Trial Outcomes & Findings for Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome Syndrome (NCT NCT00732680)

NCT ID: NCT00732680

Last Updated: 2016-04-18

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 9 participants
• Primary outcome timeframe: 2 weeks after intervention, 2 months
• Results posted on: 2016-04-18

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Botulinum Toxin Type A n=9 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks after intervention, 2 months

Population: No study data was collected in the study. The Lead investigator moved to a new medical center; the study was stopped when he left.

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.

Outcome measures

Outcome data not reported

Adverse Events

Botulinum Toxin Type A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rizwan Siwani, MBBS

Mayo Clinic

Phone: 507-284-9155

Email: siwani.rizwan@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place