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Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome Syndrome
This study is currently recruiting participants.
Study NCT00732680   Information provided by Mayo Clinic
First Received: August 8, 2008   Last Updated: June 5, 2009   History of Changes

August 8, 2008
June 5, 2009
December 2008
October 2009   (final data collection date for primary outcome measure)
The endpoints will include the patient questionnaire scores 2 months post-intervention (Snot 22 score, SF36, and IES R scores) and rhinomanometry measurements. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
The endpoints will include the patient questionnaire scores 2 months post-intervention (Snot 22 score, BDI-2 score) and rhinomanometry measurements. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00732680 on ClinicalTrials.gov Archive Site
 
 
 
Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome Syndrome
Prospective Case Series Evaluating Short and Long Term Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome

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.

With this study, we will determine the effectiveness of a new treatment modality in the treatment of Empty Nose Syndrome. This novel treatment method involves the use of Botox.

Background:

Empty Nose Syndrome (ENS) is the term used to describe the condition resulting from over resection of nasal turbinate. Symptoms include depression, dysosmia, bleeding, discharge, crusting, dryness, dysosmia, and pain.

Treatment modalities include adjunctive comfort measures (primarily irrigation), mechanical measures (Silicon cones, cotton wads) and surgical treatment (alloderm implants, plasti-pore cartilage grafts etc.) We will investigate a new method of treatment for ENS. This will involve injection of Botox Type A into the dilator nasalis muscle thus collapsing the internal nasal valve to provide added resistance to air flow.

Objective:

To evaluate effectiveness of Botox in improving overall QoL in patients.

Methods:

42 subjects will undergo treatment with Botox and adjunctive measures that will involve the use of saline irrigation alongwith sesame oil amongst other measures.

Before and after treatment data will be obtained in the form of a breathing test and patient questionnaires that will help us measure changes in physical and mental health (using the sinonasal outcome test questionnaire or SNOT 22, the short form health survey 36 item questionnaire, and the Impact of events revised scale).

Conclusion:

We anticipate that Botox application in ENS patients improve overall QoL in these subjects.

 
Interventional
Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
  • Empty Nose Syndrome
  • Atrophic Rhinitis
Drug: Botox
Experimental: Treatment will be in the form of 10 Units of Botox type A injected into the dilator nasalis muscle on each side of the nose along with adjunctive measures used in the control phase.
Moore EJ, Kern EB. Atrophic rhinitis: a review of 242 cases. Am J Rhinol. 2001 Nov-Dec;15(6):355-61. Review.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
42
December 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Nicole Tombers 507-538-1392 tombers.nicole@mayo.edu
Contact: Ahmed Younes, MD 507-538-1392 younes.ahmed@mayo.edu
United States
 
NCT00732680
Oren Friedman M.D., Mayo Clinic
08-005015
Mayo Clinic
 
Principal Investigator: Oren Friedman, M.D. Mayo Clinic
Mayo Clinic
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP