A Study of DPK-060 to Investigate Clinical Safety and Efficacy in Patients With Acute External Otitis

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate safety and tolerability of DPK-060 2% ear drops compared to placebo for DPK-060 ear drops in patients with acute external otitis. The secondary objectives are to evaluate clinical cure and microbiological growth following treatment with DPK-060 2% ear drops compared to placebo for DPK-060 ear drops.

Official Title
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A Randomised, Parallel-group, Double-blind, Placebo-controlled Study of DPK-060 to Investigate Clinical Safety and Efficacy in Patients With Acute External Otitis

Conditions
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Acute Otitis Externa

Intervention / Treatment
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* Drug: DPK-060
* Drug: Placebo for DPK-060 ear drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A clinical diagnosis of acute external otitis of a severity degree not requiring specialist care Age 12 years and older Exclusion Criteria: Known or suspected perforation of the tympanic membrane A clinical diagnosis of chronic suppurative otitis media, acute otitis media, acute otorrhea or malignant otitis externa Local ear canal abnormalities Congenital abnormalities of the external auditory canal or obstructive bony exostosis Mastoiditis or suppurative non-infectious ear disorders (e.g. cholesteatoma) Malignant tumour of the external auditory canal History of otologic surgery (except for surgery confined to the temporomandibular joint) Seborrheic dermatitis or other dermatological conditions of the external auditory canal that would complicate evaluation Current or prior use (within 7 days) of ear washes using alcohol, vinegar or other astringents Any clinically relevant past or present infectious/viral disease Current infection requiring systemic antimicrobial therapy Current or prior use of systemic (within 14 days) or topical (within 7 days) antibiotics Current or prior use of systemic (within 30 days) or topical (within 7 days) steroids History of immune dysfunction/deficiency and immunosuppressive therapy Diabetes mellitus

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DPK-060 2% ear drops<br>DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable). | Drug: DPK-060<br>* DPK-060 2% ear drops were administered as 3 applications per day into the outer ear by use of a single-dose pipette (0.3 mL/pipette) for 7 days. In case clinical symptoms remained after 7 days of treatment, the treatment period was extended by another 3 days with 3 applications per day.<br>|
| Placebo Comparator: Placebo for DPK-060 ear drops<br>Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable). | Drug: Placebo for DPK-060 ear drops<br>* Placebo for DPK-060 ear drops were administered as 3 applications per day into the outer ear by use of a single-dose pipette (0.3 mL/pipette) for 7 days. In case clinical symptoms remained after 7 days of treatment, the treatment period was extended by another 3 days with 3 applications per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (AEs) | AEs were collected by a non-leading question such as have you experienced any new health problems or worsening of existing conditions as well as reporting events directly observed or spontaneously volunteered by patients. All AEs including but not limited to events reported by the patient, or reported in answer to an open question by the Investigator or member of the study team were recorded as an AE including the following information: Diagnosis; Start date (and time, if relevant), Stop date (and time, if relevant) or resolution; Severity; Action taken; Causality; Seriousness; Outcome. | AEs occurring during the treatment period were collected on day 8 or 11, as applicable. Four weeks after the last dose of investigational medicinal product (IMP), previously reported AEs were followed up and assessed as recovered or not recovered. |