A study to evaluate the role of tacrolimus ointment (Protopic®) 0.1% in the treatment of chronic otitis externa.

Southport and Ormskirk Hospital NHS Trust0 个研究点开始时间: 2006年12月21日最近更新: 2017年8月21日

适应症

试验速览

暂无简介。

•1.Male or female patient, aged 18 or older, regardless of race.
•2.Patient has been diagnosed with bilateral chronic eczematous otitis externa and has received standard treatment at the ENT clinic for 6 months without having achieved satisfactory clinical control of the condition.
•3.Women of child bearing potential must use an acceptable method of birth control prior and have a negative urine pregnancy test prior to study entry.
•4.Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
•5.Subjects should not receive vaccinations during the study or 14 days before or after the study. In case of live attenuated vaccination, this period should be extended to 28 days before or after the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1.Patient is less than 18 years of age.
•2.Patient is allergic or intolerant to macrolide antibiotics, tacrolimus, and/or its excipients.
•3.Patient with malignancy or history of malignancy except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
•4.Subjects currently receiving immunosuppressive drugs.
•5.Patient is participating or has participated in another investigational drug trial or is receiving or has received an investigational drug within the last 28 days before entry into this study.
•6.Patient has been previously enrolled in this study.
•7.Patient is unlikely to comply with the visits scheduled in the protocol.
•8.Patient has any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may invalidate communication with the investigator
•9.Patient is pregnant or a breast-feeding mother.

发起方

Southport and Ormskirk Hospital NHS Trust