Atralin Gel for the Treatment of Rosacea

• Register: ClinicalTrials.gov
• Last refreshed on: 17 December 2012
• Main ID: NCT01125930
• Date of registration: 13/05/2010
• Primary sponsor: University of Michigan
• Public title: Atralin Gel for the Treatment of Rosacea
• Scientific title: Investigation of the Topical Retinoid, Atralin Gel 0.05% for the Treatment of Erythematotelangiectatic Rosacea
• Date of first enrolment: May 2010
• Target sample size: 81
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01125930
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Lisa E Maier, M.D.
• Affiliation: University of Michigan

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Rosacea

Intervention(s)

Drug: Atralin gel

Drug: vehicle gel

Primary Outcome(s)

Severity of erythematotelangiectatic rosacea signs [Time Frame: 24 weeks]

Severity of erythematotelangiectatic rosacea symptoms [Time Frame: 24 weeks]

Secondary Outcome(s)

Molecular evidence of photodamage [Time Frame: 24 weeks]

Molecular markers of inflammation [Time Frame: 24 weeks]

Photodamage [Time Frame: 24 weeks]

Quality of life [Time Frame: 2, 6, 12, 18, 24 weeks]

Severity of erythematotelangiectatic rosacea symptoms [Time Frame: 2, 6, 12, 18 weeks]

Severity of erythematotelangiectatic signs [Time Frame: 2, 6, 12, 18 weeks]

Signs of other rosacea subtypes [Time Frame: 2, 6, 12, 18 and 24 weeks]

Skin irritation [Time Frame: 2, 6, 12, 18 weeks]

Secondary ID(s)

Derm 616

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Valeant Pharmaceuticals International, Inc.