Phase 2 N=69 Randomized Quadruple-blind Treatment

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

Acute Otitis Externa

Bottom Line

View on ClinicalTrials.gov: NCT01447017 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2013

Primary outcome: Primary: Adverse Events (AEs) — 10; 3; 6; 1 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: DPK-060 (Drug); Placebo for DPK-060 ear drops (Drug)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: DermaGen AB
Primary completion: Oct 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Adverse Events (AEs)	10; 3; 6; 1; 0; 0	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01447017). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.