Clinical trial: Study to Evaluate the Efficacy and Safety of PAC-14028 Cream in Rosacea Patients (NCT02052999)

Eligibility criteria:
Inclusion Criteria:

          -  Male and female patients at the age of 20 to 65 years old

          -  Clinical diagnosis of erythematotelangiectatic or papulopustular rosacea according to
             National Rosacea Committee Expert Society with

               -  Erythema severity ≥ 1

               -  Telangiectasia severity ≥ 1

               -  At least 3 papules or pustules in facial region

          -  IGA score ≥ 2

          -  Voluntarily signed written informed consent forms for study participation

        Exclusion Criteria:

          -  Patients who are unable to be diagnosed or evaluated for rosacea due to tattoo or scar
             in the facial area

          -  Patients who are unable to be diagnosed or evaluated for rosacea due to excess
             hair(e.g., mustache, beard, whiskers etc.) in the facial area

          -  Patients who are sensitive to the drug or vehicle

          -  Previous administration of oral retinoid or vitamin A(≥10,000 units/day) within 6
             months prior to visit 1

          -  Previous use of estrogen or oral contraceptives within 3 months prior to visit 1

          -  Previous use of topical retinoids or oral antibiotics (e.g., tetracycline,
             tetracycline derivatives, erythromycin, erythromycin derivatives, sulfamethoxazole,
             trimethoprim) or oral steroid for the treatment of facial rosacea within 1 month prior
             to visit 1

          -  Previous use of topical steroid or topical antibiotics, topical treatment for
             rosacea(e.g., metronidazole, azelaic acid) within 2 weeks prior to visit 1

          -  Presently undergoing anti-coagulant therapies

          -  History of hematologic disease

          -  Ocular-only, Phymatous rosacea, or papulopustular rosacea patients who require
             systemic antibiotics

          -  History of laser treatment for rosacea within 6 weeks prior to visit 1

          -  Alcoholic or drug abuse patients

          -  Patients who are treated with prohibited concomitant drugs or considered to inevitably
             require treatment with prohibited concomitant drugs during the study period

          -  Renal function impairment with creatinine level higher than twice of maximum normal
             range

          -  Hepatic function impairment with AST/ALT higher than twice of maximum normal range

          -  Pregnant and lactating woman, woman with child-birth potential(should have negative
             pregnancy test at the baseline visit of the study)

          -  Participation in another clinical study within 1 month prior to screening

          -  Patients considered ineligible for study participation by the principal investigator
             or sub-investigator for other reasons; rosacea due to other medical (liver disease,
             renal failure, etc.), psychotic, or neuropathic causes rather than as a skin disease
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 65 Years

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? 1