Non Interventional Clinical Investigation of Ectoin Ear Spray in Skin Treatment of Outer Ear Canal Irritations

NCT ID: NCT02558738

Last Updated: 2025-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-22

Study Completion Date

2015-09-30

Brief Summary

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In this observational study, insights regarding the tolerability and influence on the quality of life of the topical treatment with Ectoin Ear Spray compared to Normison ear spray shall be gained under real life conditions in patients with chronic eczematous irritations and pruritus of the outer ear canal.

Detailed Description

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Conditions

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Pruritus Dermatitis Otitis Externa

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Ectoin Ear Spray

treatment according to instruction for use

ear spray

Intervention Type DEVICE

Normison ear spray

treatment according to instruction for use

ear spray

Intervention Type DEVICE

Interventions

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ear spray

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* according to instructions for use

Exclusion Criteria

* otitis media, acute otitis media
* acute otitis externa
* earache
* perforation of the ear-drum (membrana tympani)
* infections at the ear
* systemic corticosteroid treatment or local at the ear
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bitop AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Uwe Sonnemann, Dr med

Role: PRINCIPAL_INVESTIGATOR

HNO Praxis Elmshorn

Locations

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HNO Praxis Elmshorn

Elmshorn, , Germany

Site Status

HNO Moeller

Lüneburg, , Germany

Site Status

HNO Bergmann-Omar

Norderstedt, , Germany

Site Status

Countries

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Germany

Other Identifiers

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EOS_PPL-084

Identifier Type: -

Identifier Source: org_study_id

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