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NCT03497442 · ClinicalTrials.gov registry record · Early Phase 1
Treatment of Asian Flushing Syndrome With Topical Alpha Agonists
A Early Phase 1 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
NCT03497442: Completed Early Phase 1 study, sponsored by University of California, San Francisco.
NCT03497442 is a Early Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 20 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03497442, a Early Phase 1 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Brimonidine Tartrate
- DRUG Placebo Vehicle Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-07-12 |
| Est. Completion | 2019-03-25 |
| Phase | Early Phase 1 |
What the finished NCT03497442 record still lists
NCT03497442 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Brimonidine Tartrate is the first listed.
NCT03497442 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03497442 about?
NCT03497442 is a clinical study titled "Treatment of Asian Flushing Syndrome With Topical Alpha Agonists". 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, a...
What is the current status of trial NCT03497442?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2018-07-12. Estimated completion is 2019-03-25.
What interventions are being tested in trial NCT03497442?
The interventions under investigation include: Brimonidine Tartrate (DRUG), Placebo Vehicle Gel (DRUG).
Who is sponsoring clinical trial NCT03497442?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03497442's enrollment target sits among peer trials
20 1157th of 2000 higher than 710 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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