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Trial record 23 of 24 for:    Ectoine

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02558738
Recruitment Status : Completed
First Posted : September 24, 2015
Last Update Posted : September 24, 2015
Sponsor:
Information provided by (Responsible Party):
Bitop AG

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
Pruritus Dermatitis Otitis Externa Device: ear spray

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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 : June 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching
Drug Information available for: Temazepam

Group/Cohort 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



Primary Outcome Measures :
  1. Pruritus at outer ear canal [ Time Frame: 14 days ]
    assessment of the symptoms on visual analogous scale


Secondary Outcome Measures :
  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 [ Time Frame: 14 days ]
    assessment on Visual Analog Score on values between 0 and 10

  5. Efficacy [ Time Frame: 14 days ]
    assessment 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558738


Locations
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Germany
HNO Praxis Elmshorn
Elmshorn, Germany
HNO Moeller
Lueneburg, Germany, 21335
HNO Bergmann-Omar
Norderstedt, Germany, 22846
Sponsors and Collaborators
Bitop AG
Investigators
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Principal Investigator: Uwe Sonnemann, Dr med HNO Praxis Elmshorn

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Responsible Party: Bitop AG
ClinicalTrials.gov Identifier: NCT02558738     History of Changes
Other Study ID Numbers: EOS_PPL-084
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: September 24, 2015
Last Verified: September 2015
Keywords provided by Bitop AG:
dermatitis and irritations at the outer ear canal
prevention of subacute otitis externa
Additional relevant MeSH terms:
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Otitis
Otitis Externa
Dermatitis
Pruritus
Skin Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Skin Manifestations
Signs and Symptoms
Temazepam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action