Atralin Gel for the Treatment of Rosacea

Stopped early · Phase 3

Conditions studied: Rosacea

In brief

Erythematotelangiectatic rosacea is a type of rosacea that causes a red face often with frequent flushing, topical sensitivity and prominent blood vessels. We think that long term damage to skin from the sun (photodamage) may play a role in causing this type of rosacea. Tretinoin is a topical medication that is known to improve photodamage. We want to find out if Atralin (tretinoin 0.05%) Gel used for up to 46 weeks will improve erythematotelangiectatic rosacea (ETR).

Key facts

Study ID

NCT01125930

Run by

Lisa E. Maier

People needed

68

Starts

2010-05-01

Expected to finish

2013-01-01

Last updated by the study team

2014-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects 18 years of age and older of any race.
• Clinical diagnosis of mild to moderate erythematotelangiectatic facial rosacea based on physician evaluation.
• Willing and able to understand and sign informed consent.
• Able to complete study and comply with study procedures.

You may not qualify if…

• Severe self reported facial sensitivity
• History of allergy to fish
• Severe sun sensitivity
• Severe erythematotelangiectatic rosacea requiring systemic treatment
• Papulopustular, Ocular-only, Phymatous rosacea, Steroid rosacea, pyoderma faciale
• Unwilling to undergo facial biopsies
• Concomitant use of medications that are reported to exacerbate rosacea, such as topical and systemic steroids
• Use of topical rosacea treatments in the past 2 weeks.
• Use of systemic antibiotics in the past 4 weeks.
• Use of systemic retinoids within the past 6 months.
• Use of topical retinoids within the past 3 months
• Use of laser or light based rosacea treatments within the past 2 months.
• Cosmetic procedures (e.g., superficial chemical peels, exfoliation or microdermabrasion of the face) within the past two months
• Use of topical anti-aging medications including alpha hydroxy acids, salicylic acid, beta-hydroxy acid, vitamin A, vitamin E, ascorbic acid
• Other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments.
• Clinically significant abnormal findings or conditions (other than rosacea), which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
• If female, Subjects who are either of non-child bearing potential (defined as postmenopausal -absence of menstrual bleeding for 1 year - or as having undergone bilateral tubal ligation, hysterectomy or bilateral ovariectomy) or, if of childbearing potential, Subjects who have had a negative urine pregnancy test at the beginning of the study, and have agreed to practice appropriate birth-control to prevent pregnancy during the study.(The type and dose of birth control must have been stable for at least 2 months prior to study entry and not be expected to change during the study).
• Subjects who are lactating.
• Use of any investigational therapy within the past 4 weeks.
• Known hypersensitivity or previous allergic reaction to retinoids
• Carcinoid, Pheochromocytoma or other systemic flushing causes

Where it is running

• University of Michigan Department of Dermatology — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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