A Study to Determine Safety and Efficacy of B244 in Subjects With Mild to Moderate Rosacea
Condition: Rosacea
MeSH terms: Rosacea
Intervention: B244; Vehicle
Intervention description: B244 Suspension; Vehicle suspension
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization will be 1:1 so that equal numbers of patients will be treated in each arm of the study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: This is a double blind study. Participants will be assigned to study treatment in accordance with the randomization schedule generated for the allocation of vehicle or B244 prior to the initiation of the trial. Randomization will be centrally-based and performed using an appropriate IWRS (an automated randomization system).
Each participant scheduled to receive investigational product (IP) will receive a randomization number at the time of randomization. The randomization number will be used to identify the study medication kit assigned to the participant and indicate the treatment to be administered to that participant.
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Type 1 erythematotelangiectatic rosacea

Summary:

      This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II
      trial, comparing the effect of twice daily B244 application for 8 weeks vs. vehicle
      application on treatment of mild to moderate rosacea.
    

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.