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

DermaGen

Status and phase: Completed; Phase 2

Conditions: Acute Otitis Externa

Treatments: Drug: Placebo for DPK-060 ear drops; Drug: DPK-060

Study type: Interventional

Funder types: Industry

Identifiers

NCT01447017

2011-004356-20 (EudraCT Number)

DCS-002

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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69 participants in 2 patient groups, including a placebo group

DPK-060 2% ear drops

Experimental group

Description:

DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).

Treatment:

Drug: DPK-060

Placebo for DPK-060 ear drops

Placebo Comparator group

Description:

Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).

Treatment:

Drug: Placebo for DPK-060 ear drops