PruritusNCT02558738
Non Interventional Clinical Investigation of Ectoin Ear Spray in Skin Treatment of Outer Ear Canal Irritations
An observational study of Pruritus and Dermatitis, run by Bitop AG at 3 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pruritus, Dermatitis, Otitis Externa
- What is being tested?
- ear spray
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 3 sitesGermany
- Study dates
- 22 Jun 2015to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- according to instructions for use
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
HNO Praxis Elmshorn
Elmshorn
HNO Moeller
Lüneburg, 21335
HNO Bergmann-Omar
Norderstedt, 22846
About this study
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
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.
- Conditions
- Pruritus, Dermatitis, Otitis Externa
- Being tested
- ear spray
- Keywords
- dermatitis and irritations at the outer ear canal, prevention of subacute otitis externa
- Medical subject headings
- Pruritus, Dermatitis, Otitis Externa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ear sprayDevice
| Study group | Role | What they receive |
|---|---|---|
| Ectoin Ear Spray | treatment according to instruction for use Receives: Device: ear spray | |
| Normison ear spray | treatment according to instruction for use Receives: Device: ear spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pruritus at outer ear canal
assessment of the symptoms on visual analogous scale
Measured: 14 days
Secondary outcomes (6)
Severity of pruritus
assessment of the symptom on Visual Analog Score on values between 0 and 10
Measured: 14 days
Dermatitis
assessment of the symptoms of scaly dermatitis on Visual Analog Score on values between 0 and 10
Measured: 14 days
burning issue on skin
assessment of the symptom on Visual Analog Score on values between 0 and 10
Measured: 14 days
Tolerability: change in VAS score
assessment of tolerability on the Visual Analogue Score on values between 0 and 10
Measured: 14 days
Efficacy: change in VAS score
assessment of efficacy on Visual Analog Score on values between 0 and 10
Measured: 14 days
Change in number of adverse events
incidence of adverse events and correlation to therapy
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study start22 Jun 2015
- Primary completion14 Aug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitop AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Uwe Sonnemann, Dr med, Principal investigator, HNO Praxis Elmshorn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558738
- Sponsor's protocol ID
- EOS_PPL-084
- Status last verified
- Jan 2026
- First submitted
- 14 Sep 2015
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02558738
- Acronym / sponsor ID
- EOS_PPL-084
- Conditions
- Pruritus, Dermatitis, Otitis Externa
- Keywords
- dermatitis and irritations at the outer ear canal, prevention of subacute otitis externa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bitop AGIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2015 (actual)
- Primary completion
- 14 Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ectoin Ear Spray | – | Device: ear spraytreatment according to instruction for use |
| Normison ear spray | – | Device: ear spraytreatment according to instruction for use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- according to instructions for use
Key exclusion criteria (6 listed)
- otitis media, acute otitis media
- acute otitis externa
- earache
- perforation of the ear-drum (membrana tympani)
- infections at the ear
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ear spray | Device | Ectoin Ear Spray, Normison ear spray |
Primary outcome
Pruritus at outer ear canal
Time frame: 14 days
assessment of the symptoms on visual analogous scale
6 secondary outcomes
Severity of pruritus
Time frame: 14 days
Dermatitis
Time frame: 14 days
burning issue on skin
Time frame: 14 days
Tolerability: change in VAS score
Time frame: 14 days
Efficacy: change in VAS score
Time frame: 14 days
Change in number of adverse events
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uwe Sonnemann, Dr med principal investigator
HNO Praxis Elmshorn
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pruritus and Dermatitis, run by Bitop AG at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pruritus at outer ear canal (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.