FDA Approves Scar Treatment
U.S. launch expected in first half of 2014 (December 4)
The FDA has approved Microcyn Scar Management HydroGel (Oculus Innovative Sciences) for the management of old and new hypertrophic and keloid scarring resulting from burns, general surgical procedures, and trauma wounds. The treatment is to be administered under the supervision of a health care professional.
A double-blind, randomized clinical study was conducted to demonstrate the equivalency of Microcyn HydroGel to a predicate device in scar management. The 40-patient study was conducted at four U.S. sites over 16 weeks, ending in March 2013. Qualified scars included linear or widespread hypertrophic or keloid scars. The age of target scars ranged from 3 months to 1 year. Investigators evaluated qualified scars using the Vancouver Scar Scale (VSS), which assesses scar vascularity, height/thickness, pliability, and pigmentation. In addition, pain and itch symptoms were evaluated by the subjects.
The VSS total score was calculated for each subject and visit as the sum of the scores reported for each of three items (vascularity, pliability, and height). The VSS total score ranged from 0 to 9. Individual signs and symptoms were summarized by treatment group. The count and percent of subjects in each category were presented for the VSS items of vascularity, pliability, and height, and for the subject assessment of scar symptoms for pain and itch.
In both the Microcyn HydroGel and the active-control groups, the VSS total score improved consistently at each of the visits. At day 56, the mean VSS total score improvement from baseline was –2.10 in the Microcyn group compared with –1.28 in the control group. Similarly, at day 112, the mean VSS total score improvements were –2.70 in the Microcyn group and –1.83 in the control group. While both groups improved, the reductions were greater in the Microcyn group.
Source: Oculus Innovative Sciences; December 4, 2013.