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

September 23, 2015 updated by: Bitop AG

Non Interventional Study (NIS): Clinical Investigation for Evaluation of the Safety and Efficacy of Ectoin Ear Spray and Normison Ear Spray in Skin Treatment of Outer Ear Canal Irritations: A Mulitcenter Non Interventional Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Elmshorn, Germany
        • HNO Praxis Elmshorn
      • Lueneburg, Germany, 21335
        • HNO Moeller
      • Norderstedt, Germany, 22846
        • HNO Bergmann-Omar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

primary care ENT units study the therapeutic process in this observational trial in total of 60 patients in three centres with dermatological irritations of the outer ear canal and pruritus

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ectoin Ear Spray
treatment according to instruction for use
Device: ear spray
Normison ear spray
treatment according to instruction for use
Device: ear spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pruritus at outer ear canal
Time Frame: 14 days
assessment of the symptoms on visual analogous scale
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of pruritus
Time Frame: 14 days
assessment of the symptom on Visual Analog Score on values between 0 and 10
14 days
Dermatitis
Time Frame: 14 days
assessment of the symptoms of scaly dermatitis on Visual Analog Score on values between 0 and 10
14 days
burning issue on skin
Time Frame: 14 days
assessment of the symptom on Visual Analog Score on values between 0 and 10
14 days
Tolerability
Time Frame: 14 days
assessment on Visual Analog Score on values between 0 and 10
14 days
Efficacy
Time Frame: 14 days
assessment on Visual Analog Score on values between 0 and 10
14 days
Change in number of adverse events
Time Frame: 14 days
incidence of adverse events and correlation to therapy
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bitop AG

Investigators

  • Principal Investigator: Uwe Sonnemann, Dr med, HNO Praxis Elmshorn

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

September 14, 2015

First Submitted That Met QC Criteria

September 23, 2015

First Posted (Estimate)

September 24, 2015

Study Record Updates

Last Update Posted (Estimate)

September 24, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EOS_PPL-084

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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