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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2015

Interventions

  • Device: ear spray

Arms, Groups and Cohorts

  • Ectoin Ear Spray
    • treatment according to instruction for use
  • Normison ear spray
    • treatment according to instruction for use

Clinical Trial Outcome Measures

Primary Measures

  • Pruritus at outer ear canal
    • Time Frame: 14 days
    • assessment of the symptoms on visual analogous scale

Secondary Measures

  • Severity of pruritus
    • Time Frame: 14 days
    • assessment of the symptom on Visual Analog Score on values between 0 and 10
  • Dermatitis
    • Time Frame: 14 days
    • assessment of the symptoms of scaly dermatitis on Visual Analog Score on values between 0 and 10
  • burning issue on skin
    • Time Frame: 14 days
    • assessment of the symptom on Visual Analog Score on values between 0 and 10
  • Tolerability
    • Time Frame: 14 days
    • assessment on Visual Analog Score on values between 0 and 10
  • Efficacy
    • Time Frame: 14 days
    • assessment on Visual Analog Score on values between 0 and 10
  • Change in number of adverse events
    • Time Frame: 14 days
    • incidence of adverse events and correlation to therapy

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bitop AG
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Uwe Sonnemann, Dr med, Principal Investigator, HNO Praxis Elmshorn

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