The Akloma Tinnitus Patch in Patients With Manifested Tinnitus (Aktin)

[Tinnitus Talk]

Tinnitus Talk submitted a new resource:

The Akloma Tinnitus Patch in Patients With Manifested Tinnitus (Aktin) (version 1.0) - Investigation of the antinitus patch in patients with manifested tinnitus.

OBJECTIVES:
Primary Objective The primary objective will be a decrease of inconvenience with at least 10% for at least 50% of the subjects.
Secondary Objectives
The secondary objective will be to:
To evaluate if the patch can improve the tinnitus patient's quality of life and sleep quality.
METHODOLOGY
Study Design:
An open safety and performance clinical investigation of the antinitus patch in patients with manifested tinnitus.
Treatment Duration:
1 patch per day for 3 weeks
Primary Endpoint:...

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[RaZaH]

Is this for real ? What is going on here ?

 

[Beste]

Any update to this?

 

[lapidus]

Any update to this?

Read the thread about Antinitus in the alternative treatments and research section:
https://www.tinnitustalk.com/threads/antinitus-tinnitus-patch-—-does-it-work.758/

 

[Seanie n]

I've tried this and it didn't work for me, my tinnitus was noise-induced, one night out on the town too many times, also I have a TMJ-related issue just to complicate things even more.

 

[Frédéric]

In order to update this thread and to give a conclusion to this clinical trial, I found these links:

At the company website:
https://www.antinitus.com/tinnitus-patch-antinitus-international-tinnitus-journal/

The results released in June 2017:
http://www.tinnitusjournal.com/arti...r-dermal-patch-in-patients-with-tinnitus.html

Pilot Investigation of a Topographical Filter Dermal Patch in Patients with Tinnitus
Authors: Peter Ahnblad

PDF

Abstract
Objective: 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.

Keywords: tinnitus, transdermal patch, consumer product safety

 

[Frédéric]

I forgot to recall the reference of the clinical trial:
https://clinicaltrials.gov/ct2/show/NCT01226108
Status: completed (of course).