Dermatitis, Otitis Externa, Pruritus
Conditions
Keywords
dermatitis and irritations at the outer ear canal, prevention of subacute otitis externa
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.
Interventions
DEVICEear spray
Sponsors
Bitop AG
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pruritus at outer ear canal | 14 days | assessment of the symptoms on visual analogous scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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: change in VAS score | 14 days | assessment of tolerability on the Visual Analogue Score on values between 0 and 10 |
| Efficacy: change in VAS score | 14 days | assessment of efficacy 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 |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORUwe Sonnemann, Dr med
HNO Praxis Elmshorn
Outcome results
None listed