Overview

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

Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
DermaGen AB
Collaborator:
Pergamum AB
Treatments:
Carbamide Peroxide
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