Clinical trial NCT01125930: Atralin Gel for the Treatment of Rosacea
Official title: Investigation of the Topical Retinoid, Atralin Gel 0.05% for the Treatment of Erythematotelangiectatic Rosacea
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Rosacea
Keywords: rosacea
tretinoin
atralin
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Bausch Health Americas, Inc.
First posted: 2010-05-19
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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

Primary outcomes:
measure: Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema)
timeFrame: 24 weeks
measure: Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia
timeFrame: 24 weeks
measure: Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema
timeFrame: 24 weeks
measure: Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin
timeFrame: 24 weeks
measure: Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing
timeFrame: 24 weeks
measure: Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning
timeFrame: 24 weeks
measure: Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging
timeFrame: 24 weeks
measure: Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product
timeFrame: 24 weeks
Secondary outcomes:
measure: Quality of Life
timeFrame: 2, 6, 12, 18, 24 weeks
measure: Photodamage
timeFrame: 24 weeks
measure: Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea
timeFrame: 2, 6, 12, 18 and 24 weeks
measure: Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea
timeFrame: 2, 6, 12, 18 and 24 weeks
measure: Signs of Other Rosacea Subtypes: Papulopustular
timeFrame: 2, 6, 12, 18, 24 weeks
measure: Molecular Markers of Inflammation
timeFrame: 24 weeks
measure: Molecular Evidence of Photodamage
timeFrame: 24 weeks
measure: Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness)
timeFrame: 2, 6, 12, 18 weeks
measure: Severity of Erythematotelangiectatic Signs: Telangiectasia
timeFrame: 2, 6, 12, 18 weeks
measure: Severity of Erythematotelangiectatic Signs: Facial Edema
timeFrame: 2, 6, 12, 18 weeks
measure: Severity of Erythematotelangiectatic Signs: Dryness/Irritation
timeFrame: 2, 6, 12, 18 weeks
measure: Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing
timeFrame: 2, 6, 12, 18 weeks
measure: Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning
timeFrame: 2, 6, 12, 18 weeks
measure: Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging
timeFrame: 2, 6, 12, 18 weeks
measure: Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment
timeFrame: 2, 6, 12, 18 weeks
measure: Skin Irritation Assessed by Facial Stinging Upon Product Application
timeFrame: 2, 6, 12, 18 weeks
measure: Skin Irritation Assessed by Facial Itching Upon Product Application
timeFrame: 2, 6, 12, 18 weeks
measure: Skin Irritation Assessed by Facial Burning Upon Product Application
timeFrame: 2, 6, 12, 18 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Department of Dermatology
state: Michigan
Study officials:
affiliation: University of Michigan
name: Lisa E Maier, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pelle MT, Crawford GH, James WD. Rosacea: II. Therapy. J Am Acad Dermatol. 2004 Oct;51(4):499-512; quiz 513-4. doi: 10.1016/j.jaad.2004.03.033.
citation: 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.
citation: Vienne MP, Ochando N, Borrel MT, Gall Y, Lauze C, Dupuy P. Retinaldehyde alleviates rosacea. Dermatology. 1999;199 Suppl 1:53-6. doi: 10.1159/000051380.