NCT02558738

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2015

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 22, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2015

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

September 14, 2015

Last Update Submit

January 28, 2026

Conditions

PruritusDermatitisOtitis Externa

Keywords

dermatitis and irritations at the outer ear canalprevention of subacute otitis externa

Outcome Measures

Primary Outcomes (1)

  • Pruritus at outer ear canal

    assessment of the symptoms on visual analogous scale

    14 days

Secondary Outcomes (6)

  • Severity of pruritus

    14 days

  • Dermatitis

    14 days

  • burning issue on skin

    14 days

  • Tolerability: change in VAS score

    14 days

  • Efficacy: change in VAS score

    14 days

  • +1 more secondary outcomes

Study Arms (2)

Ectoin Ear Spray

treatment according to instruction for use

Device: ear spray

Normison ear spray

treatment according to instruction for use

Device: ear spray

Interventions

ear sprayDEVICE
Ectoin Ear SprayNormison ear spray

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care ENT units study the therapeutic process in this observational trial in total of 60 patients in three centres with dermatological irritations of the outer ear canal and pruritus

You may qualify if:

  • according to instructions for use

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

HNO Praxis Elmshorn

Elmshorn, Germany

Location

HNO Moeller

Lüneburg, 21335, Germany

Location

HNO Bergmann-Omar

Norderstedt, 22846, Germany

Location

MeSH Terms

Conditions

PruritusDermatitisOtitis Externa

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOtitisEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Uwe Sonnemann, Dr med

    HNO Praxis Elmshorn

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2015

First Posted

September 24, 2015

Study Start

June 22, 2015

Primary Completion

August 14, 2015

Study Completion

September 1, 2015

Last Updated

January 30, 2026

Record last verified: 2026-01

Locations

DE(3)