Chronic Otitis Externa MedDRA version: 8.1 Level: LLT Classification code 10031744 Term: Other chronic otitis externa
Conditions
Interventions
Trade Name: Protopic
Product Name: Protopic
Pharmaceutical Form: Ointment
INN or Proposed INN: TACROLIMUS
CAS Number: 104987113
Current Sponsor code: UK-06-RG-63
Concentration unit: % percent
Concent
Sponsors
Southport and Ormskirk Hospital NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) 2. to define treatment guidelines of chronic eczematous otitis externa using tacrolimus ointment. ;Primary end point(s): 1. treatment group comparisons of the patient diary cards and the ENT Specialist’s evaluation and overall assessment 2. treatment group comparisons of the microbiological swabs at visit 1 (baseline) and visit 3 (day 14) | — |
Countries
United Kingdom
Outcome results
None listed