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

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.

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Key information

Conditions

Acute Otitis Externa

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hagakliniken, Gothenburg, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DPK-060

Drug

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.

Placebo for DPK-060 ear drops

Drug

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.

Primary outcomes

Adverse Events (AEs)

Time frame: 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".

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.

Sponsors and collaborators

Lead sponsor

DermaGen AB

Industry

Collaborators

Pergamum AB

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Oct 5, 2011
Registry last updated: Dec 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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