Title
A Study of DPK-060 to Investigate Clinical Safety and Efficacy in Patients With Acute External Otitis
A Randomised, Parallel-group, Double-blind, Placebo-controlled Study of DPK-060 to Investigate Clinical Safety and Efficacy in Patients With Acute External Otitis
Phase
Phase 2Lead Sponsor
DermaGen ABStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Acute Otitis ExternaIntervention/Treatment
dpk-060 ...Study Participants
69The 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.
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 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.
DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
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
| Event Type | Organ System | Event Term | DPK-060 2% Ear Drops | Placebo for DPK-060 Ear Drops |
|---|
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.
