A Limited Pilot Interventional Uncontrolled Study
1 August, 2010 / Written by Antinitus
A limited, interventional, uncontrolled pilot study on the safety and efficiency of the Antinitus® patch.
The study was, as commissioned by Antinitus AB, carried out by Karolinska Trial Alliance, a clinical research centre aimed at enabling and conducting clinical studies within the Stockholm County Council (Stockholms Läns Landsting). Karolinska Trial Alliance belongs to Karolinska University Hospital, one of Europe’s largest hospitals.
Twelve subjects with chronic tinnitus were included in the clinical investigation of which 10 completed the study. All subjects received active Antinitus treatment. A reduction of the tinnitus severity was achieved by 50%, (5/10) at end of the 3-week treatment period and by 90%, (9/10) at a follow-up assessment 4 weeks after the end of therapy.
One subject withdrew due to increased tinnitus and a skin reaction after 6 days of treatment. A likely contributing factor to the skin reaction was the use of acetone for cleaning the skin when replacing the patch. One patient withdrew due to increased tinnitus after 4 days of treatment. The tinnitus severity decreased within one day after ceasing the therapy.
Almost 2 years after the study a post market follow-up was conducted. A written post market form was sent to the 10 patients treated in the study, 9 out of 10 patients reported back. 4/9 of the treated patients recommend the treatment to other patients with tinnitus. 3/9 of the treated patients reported a sustainable relief of their tinnitus.
|Published in The International Tinnitus Journal|