Clinical trial: Combination Therapy for the Treatment of Rosacea (NCT00945373)

Eligibility criteria:
Inclusion Criteria:

          1. Must understand and voluntarily sign an informed consent form.

          2. Must be male or female and aged ≥ 18 years at time of consent.

          3. Must be able to adhere to the study visit schedule and other protocol requirements.

          4. Must have clinically typical confirmed diagnosis of erythematotelangestatic rosacea.

          5. Females of childbearing potential (FCBP)‡ must have one negative urine pregnancy tests
             at screening. In addition, sexually active FCBP must agree to use TWO of the following
             adequate forms of contraception while on study medication: oral, injectable, or
             implantable hormonal contraceptives; tubal ligation; intrauterine device; barrier
             contraceptive with spermicide; or vasectomized partner while on the study. A FCBP must
             agree to have pregnancy tests every 4 weeks while on study medication.

          6. Males (including those who have had a vasectomy) must agree to use barrier
             contraception (latex condoms) when engaging in sexual activity with FCBP while on
             study medication.

        Exclusion Criteria:

          1. Inability to provide voluntary informed consent.

          2. Pregnant or breastfeeding female.

          3. A skin examination reveals the presence of another skin disease and/or condition
             (excessive facial hair, excessive scarring, sunburn, or other disfigurement) located
             on the face that would confound the evaluation of the rosacea.

          4. Current or past ocular rosacea, such as conjunctivitis, iritis and keratitis of
             sufficient severity to require topical or systemic antibiotics.

          5. Subjects with recurrent gastritis, renal dysfunction or ulcer disease (peptic or
             duodenal).

          6. Treatment with topical antibiotics, topical steroids, topical retinoids and other
             topical rosacea treatments on the face within 14 days of baseline and throughout the
             study.

          7. Treatment with any systemic medication or therapy known to affect inflammatory
             responses within the 30 days prior to baseline and throughout the study.

          8. Treatment with systemic retinoids within 6 months prior to study entry (e.g.,
             acitretin, isotretinoin).

          9. Use of laser or light based rosacea treatments within the past 2 months.

         10. History of hypersensitivity or allergies to any ingredient in the study drug.

         11. Current drug or alcohol abuse.

         12. Have participated in any clinical trial involving an investigational drug or cosmetic
             product or procedure within the past 30 days.
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? Entailment