Atralin Gel for the Treatment of Rosacea
Information source: University of Michigan
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rosacea
Intervention: vehicle gel (Drug); Atralin gel (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University of Michigan Official(s) and/or principal investigator(s):
Lisa E Maier, M.D., Principal Investigator, Affiliation: University of Michigan
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).
Clinical Details
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 signsSeverity of erythematotelangiectatic rosacea symptoms
Secondary outcome: Quality of lifePhotodamage Signs of other rosacea subtypes Molecular markers of inflammation Molecular evidence of photodamage Severity of erythematotelangiectatic signs Severity of erythematotelangiectatic rosacea symptoms Skin irritation
Eligibility
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
Locations and Contacts
University of Michigan Department of Dermatology, Ann Arbor, Michigan 48109, United States; Recruiting
Kathy Keeley, B.S., Phone: 734-936-4075, Email: ktkeeley@med.umich.edu
Jenny Keith, B.A., Phone: 734-936-4075, Email: jennbell@med.umich.edu
Lisa E Maier, M.D., Principal Investigator
Additional Information
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: October 3, 2011
|
