Clinical trial: Atralin Gel for the Treatment of Rosacea (NCT01125930)

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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21.

Patient description (patient's own words): I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21.

Does the patient match the trial criteria? Contradiction