TerminatedPhase 1/2

Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome Syndrome

Stopped: Lead investigator moved to a new medical center; study was stopped when he left.

United States9 participantsStarted 2008-12

Plain-language summary

Empty Nose Syndrome patients suffer from disabling physical symptoms and considerable distress. To date there is no definitive cure for these symptoms. Established treatment modalities include saline irrigation, surgical implantation of materials or simply use of cotton wads/ silicon cones to simulate the resistive action to airflow of the resected turbinates. This study will research the effectiveness of a new treatment modality in the treatment of Empty Nose Syndrome. This novel treatment method involves the use of botulinum toxin type A (Botox).

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Any patient aged 18-65 years of age presenting with a known diagnosis of ENS who has no known allergies to Botox. Exclusion Criteria: * Patients younger than 18 years or older than 65 years of age. * Patients with neuromuscular disorders or neuropathic diseases. * Patients with infection and or swelling at the site where Botox is to be injected. * Patients with known hypersensitivity to any ingredient in the drug formulation (botulinum toxin, human albumin) * Patients who are or plan to become pregnant within the time period in which the study will be conducted. * Patients who are nursing

What they're measuring

Mean Score of Sino Nasal Outcome Test 22 (SNOT 22)

Timeframe: 2 weeks after intervention, 2 months

Trial details

NCT IDNCT00732680

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-11

Results submitted2013-11-13

View on ClinicalTrials.gov More Empty Nose Syndrome trials