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NCT Number: NCT02558738

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

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.

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Key information

Conditions

Pruritus Dermatitis Ear Diseases Otitis Otitis Externa Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

HNO Praxis Elmshorn, Elmshorn, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ear spray

Device

Primary outcomes

  1. Pruritus at outer ear canal

    Time frame: 14 days

    assessment of the symptoms on visual analogous scale

Secondary outcomes

  1. Severity of pruritus

    Time frame: 14 days

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

  2. Dermatitis

    Time frame: 14 days

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

  3. burning issue on skin

    Time frame: 14 days

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

  4. Tolerability: change in VAS score

    Time frame: 14 days

    assessment of tolerability on the Visual Analogue Score on values between 0 and 10

  5. Efficacy: change in VAS score

    Time frame: 14 days

    assessment of efficacy on Visual Analog Score on values between 0 and 10

  6. Change in number of adverse events

    Time frame: 14 days

    incidence of adverse events and correlation to therapy

Sponsors and collaborators

Lead sponsor

Bitop AG

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 24, 2015
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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