A Randomised, Parallel-group, Double-blind, Placebo-controlled Study of DPK-060 to Investigate Clinical Safety and Efficacy in Patients With Acute External Otitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- DermaGen AB
- 入组人数
- 69
- 试验地点
- 7
- 主要终点
- Adverse Events (AEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of acute external otitis of a severity degree not requiring specialist care
- •Age 12 years and older
排除标准
- •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
研究组 & 干预措施
DPK-060 2% ear drops
DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
干预措施: DPK-060 (Drug)
Placebo for DPK-060 ear drops
Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
干预措施: Placebo for DPK-060 ear drops (Drug)
结局指标
主要结局
Adverse Events (AEs)
时间窗: AEs occurring during the treatment period were collected on day 8 or 11, as applicable. Four weeks after the last dose of investigational medicinal product (IMP), previously reported AEs were followed up and assessed as "recovered" or "not recovered".
AEs were collected by a non-leading question such as "have you experienced any new health problems or worsening of existing conditions" as well as reporting events directly observed or spontaneously volunteered by patients. All AEs including but not limited to events reported by the patient, or reported in answer to an open question by the Investigator or member of the study team were recorded as an AE including the following information: Diagnosis; Start date (and time, if relevant), Stop date (and time, if relevant) or resolution; Severity; Action taken; Causality; Seriousness; Outcome.
次要结局
未报告次要终点