Clinical Results
Clinical testing was conducted in both a controlled practitioner setting and a home-use setting to confirm that Zeno™ treatment is as safe and effective as predicate devices. The subjects were enrolled and completed a 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 for 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 blemishes 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 were combined, subjects reported that Zeno-treated blemishes resolved or improved significantly faster than their clinically matched 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.

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 blemish(es) 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 labelled warnings and precautions. All subjects strongly agreed that they were confident that they could use Zeno without supervision by a doctor.