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NCT03497442
Treatment of Asian Flushing Syndrome With Topical Alpha Agonists
EARLY_PHASE1 trial testing Brimonidine Tartrate in Flushing in 20 participants. Completed in 25 March 2019.
25 March 2019
Quick facts
| Lead sponsor | University of California, San Francisco |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 12 July 2018 |
| Primary completion | 25 March 2019 |
| Estimated completion | 25 March 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Brimonidine Tartrate (BRIMONIDINE TARTRATE) — full drug profile →
- Placebo Vehicle Gel
Conditions studied
- Flushing — all drugs for Flushing →
- Alcohol-Related Disorders — all drugs for Alcohol-Related Disorders →
- Aldehyde Dehydrogenase Deficiency — all drugs for Aldehyde Dehydrogenase Deficiency →
Sponsor
University of California, San Francisco
Who can join
21 and older, any sex, with Flushing or Alcohol-Related Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Effect of Topical Brimonidine on Alcohol-Induced Flushing in Asian Individuals: A Randomized Clinical Trial.
Yu WY, Lu B, Tan D, Aroyan C, et al · · 2020 · cited 6× · PMID 31799996 · DOI 10.1001/jamadermatol.2019.3508
Verify or expand the search:
- PubMed search for NCT03497442
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT03785340 — Study of Brimonidine Tartrate Nanoemulsion Eye Drop Solution in the Treatment of Dry Eye Disease (DED) · Phase 3 · completed
- NCT03173365 — The Effect of Topical Brimonidine Tartrate on Hand-foot Syndrome (HFS) in Cancer Patients · Phase 2 · terminated
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03497442 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of California, San Francisco
- Last refreshed: 4 May 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03497442.
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