Acute Otitis Externa
Conditions
Brief summary
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.
Interventions
DRUGDPK-060
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.
DRUGPlacebo for DPK-060 ear drops
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.
Sponsors
Pergamum AB
DermaGen AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AEs) | 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. |
Countries
Sweden
Participant flow
Recruitment details
Male and female patients, aged 12 years and above, with a clinical diagnosis of acute external otitis of a severity that is normally treated by primary care were included in the study. The first patient entered the study on January 2012 and the last patient completed the study on November 2012
Participants by arm
| Arm | Count |
|---|---|
| DPK-060 2% Ear Drops DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable). | 45 |
| Placebo for DPK-060 Ear Drops Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable). | 24 |
| Total | 69 |
Baseline characteristics
| Characteristic | DPK-060 2% Ear Drops | Placebo for DPK-060 Ear Drops | Total |
|---|---|---|---|
| Age Continuous | 55.0 years STANDARD_DEVIATION 16.8 | 58.1 years STANDARD_DEVIATION 12.3 | 56.2 years STANDARD_DEVIATION 15.3 |
| Gender Female | 26 participants | 13 participants | 39 participants |
| Gender Male | 14 participants | 11 participants | 25 participants |
| Region of Enrollment Sweden | 45 participants | 24 participants | 69 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 42 | 2 / 24 |
| serious Total, serious adverse events | 0 / 42 | 0 / 24 |
Outcome results
Primary
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.
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.
Population: All safety analyses were performed on safety analysis set. All randomised patients who received at least 1 dose of the IMP and had at least 1 safety follow-up performed were included in the safety analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DPK-060 2% Ear Drops | Adverse Events (AEs) | Number patients with at least one AE | 10 participants |
| DPK-060 2% Ear Drops | Adverse Events (AEs) | Number of patients with at least one related AE | 6 participants |
| DPK-060 2% Ear Drops | Adverse Events (AEs) | Number patients with at least one SAE | 0 participants |
| DPK-060 2% Ear Drops | Adverse Events (AEs) | Number of patients who withdrew due to AE | 1 participants |
| Placebo for DPK-060 Ear Drops | Adverse Events (AEs) | Number of patients who withdrew due to AE | 0 participants |
| Placebo for DPK-060 Ear Drops | Adverse Events (AEs) | Number patients with at least one AE | 3 participants |
| Placebo for DPK-060 Ear Drops | Adverse Events (AEs) | Number patients with at least one SAE | 0 participants |
| Placebo for DPK-060 Ear Drops | Adverse Events (AEs) | Number of patients with at least one related AE | 1 participants |