Treatment of Asian Flushing Syndrome With Topical Alpha Agonists

This is an interventional treatment trial for Flushing Read More

Inclusion Criteria:

• Male or female, 21 years of age or older
• Self-reported East Asian descent defined as being at least partially ethnically Han Chinese, Japanese, or Korean.
• No persistent facial erythema at baseline as reported by the patient and observed by investigators at first visit
• Moderate to severe facial erythema (grade of 2 or more on the Clinician Erythema Assessment scale) induced by one standard drink of alcohol as defined by the National Institute on Alcohol Abuse and Alcoholism (12 ounces of beer, 5% alcohol; 5 ounces of wine, 12% alcohol; or 1.5 ounces of distilled spirits, 40% alcohol). Patients must provide a photo of themselves in sufficient lighting after having one standard drink to be confirmed by the investigators at the screening visit.
• Written informed consent for any and all study procedures
• Written authorization for use and release of health and research study information
• Written authorization for use of photos in publications and presentations
• Ability to follow study instructions and complete study assessment tools without assistance.
• Ability to communicate with the study team without the need for translators.
• Female patients of childbearing potential must have a negative urine pregnancy test result at the screening visit.

Exclusion Criteria:

• Age < 21
• Known hypersensitivity or allergies to any component of the study treatment
• Pregnancy or active breastfeeding
• History of rosacea
• Exam findings consistent with rosacea
• Current use of medications for rosacea
• Current use of oral H1 or H2 antagonists, or use in the last 2 weeks
• Active acne vulgaris
• Current use of topical medications for acne vulgaris
• Any uncontrolled systemic disease or abnormal vital signs at study visit
• Current use of medications known to cause cutaneous flushing such as rifampin, nicotinic acid, calcium channel blockers (or other antihypertensives), nitroglycerin, prostaglandins, bromocriptine, tamoxifen, thyroid hormone replacement, cyproterone acetate (or other medications to induce fertility), sildenafil citrate, and monoamine oxidase inhibitors
• Current use of medications known to be contraindicated with alcohol use such as disulfiram, rifampin, isoniazid, isotretinoin, anxiolytics, non-steroidal anti-inflammatory medications, acetaminophen, warfarin, antidepressants, St. John's Wort, cyclobenzaprine and other muscle relaxants, metronidazole, trimethoprim-sulfamethoxazole.
• History of any of the following conditions: Raynaud's syndrome, orthostatic hypotension, cerebral or coronary insufficiency, congenital or acquired heart disease, thromboangiitis obliterans, alcohol or substance abuse, liver fibrosis or cirrhosis, hepatitis, renal insufficiency, severe gastrointestinal bleeding, seizures, or psychiatric disease.
• Protected or vulnerable patient groups such as inmates, children and minors, pregnant women, and individuals with cognitive impairment or those who are legally blind, illiterate, or cannot talk or write.
• Use of any products containing oxymetazoline or brimonidine within 2 weeks of initial study visit.
• Use of topical glucocorticosteroids applied to the face within 2 weeks of initial study visit
• Any prior treatment with lasers, intense pulsed light, photodynamic therapy, or other energy based therapy to the face.
• Facial hair, tattoos, facial characteristics, or cutaneous disease (such as actinic damage, melasma, postinflammatory hyper- or hypopigmentation, excessive telangiectasias, nevi, or other pigmentation) which may interfere with assessments of erythema in the opinion of the investigators.
• Current enrollment in an investigational drug or device study or participation in such within 30 days of entry into this study.
• Any condition or situation that, in the investigator's opinion, may put the patient at significant risk, or may significantly interfere with the patient's participation in the study.