An observational study in Pruritus, Dermatitis and Otitis Externa, sponsored by Bitop AG. Completed at 3 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by Bitop AG · Observational
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.
490 studies on the registry are indexed under Pruritus; 93 are open to participants now.
This study's enrollment of 60 is below the median of 128 across 48 observational studies indexed under Pruritus.
Browse Pruritus studies →Bitop AG is the lead sponsor of 26 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
treatment according to instruction for use
Device: ear spray
treatment according to instruction for use
Device: ear spray
Pruritus at outer ear canal
assessment of the symptoms on visual analogous scale
Time frame: 14 days
Severity of pruritus
assessment of the symptom on Visual Analog Score on values between 0 and 10
Time frame: 14 days
Dermatitis
assessment of the symptoms of scaly dermatitis on Visual Analog Score on values between 0 and 10
Time frame: 14 days
burning issue on skin
assessment of the symptom on Visual Analog Score on values between 0 and 10
Time frame: 14 days
Tolerability: change in VAS score
assessment of tolerability on the Visual Analogue Score on values between 0 and 10
Time frame: 14 days
Efficacy: change in VAS score
assessment of efficacy on Visual Analog Score on values between 0 and 10
Time frame: 14 days
Change in number of adverse events
incidence of adverse events and correlation to therapy
Time frame: 14 days
Ran from Jun 2015 to primary completion in Aug 2015, 1 month.
Of 21 observational studies under Pruritus, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 35. This study's 1 month is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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