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

• Status: Terminated
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

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