Status:
COMPLETED
A Study of DPK-060 to Investigate Clinical Safety and Efficacy in Patients With Acute External Otitis
Lead Sponsor:
DermaGen AB
Collaborating Sponsors:
Pergamum AB
Conditions:
Acute Otitis Externa
Eligibility:
All Genders
12+ years
Phase:
PHASE2
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 objec...
Eligibility Criteria
Inclusion
- A clinical diagnosis of acute external otitis of a severity degree not requiring specialist care
- Age 12 years and older
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT01447017
Start Date
November 1 2011
End Date
November 1 2012
Last Update
December 10 2013
Active Locations (7)
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1
Hagakliniken
Gothenburg, Sweden
2
Me3+ Clinical Trials
Gothenburg, Sweden
3
Hallands Sjukhus
Halmstad, Sweden, 30185
4
ProbarE
Lund, Sweden