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

• Sponsor: Bitop AG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02558738
• Collaborator: (none)
• Enrollment: 60
• Locations: 3
• Duration (Months): 3
• Patients Per Site: 20
• Patients Per Site Per Month: 6.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pruritus; Dermatitis; Otitis Externa	Device: ear spray

Study Design

• Study Type: Observational
• Actual Enrollment: 60 participants
• Observational Model: Case-Crossover
• Time Perspective: Prospective
• 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
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Pruritus at outer ear canal [14 days]

   assessment of the symptoms on visual analogous scale

Secondary Outcome Measures

1. Severity of pruritus [14 days]

   assessment of the symptom on Visual Analog Score on values between 0 and 10

2. Dermatitis [14 days]

   assessment of the symptoms of scaly dermatitis on Visual Analog Score on values between 0 and 10

3. burning issue on skin [14 days]

   assessment of the symptom on Visual Analog Score on values between 0 and 10

4. Tolerability [14 days]

   assessment on Visual Analog Score on values between 0 and 10

5. Efficacy [14 days]

   assessment on Visual Analog Score on values between 0 and 10

6. Change in number of adverse events [14 days]

   incidence of adverse events and correlation to therapy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HNO Praxis Elmshorn	Elmshorn		Germany
2	HNO Moeller	Lueneburg		Germany	21335
3	HNO Bergmann-Omar	Norderstedt		Germany	22846

Sponsors and Collaborators

• Bitop AG

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bitop AG
• ClinicalTrials.gov Identifier: NCT02558738
• Other Study ID Numbers: EOS_PPL-084
• First Posted: Sep 24, 2015
• Last Update Posted: Sep 24, 2015
• Last Verified: Sep 1, 2015

• Keywords provided by Bitop AG: dermatitis and irritations at the outer ear canal; prevention of subacute otitis externa
• Additional relevant MeSH terms: Otitis; Otitis Externa; Dermatitis; Pruritus

Study Results

No Results Posted as of Sep 24, 2015