Oculus Innovative Sciences, a US-based developer of wound care devices, has completed a 112-day patient follow-up in a double-blinded, comparative and randomised clinical study of its Microcyn Technology-based hydrogel for the management of hypertrophic or keloid scars.
The trial, which was based on an FDA-approved protocol, had enrolled 40 patients from four US clinical sites, including Albuquerque, High Point, Austin and College Station.
The primary endpoint of the study was to compare the hydrogel with a dimethicone comparator using the Vancouver Scar Scale, which measures vascularity, height / thickness, pliability and pigmentation of scars.
Measurements of pain, itch and other reported adverse events, as well as treatment satisfaction as reported by patients through a questionnaire, were the secondary endpoints.
The trial reported no direct product-related serious adverse events in either arm during the study.
The company expects to complete data analysis and thereafter submit the 510(k) application to the FDA for review within the next 60 to 90 days.
After completion of FDA’s review, the company expects to release the data immediately.
Oculus Innovative Sciences CEO Jim Schutz said; "We remain optimistic about achieving our intended results and upon FDA clearance, anticipate that our US dermatology partner, AmDerma / Quinnova, will launch later in 2013."
At the time of the FDA 510k clearance, the company’s US dermatology partner AmDerma / Quinnova will reimburse Oculus for the cost of the trial and launch the hydrogel later in 2013.