CompletedPhase 2

Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations

United States57 participantsStarted 2016-10

Plain-language summary

A Phase II randomized trial will be initiated to evaluate closure of the perforated tympanic membrane as the primary measureable outcome. The goal is to determine the safety and efficacy of Fibroblast Growth Factor-2 (FGF-2) in the closure of chronic tympanic membrane perforations (TMP). If FGF-2 is topically applied for the treatment of chronic TMP in humans, it is hypothesized it will be safe, tolerable and effective for use as treatment for tympanic membrane perforation. A total of 60 subjects will be recruited.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Dry tympanic membrane perforation of greater than 3 months duration
✓. If female, post-menopausal or sterile, or if she is of child-bearing potential, must have a negative beta-human chorionic gonadotropin (HCG) test and must be using an adequate form of birth control such as birth control pills, birth control implants, intrauterine devices (IUDs), diaphragms or condoms.

What they're measuring

Number of Patients With Tympanic Membrane Closure Following Treatment

Timeframe: ~60 days

Trial details

NCT IDNCT02307916

SponsorD. Bradley Welling, MD, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-07

Results submitted2020-04-22

View on ClinicalTrials.gov More Tympanic Membrane Perforation trials