A Study of DPK-060 to Investigate Clinical Safety and Efficacy in Patients With Acute External Otitis
Condition: Acute Otitis Externa
MeSH terms: Otitis; Otitis Externa
Intervention: DPK-060; Placebo for DPK-060 ear drops
Intervention description: 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.
Intervention MeSH terms: Carbamide Peroxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 69.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

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