NCT03497442

Treatment of Asian Flushing Syndrome With Topical Alpha Agonists

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

Asian Flushing Syndrome (AFS) is a genetic disease affecting approximately 70% of patients of East Asian descent characterized by severe flushing with minimal ethanol consumption. This reaction is cosmetically unattractive and socially limiting. Many Asian patients avoid drinking alcohol on dates, at weddings, and during business events because of this reaction and the perception of being drunk or alcoholic. Ethanol is normally metabolized to acetic acid by two enzymes. The first enzyme, alcohol dehydrogenase (ADH) converts ethanol to acetaldehyde. The second enzyme, aldehyde dehydrogenase 2 (ALDH2) converts the toxic acetaldehyde to harmless acetic acid. When ADH function is increased or ALDH2 function is decreased, the toxic intermediate acetaldehyde accumulates resulting in cutaneous flushing. Over 70% of East Asians have genetic polymorphisms in either ADH or ALDH2 leading to intense flushing with ethanol consumption. There are no effective topical treatments for the Asian Flushing Syndrome. Oral antihistamines have been used with some success in treating symptoms of Asian Flushing Syndrome; however these can have sedating effects and may be dangerous in combination with alcohol. Brimonidine is a selective α2-adrenoceptor agonist that acts through vasoconstriction and is commercially available in a topical gel. This topical treatment is FDA approved for the indication of facial flushing and has a long history of safety in human subjects.

Conditions

• Flushing
• Alcohol-Related Disorders
• Aldehyde Dehydrogenase Deficiency

Interventions

Type	Name	Description
DRUG	Brimonidine Tartrate	Topical brimonidine tartrate will be applied to one half of each participant's face. A randomization process will be used to determine which side of the face each participant will apply treatment to. The untreated side of the face will receive a placebo vehicle. Patient and clinician will be blinded to treatment side.
DRUG	Placebo Vehicle Gel	Vehicle Gel

Timeline

• Start date: 2018-07-12
• Primary completion: 2019-03-25
• Completion: 2019-03-25
• First posted: 2018-04-13
• Last updated: 2020-05-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study