Trial Outcomes & Findings for Office-sclerotherapy for Epistaxis Due to Hereditary Hemorrhagic Telangiectasia (NCT NCT01408732)

Last Updated: 2019-11-01

Results Overview

The primary outcome measure will be severity of epistaxis as measured by the Epistaxis Severity Score (ESS). The ESS, a recently developed online questionarrie that calculates the grading system for epistaxis severity. The higher the score the more severe the nose bleeds are Scale consists of several questions with a range of scale from 0-5 The average score is calculated for a final assessment

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

18 participants

Primary outcome timeframe

Change from Baseline to 14 weeks

Results posted on

2019-11-01

Participant Flow

Each group will get the same therapy in a different order Total number of subjects 18 with 2 incompletes. First period is 6 weeks with a 2 week washout period and 2 period is 6 weeks

Participant milestones

Participant milestones
Measure	Sclerotherapy Intervention Then Standard Treatment This group will receive, on the first period of the study, sclerotherapy with STS to any visible lesions in the nose at the outset, followed by any needed standard treatments for breakthrough epistaxis. Washout period of 2 weeks	Standard Treatment Then Sclerotherapy The standard treatment group will continue their pre-study "standard treatment" methods to treat epistaxis on the first 6 weeks of the study, followed by intervention with sclerotherapy on the second 6 weeks of the study, plus any additionally needed standard treatments for breakthrough epistaxis. Wash out period 2 weeks
Overall Study STARTED	9	9
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Sclerotherapy Intervention Then Standard Treatment This group will receive, on the first period of the study, sclerotherapy with STS to any visible lesions in the nose at the outset, followed by any needed standard treatments for breakthrough epistaxis. Washout period of 2 weeks	Standard Treatment Then Sclerotherapy The standard treatment group will continue their pre-study "standard treatment" methods to treat epistaxis on the first 6 weeks of the study, followed by intervention with sclerotherapy on the second 6 weeks of the study, plus any additionally needed standard treatments for breakthrough epistaxis. Wash out period 2 weeks
Overall Study Withdrawal by Subject	2	2

Baseline Characteristics

Office-sclerotherapy for Epistaxis Due to Hereditary Hemorrhagic Telangiectasia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Entire Study Population n=18 Participants
Age, Continuous	51.8 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants
Curacao criteria Visceral Lesions	9 participants n=5 Participants
Curacao criteria Family history:	9 participants n=5 Participants
Number of Telangiectasia	7 Telangiectasia n=5 Participants
Telangiectasia type Type 1	4 participants n=5 Participants
Telangiectasia type Type 2	13 participants n=5 Participants
Telangiectasia type Type 3	1 participants n=5 Participants
Prior Treatment Moisturization	11 participants n=5 Participants
Prior Treatment Packing	4 participants n=5 Participants
Prior Treatment Cautery	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from Baseline to 14 weeks

Outcome measures

Outcome measures
Measure	Sclerotherapy Intervention n=16 Participants This group will receive, on the first period of the study, sclerotherapy with STS to any visible lesions in the nose at the outset, followed by any needed standard treatments for breakthrough epistaxis. On the second period of the study this group will continue with standard treatments that they had been receiving for epistaxis prior to the study. Standard treatment may include nasal packing, cauterization, laser treatments, microdebrider, and septodermoplasty. Sodium tetradecyl sulfate (sotradecol): 3% Sodium tetradecyl sulfate (STS) is mixed with air at a ratio of 4 parts air to 1 part STS for injection into the affected vessels in the nose. Topical anesthetic is applied to the nasal mucosa prior to injections. Once the mixture is ready for injection, the needle is placed into the vessel, in a submucosal fashion, penetrating 1-2 mm, and very small quantities of foam are injected	Standard Treatment n=16 Participants The standard treatment group will continue their pre-study "standard treatment" methods to treat epistaxis on the first period of the study, followed by intervention with sclerotherapy on the second period of the study, plus any additionally needed standard treatments for breakthrough epistaxis. Standard treatment may include nasal packing, cauterization, laser treatments, microdebrider, septodermoplasty, and any other treatments that the patient reports using that are accepted as standard of care. Sodium tetradecyl sulfate (STS) is injected into the nasal lesions as a solution prepared by foaming STS with air at a 4:1 ratio. Individual injection amounts vary between lesions, patients and treatment sessions. No more than a total of 3 ml of solution is used in each session. Multiple lesions can be treated bilaterally, each with a separate injection. Standard Treatment
Severityof Epistaxis	-0.4578 units on a scale Standard Deviation 2.8943	-1.4375 units on a scale Standard Deviation 4.1993

Adverse Events

Sclerotherapy Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Treatment

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

Holly Boyer, MD

University of Minnesota

Phone: 612-725-2000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place