An Early Phase 1 interventional study of Brimonidine Tartrate and Placebo Vehicle Gel in Flushing, Alcohol-Related Disorders and Aldehyde Dehydrogenase Deficiency, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-04.
Sponsored by University of California, San Francisco · Early Phase 1, Interventional, and Treatment
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.
60 studies on the registry are indexed under Flushing; 7 are open to participants now.
This study's enrollment of 20 is below the median of 100 across 52 interventional studies indexed under Flushing.
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Exclusion Criteria:
This is a randomized vehicle controlled, double blinded, interventional study. Patients of East Asian descent with a history of Asian Flushing Syndrome will be asked to apply a thin layer of brimonidine 0.33% gel to one half of their face thirty minutes before consuming alcohol (1.5 oz vodka for women, 3.0 oz vodka for men). The Photos will be taken 30 minutes, one hour, and 1.5 hours after consumption of alcohol. Erythema will be assessed at each time point by both the patient and study investigator using a 5- point erythema assesment score. Patient blood alcohol content (BAC) will be measured noninvasively at each time point.
Drug: Brimonidine Tartrate
This is a randomized vehicle controlled, double blinded, interventional study. Patients of East Asian descent with a history of Asian Flushing Syndrome will be asked to apply a thin layer of vehicle gel to one half of their face thirty minutes before consuming alcohol (1.5 oz vodka for women, 3.0 oz vodka for men). The Photos will be taken 30 minutes, one hour, and 1.5 hours after consumption of alcohol. Erythema will be assessed at each time point by both the patient and study investigator using a 5- point erythema assesment score. Patient blood alcohol content (BAC) will be measured noninvasively at each time point.
Drug: Placebo Vehicle Gel
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.
Also known as: Mirvaso
Vehicle Gel
Clinician Erythema Score
Clinician Erythema Assessment (CEA) Scale Grade 0: Clear skin with no signs of erythema Grade 1: Almost clear of erythema, slight redness Grade 2: Mild erythema, definite redness Grade 3: Moderate erythema, marked redness Grade 4: Severe erythema, fiery redness.
Time frame: Evaluated 30 minutes after alcohol consumption
Patient Erythema Self Assessment
Subject self-assessment 0: No signs of unwanted redness 1. Almost clear of unwanted redness 2. Mild redness 3. Moderate redness 4. Severe redness
Time frame: Evaluated 30 minutes after alcohol consumption
Delayed Clinician Erythema Score
Clinician Erythema Assessment (CEA) Scale
Time frame: Evaluated 60 and 90 minutes after alcohol consumption
Delayed Patient Erythema Self Assessment
Subject self-assessment
Time frame: Evaluated 60 and 90 minutes after alcohol consumption
Plan to share: No
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Brimonidine
University of California, San Francisco →