomes visible. In the majority of these clogged follicles, the bacterium P. acnes will cause swelling, itching, and redness around the follicle.
The bacterium P. acnes is normally present in all skin types as part of the skin’s sebum maintenance system. In a hair follicle, P. acnes produces enzymes that break down sebum creating a balance of oil in the skin. However, a clogged follicle creates an ideal environment for this sebum-eating skin bacterium to multiply. Consequently, the increase of P. acnes and its enzymes irritates and inflames the skin resulting in acne. Furthermore, P. acnes is responsible for at least 90% of all acne cases.
Laboratory Studies of P. Acnes’ Heat Shock Response:
With Tyrell’s ClearPoint technology, P. acnes is destroyed by a process called heat shock response. Heat shock response is a reaction bacteria have to heat whereby they transcript a number of their genes and activate heat-shock proteins. These heat-shock proteins participate in the bacteria’s death by causing the bacteria to self-destruct. P. acnes self-destructs in the acne lesion preventing infection and leaving the skin to return to a healthy state. Fortunately, the level of heat required is not sufficient to cause damage to the skin.Tyrell performed numerous lab studies on P. acnes to assess the temperature range in which heat shock response occurs in this bacteria, including a waterbath and a thermal cycler study, known for accuracy to tenths of a degree. The thermal cycler testing was critical in determining if P. acnes’ heat shock response occurs below the point of heat damage of human skin. Futhermore, these tests were critical in assessing the rate of P. acnes death at various temperatures over time (temperature versus time). The results indicated significant death of P. acnes at a temperature well below the thermic damage of human skin.
Clinical Trials of Zeno:
Clinical testing was conducted in both a controlled practitioner setting and a home-use setting to confirm that Zeno is as safe and effective as predicate devices. A total of 51 subjects between the ages of 13 and 70 years old were enrolled and completed clinical study to determine safety and efficacy. This was a randomized, controlled double-blind study. Each subject had two similar acne blemishes selected and the blemishes were randomized to treatment with Zeno or a placebo device. Each blemish received a total of three treatments of 2½ minutes each. Blemishes were assessed by the physician investigator prior to each treatment and again on Day 5. Subjects were given a diary to complete for the assessment of their selected blemishes every morning and evening until resolution or Day 14. Blemishes that were treated with Zeno resolved at a faster rate than those treated with the placebo device. Zeno-treated blemish resolved on the average of 53.7 hours (2.3 days) faster than those treated with the placebo device. Additionally, blemishes treated with Zeno showed improvement approximately 30.8 hours (1.3 days) more quickly than those treated with the placebo device. When results for resolution or improvement are combined, subjects reported that Zeno-treated blemish resolved and resolved or improved significantly faster than their clinically matched placebo-treated blemishes. 90% of the blemishes treated with Zeno achieved resolution or improvement within 24 hours versus 37% of the placebo-treated blemishes. 96% of the blemishes treated with Zeno achieved resolution or improvement within 48 hours versus 63% of the placebo-treated blemishes. 100% of the blemishes treated with Zeno achieved resolution or improvement within 72 hours versus 75% of the placebo-treated blemishes. This data is displayed in Figure 4.A home use study was conducted with 16 subjects between the ages of 12 and 70 that presented with at least one acne blemish. Subjects were not instructed in the use of Zeno and were dispensed a Zeno, the Product Manual and Quick Start Guide to take home and begin self-treating their study blemishes until the blemish(es) resolved or until Day 7, whichever occurred earlier. Subjects were allowed to self-treat additional blemish(es). At the end of the study subjects’ understanding was assessed by completion of a Subject Understanding Survey. In general, all subjects reported a good understanding of the device. All subjects agreed or strongly agreed that they understood the data information panel and the labeled warnings and precautions. All subjects strongly agreed that they were confident that they could use Zeno without supervision by a doctor.
Description of the Device:
Zeno is a portable hand-held device that, through the use of ClearPoint Technology, produces precisely controlled low level sustained heat that is applied to individual acne blemishes via a small biocompatible metal tip. The temperature is continually modulated by a PID (Proportional Integral Derivative) controller chip contained within the unit to a specific temperature range and the 2½ minute treatment time is controlled by an integral digital timer.The principle of operation is based on the above-described fact that the application of heat is toxic to multiple forms of bacteria, including the P. acnes species, which is the underlying cause of the majority of acne and pustular eruptions. The Zeno device has been optimized for appropriate heat and timing characteristics to effectively destroy the P. acnes bacteria with consideration of the heat tolerance of human tissue.
Power is supplied to the Zeno by three (3) rechargeable AAA nickel-metal hydride batteries. The batteries are recharged by plugging the UL-approved wall mounted power supply into a standard 120v household electrical outlet and the other end of the power cord is plugged into the Zeno battery charge port. The batteries are not accessible to the consumer as the batteries are encapsulated in a non conductive case that is not able to be opened by the user.
Zeno is complex in terms of its engineering design and includes multiple fail-safe features:
+ The temperature is continually modulated by a PID controller chip.+ The tip cartridge includes a thermistor to measure the temperature of the treatment tip to within 0.5°F. The treatment tip contains redundant overcurrent protection.
+ The software sounds an “attention” sound and powers off if the treatment tip rises above 130°F or if the heater is in the “on” condition for more than 165 seconds.
+ The battery is protected against over-current by a fuse.
+ The software will not allow more than 10 consecutive treatments in a 30-minute period to prevent customer abuse.
+ Power to the Zeno treatment tip is controlled by two field effect transistors (FET) that are under software control.
Zeno Treatment Tips are produced from a biocompatible anodized aluminum material. Biocompatibility testing was conducted in accordance with ISO 10993 Biological Testing of Medical and Dental Materials and Devices. Zeno Treatment Tips are designed for replacement. Zeno relies on very carefully controlled heat and incorporates several redundant safety mechanisms to ensure that its tight temperature range is maintained. One of the mechanisms is a sensitive thermistor embedded in the treatment tip that provides temperature feedback to prevent overheating. The thermistor and heat producing resistors are embedded in a thermally conductive potting compound inside the biocompatible tip. After multiple cycles of heating and cooling, the integrity of the potting compound (and its thermal contact with the tip) has the potential to break down, reducing the efficiency of its heat transfer. In this condition, it is possible for insufficient heat to be transferred to the user, which could reduce the efficacy of the therapy. Zeno’s Treatment Tips are therefore limited in the number of treatment cycles they allow so as to insure that the thermal efficiency cannot degrade to the point of preventing adequate treatment temperature.