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

Completed

• Conditions: Pruritus; Dermatitis; Otitis Externa
• Interventions: Device: ear spray

• Registration Number: NCT02558738
• Lead Sponsor: Bitop AG

Brief Summary

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

Not available

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2015-08
• Status Verified: 2015-09
• Study Completion: 2015-09
• Study First Submitted: 2015-09-14
• Study First Submitted QC: 2015-09-23
• Last Update Submitted: 2015-09-23
• Study First Posted: 2015-09-24
• Last Update Posted: 2015-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normison ear spray	ear spray	treatment according to instruction for use
Ectoin Ear Spray	ear spray	treatment according to instruction for use

Primary Outcome Measures

Name	Time	Method
Pruritus at outer ear canal	14 days	assessment of the symptoms on visual analogous scale

Secondary Outcome Measures

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

Trial Locations

Locations (3)

HNO Bergmann-Omar; 🇩🇪 Norderstedt, Germany

HNO Moeller; 🇩🇪 Lueneburg, Germany

HNO Praxis Elmshorn; 🇩🇪 Elmshorn, Germany