NCT02558738
Completed
Not Applicable
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
Interventionsear spray
Overview
- Phase
- Not Applicable
- Intervention
- ear spray
- Conditions
- Pruritus
- Sponsor
- Bitop AG
- Enrollment
- 60
- Locations
- 4
- Primary Endpoint
- Pruritus at outer ear canal
- Status
- Completed
- Last Updated
- 3 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •according to instructions for use
Exclusion Criteria
- •otitis media, acute otitis media
- •acute otitis externa
- •perforation of the ear-drum (membrana tympani)
- •infections at the ear
- •systemic corticosteroid treatment or local at the ear
Arms & Interventions
Ectoin Ear Spray
treatment according to instruction for use
Intervention: ear spray
Normison ear spray
treatment according to instruction for use
Intervention: ear spray
Outcomes
Primary Outcomes
Pruritus at outer ear canal
Time Frame: 14 days
assessment of the symptoms on visual analogous scale
Secondary Outcomes
- Severity of pruritus(14 days)
- Dermatitis(14 days)
- burning issue on skin(14 days)
- Tolerability(14 days)
- Efficacy(14 days)
- Change in number of adverse events(14 days)
- Tolerability: change in VAS score(14 days)
- Efficacy: change in VAS score(14 days)
Study Sites (4)
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