Pilot Investigation of a Topographical Filter Dermal Patch in Patients with Tinnitus.

OBJECTIVES: A new topographical filter in a dermal administration patch that organizes water molecules has been suggested as an alternative treatment for manifested tinnitus. The aim of this study was to evaluate this patch in a pilot study.

MATERIALS AND METHODS: 12 patients were included (10 completed) in an open study all receiving treatment with daily changed patches. The objectives were to evaluate safety and performance of the patch during and after treatment. The primary objective was to evaluate the tinnitus severity (by Tinnitus Severity Questionnaire, TSQ) and tinnitus annoyance (by Visual Analogue Scale, VAS). The secondary objective was to evaluate if the patch could improve the patient's quality of life (by SF-36 Quality of life questionnaire) and sleep initiation time (self-rated).

RESULTS: At visit 4, after 21 days of treatment, an improvement (decrease in TSQ score) was seen in 5 responder patients, which was sustained at the post-treatment visit. A marginal increase in TSQ score was seen also initially in 5 non-responder patients, 4 of which were responders post-treatment. The rated tinnitus annoyance, quality of life and sleep initiation time did not show significant changes. The safety evaluation did not present any safety concerns.

CONCLUSION: This small pilot study indicates that it can be reasonable to recommend on a risk-benefit and safety perspective treatment with the dermal patch to patients with tinnitus as a consumer product based on the lack of other effective alternative treatment. Further and larger studies, and also proven experience, are recommended for stronger evidence.