The study of NPS for back acne is being conducted by Dr. Nestor and Bruce Katz, M.D., clinical professor of dermatology, Icahn School of Medicine at Mount Sinai, and director, Juva Skin & Laser Center, New York. It is comparing the effects of NPS against sham treatment and an untreated control site. It has a planned enrollment of up to 20 patients and follow-up of 90 days posttreatment.
To be eligible for participation, patients must have a minimum of three areas measuring 7x 7 cm of active acne on the back, each containing at least five inflammatory lesions rated moderate to severe. The lesion count must also be similar across the three areas on the back.
NPS energy titration is performed at the baseline visit. One week later, treatment with NPS or sham is applied to one-half of the designated area, and the remaining section is treated on day 21. Patients return for safety and efficacy evaluations at 30, 60 and 90 days thereafter.
Data are available from six patients who each had at least seven to 10 inflammatory lesions within each of the three target sites on the back. The applied energy dose was already titrated down in this first cohort of patients, but across the dose range studied, benefit was noted by 30 days and has been sustained with follow-up reaching up to eight months.
“Our initial data show an 89% lesion reduction in the treated areas,” Dr. Nestor says. “The durability of the responses is expected based on the theory that NPS would be an effective treatment for acne because it destroys the sebaceous gland."
Post-inflammatory hyperpigmentation was the only significant side effect observed so far. The hyperpigmentation resolved over time, was greater in patients with a darker skin type (patients with up to Fitzpatrick skin type 4 are eligible for enrollment), and has been minimized as the energy dose was reduced.