Atralin Gel for the Treatment of Rosacea
Condition: Rosacea
MeSH terms: Rosacea
Intervention: vehicle gel; Atralin gel
Intervention description: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.; Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Intervention MeSH terms: Tretinoin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: rosacea; tretinoin; atralin

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