Clinical trial: A Study to Determine Safety and Efficacy of B244 in Subjects With Mild to Moderate Rosacea (NCT03590366)

Eligibility criteria:
Inclusion Criteria:

          1. Male and female subjects ≥18.

          2. A clinical diagnosis of mild to moderate facial rosacea.

          3. In good general health as determined by a thorough medical history, physical
             examination, clinical chemistry and hematology.

          4. Presence of 3 to 20 inflammatory lesions on the face (i.e. papules/pustules).

          5. A Clinician Erythema Assessment (CEA) score of 2-3 at Screening and at Baseline Visits
             (prior to the investigational product application).

          6. Mild to Moderate IGA score of 2-3 at Screening and at Baseline Visits (prior to the
             investigational product application).

          7. Willing to refrain from using any topical or systemic treatments for the treatment of
             rosacea, other than the investigational product.

          8. Females of childbearing potential with a negative urine pregnancy test (UPT) at
             Screening and Baseline/Day 1 (prior to the investigational product application).

          9. Ability to comprehend and comply with study procedures.

         10. Agree to commit to participate in the current protocol.

         11. Provide written informed consent prior to any study procedure being performed.

        Exclusion Criteria:

          1. Female subjects who are pregnant, lactating or who are trying to conceive will be
             excluded from participation in this study.

          2. Any uncontrolled chronic or serious disease or medical condition that would normally
             prevent participation in a clinical trial, or, in the judgment of the Investigator,
             would put the subject at undue risk, or might confound the study assessments (e.g.,
             other dermatological diseases), or might interfere with the subject's participation in
             the study, (e.g., planned hospitalization during the study).

          3. Particular forms of rosacea (e.g., rosacea conglobata, rosacea fulminans, isolated
             rhinophyma, isolated pustulosis of the chin, Ocular rosacea Phymatous rosacea,
             Steroid-induced rosacea, severe rosacea including pyoderma faciale) or other
             concomitant facial dermatoses that are similar to rosacea such as peri-oral
             dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute
             lupus erythematosus, or actinic telangiectasia.

          4. Presence of more than two (2) nodulocystic lesions on the face.

          5. Presence of less than 3 and more than 20 inflammatory lesions on the face (i.e.
             papules/pustules).

          6. Severe papulopustular rosacea requiring systemic treatment.

          7. Participation at the time of eligibility assessment (Screening) in any other
             investigational drug or device study or may have participated within 30 days prior to
             Screening.

          8. Commencement of new hormonal therapy or dose change to hormonal therapy within 30 days
             prior to baseline. Dose and frequency of use of any hormonal therapy started more than
             30 days prior to baseline must remain unchanged throughout the study. Hormonal
             therapies include, but are not limited to, oral, injected or implanted hormonal
             methods of contraception or placement of an intrauterine device (IUD) or intrauterine
             system (IUS) or other forms of hormonal contraception that have comparable efficacy
             (e.g. vaginal ring or transdermal hormone contraception)

          9. Presence of beard or excessive facial hair at Screening which would interfere with the
             study treatments or study assessments and refusal to remove for duration of study.

         10. Carcinoid, Pheochromocytoma or other systemic causes of flushing.

         11. Known sensitivity to B244 or its components.

         12. Refusal to submit to blood and urine sampling for laboratory analysis.

         13. Treatment with prohibited medications.
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? 1