NCT04139018

Timolol Gel for Epistaxis in Hereditary Hemorrhagic Telangiectasia

Efficacy of a Timolol Gel in the Care for Epistaxis in Patients With Hereditary Hemorrhagic Telangiectasia: A Double-Blinded, Randomized Controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study is a double-blinded, randomized controlled trial to evaluate the efficacy of an intranasal topical timolol gel in the care for epistaxis in adults with hereditary hemorrhagic telangiectasia.

Detailed description

This study is a double-blinded, placebo-controlled, 8-week randomized clinical trial investigating the efficacy of timolol gel in the management of epistaxis in adults with HHT. The Specific Aims are to determine in adults with HHT-associated epistaxis: 1. If topical timolol gel is more effective than placebo in reducing the frequency and severity of epistaxis. 2. If topical timolol gel is more effective than placebo in improving hemoglobin levels. 3. The frequency of adverse events, side effects, and safety profile of topical timolol gel delivered to the nasal mucosa.

Conditions

• Hereditary Hemorrhagic Telangiectasia

Interventions

Type	Name	Description
DRUG	Timolol Gel	Timolol nasal gel 0.1% will be prepared with a poloxamer gel (combination of poloxamer 188 and 407; pH adjusted to 4.5-6.5) and 0.5 ml applied to each nostril twice daily. The total daily dose would amount to 2 mg.
DRUG	Placebo Gel	Placebo gel is prepared with poloxamers and no active ingredients.

Timeline

• Start date: 2019-10-20
• Primary completion: 2020-05-20
• Completion: 2020-05-20
• First posted: 2019-10-25
• Last updated: 2021-08-24
• Results posted: 2021-08-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study