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

March 18, 2016 updated by: Mayo Clinic

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.

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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, plastipore cartilage grafts etc.) We will investigate a new method of treatment for ENS. This will involve injection of botulinum toxin 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 botulinum toxin type A in improving overall quality of life in ENS patients.

Methods:

ENS patients in this study will receive botulinum toxin type A along with adjunctive treatment which will include several measures. First of all, patients will be given a nasal rinse bottle and will be instructed to irrigate their noses twice a day as follows:

  • Irrigate the nose 250cc (about 125cc each side) to clear the mucus.
  • Stop and gently clear the nose.
  • Irrigate the nose 250cc (about 125cc each side) once again.
  • Sit quietly for 10 minutes. No blowing.
  • Do not blow the nose for 2 hours.

Patients will be asked to use sesame oil once a day to prevent drying of the nasal mucosa with further administration as needed. In addition they will advised to make certain lifestyle modifications that will include sleeping with a cool mist humidifier, drinking plenty of fluids and engaging in regular physical activity.

Before and after treatment data will be obtained in the form of a breathing test and patient questionnaires that will measure changes in physical and mental health.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55904
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Botulinum Toxin Type A
Treatment will be in the form of 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
Drug: Botulinum Toxin Type A
10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
Other Names:
  • Botox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Score of Sino Nasal Outcome Test 22 (SNOT 22)
Time Frame: 2 weeks after intervention, 2 months
The SNOT 22 is a validated measure of health related quality of life in sinonasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0-110 and lower scores represent better health related quality of life.
2 weeks after intervention, 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

August 8, 2008

First Submitted That Met QC Criteria

August 11, 2008

First Posted (Estimate)

August 12, 2008

Study Record Updates

Last Update Posted (Estimate)

April 18, 2016

Last Update Submitted That Met QC Criteria

March 18, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-005015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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