Atralin Gel for the Treatment of Rosacea

Condition(s) targeted: Rosacea

Intervention: vehicle gel (Drug); Atralin gel (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Lisa E. Maier

Official(s) and/or principal investigator(s):
Lisa E Maier, M.D., Principal Investigator, Affiliation: University of Michigan

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).

Official title: Investigation of the Topical Retinoid, Atralin Gel 0.05% for the Treatment of Erythematotelangiectatic Rosacea

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema)

Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia

Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema

Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin

Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing

Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning

Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging

Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product

Secondary outcome:

Quality of Life

Photodamage

Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea

Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea

Signs of Other Rosacea Subtypes: Papulopustular

Molecular Markers of Inflammation

Molecular Evidence of Photodamage

Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness)

Severity of Erythematotelangiectatic Signs: Telangiectasia

Severity of Erythematotelangiectatic Signs: Facial Edema

Severity of Erythematotelangiectatic Signs: Dryness/Irritation

Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing

Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning

Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging

Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment

Skin Irritation Assessed by Facial Stinging Upon Product Application

Skin Irritation Assessed by Facial Itching Upon Product Application

Skin Irritation Assessed by Facial Burning Upon Product Application

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Subjects 18 years of age and older of any race. 2. Clinical diagnosis of mild to moderate erythematotelangiectatic facial rosacea based on physician evaluation. 3. Willing and able to understand and sign informed consent. 4. Able to complete study and comply with study procedures. Exclusion Criteria: 1. Severe self reported facial sensitivity 2. History of allergy to fish 3. Severe sun sensitivity 4. Severe erythematotelangiectatic rosacea requiring systemic treatment 5. Papulopustular, Ocular-only, Phymatous rosacea, Steroid rosacea, pyoderma faciale 6. Unwilling to undergo facial biopsies 7. Concomitant use of medications that are reported to exacerbate rosacea, such as topical and systemic steroids 8. Use of topical rosacea treatments in the past 2 weeks. 9. Use of systemic antibiotics in the past 4 weeks. 10. Use of systemic retinoids within the past 6 months. 11. Use of topical retinoids within the past 3 months 12. Use of laser or light based rosacea treatments within the past 2 months. 13. Cosmetic procedures (e. g., superficial chemical peels, exfoliation or microdermabrasion of the face) within the past two months 14. Use of topical anti-aging medications including alpha hydroxy acids, salicylic acid, beta-hydroxy acid, vitamin A, vitamin E, ascorbic acid 15. Other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments. 16. 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. 17. 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). 18. Subjects who are lactating. 19. Use of any investigational therapy within the past 4 weeks. 20. Known hypersensitivity or previous allergic reaction to retinoids 21. Carcinoid, Pheochromocytoma or other systemic flushing causes

University of Michigan Department of Dermatology, Ann Arbor, Michigan 48109, United States

Related publications:

Pelle MT, Crawford GH, James WD. Rosacea: II. Therapy. J Am Acad Dermatol. 2004 Oct;51(4):499-512; quiz 513-4. Review.

Ertl GA, Levine N, Kligman AM. A comparison of the efficacy of topical tretinoin and low-dose oral isotretinoin in rosacea. Arch Dermatol. 1994 Mar;130(3):319-24.

Vienne MP, Ochando N, Borrel MT, Gall Y, Lauze C, Dupuy P. Retinaldehyde alleviates rosacea. Dermatology. 1999;199 Suppl 1:53-6.

Starting date: May 2010
Last updated: July 15, 2014