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

Pruritus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02558738
• Other study ID #: EOS_PPL-084
• Status: Completed
• Phase: N/A
• First received: September 14, 2015
• Last updated: September 23, 2015
• Start date: June 2015
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Bitop AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dermatitis
• Otitis Externa
• Pruritus

Intervention

Device:
• ear spray

Locations

Country	Name	City	State
Germany	HNO Praxis Elmshorn	Elmshorn
Germany	HNO Moeller	Lueneburg
Germany	HNO Bergmann-Omar	Norderstedt

Sponsors (1)

Lead Sponsor	Collaborator
Bitop AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pruritus at outer ear canal	assessment of the symptoms on visual analogous scale	14 days	Yes
Secondary	Severity of pruritus	assessment of the symptom on Visual Analog Score on values between 0 and 10	14 days	Yes
Secondary	Dermatitis	assessment of the symptoms of scaly dermatitis on Visual Analog Score on values between 0 and 10	14 days	Yes
Secondary	burning issue on skin	assessment of the symptom on Visual Analog Score on values between 0 and 10	14 days	Yes
Secondary	Tolerability	assessment on Visual Analog Score on values between 0 and 10	14 days	Yes
Secondary	Efficacy	assessment on Visual Analog Score on values between 0 and 10	14 days	Yes
Secondary	Change in number of adverse events	incidence of adverse events and correlation to therapy	14 days	Yes