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

Phase 1

Conditions: Chronic Otitis Externa
MedDRA version: 8.1Level: LLTClassification code 10031744Term: Other chronic otitis externa

Registration Number: EUCTR2006-004441-42-GB

Lead Sponsor: Southport and Ormskirk Hospital NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To establish the effectiveness of Tacrolimus ointment as a treatment for chronic eczematous otitis externa. This will be evaluated by treatment group comparisons of the patient diary cards, the ENT Specialist’s evaluation and overall assessment.;Secondary Objective: 1. to establish effect of tacrolimus ointment on the skin and microbiological flora of the external auditory canal. This will be evaluated by treatment group comparisons of the microbiological swabs at visit 1 (baseline) and visit 3 (day 14) <br><br>2. to define treatment guidelines of chronic eczematous otitis externa using tacrolimus ointment. <br><br>;Primary end point(s): 1. treatment group comparisons of the patient diary cards and the ENT Specialist’s evaluation and overall assessment<br><br>2. treatment group comparisons of the microbiological swabs at visit 1 (baseline) and visit 3 (day 14)<br>

Secondary Outcome Measures