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    Novel acne gel found safe in three clinical trials

     

    The first of the three studies was conducted in 18 adults with moderate to severe acne, for which the gel was applied twice daily for 5 days. The placebo-controlled trial found no evidence of detectable systemic exposure and there were no changes in systemic nitrate levels from pretreatment or between the vehicle and active treated.

    “We used nitrate as a marker for nitric oxide exposure,” Dr. Stasko says. “The active gel had a similar level of nitrate as the placebo.”

    The second safety study recruited 18 adolescents with acne, for which the gel was applied only once daily for 21 days. Like the first study, the non-placebo controlled trial showed no detectable exposure to the drug’s active ingredient and that nitrate exposure on day 1 was not substantially different from day 21.

    The third study assessed cardiovascular safety. Consisting of 48 adults with acne, the trial tested both a therapeutic dose of 4% concentration and a much higher dose of 12% concentration. There was also a placebo and positive control (moxifloxacin, which is known to induce minor cardiovascular changes).

    All four arms of the study applied treatment only once, and patients were monitored at several intervals over the first 24 hours.

    “Our gel had no effect on any of the cardiovascular parameters at either concentration,” Dr. Stasko says. “There was also no difference, again, in systemic nitrate levels that float throughout the body, in any of the treatment groups.”

    The prescription-only acne gel, in a once-daily formulation at a planned 4% concentration, is expected to become commercially available in 2019. The gel could also represent Novan’s first product to market and the first ever nitric oxide-based drug to be approved for dermatology.

    “Unlike some current acne products, SB204 has shown really good cutaneous tolerability, is non-irritating, and does not require application twice a day,” Dr. Stasko says.

    The company plans to position the gel as first-line therapy for mild to moderate acne, that could also be included as part of a regimen of existing first-line treatments.

    Disclosure: Dr. Stasko is co-founder, president and CEO of Novan Inc.

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