A Randomised, Double-Blind, Vehicle-Controlled Study of the Safety and Tolerability of BTX 1702 in Patients with Papulopustular Rosacea

INTERVENTION: BTX 1702 10% (w/w) Gel or BTX 1702 20% (w/w) Gel will be applied twice daily (BID) for 56 days. All patients will have 1.5mL of study medication applied BID to the entire face. No escalation of dose will occur. All patients will be required to maintain a daily dosing diary documenting each application of the study medication. Patients will return the study medication bottles within the medication kit at each visit so that the unblinded study site staff can weigh study medication kits to ensure patient compliance with dosing. CONDITION: Papulopustular Rosacea; ; Papulopustular Rosacea Skin ‐ Dermatological conditions PRIMARY OUTCOME: Changes in clinical labs including the composite of complete blood count (CBC), chemistry, and urinalysis[At Baseline and again at Day 57 post intervention] Cutaneous tolerability (a composite of erythema, scaling, dryness, pruritis, and burning/stinging) to be assessed by the PI or trained designee using a Cutaneous Tolerability Assessment scale.[Baseline to Days 15, 29 (pre and post‐dose) and post intervention at EOS Visit on Day 57] Reported adverse events (AEs) including treatment‐emergent adverse events (TEAE)[Baseline to Days 15, 29 (pre and post dose), and post intervention at EOS Visit on Day 57] SECONDARY OUTCOME: Absolute change in inflammatory lesion counts as conducted by a clinician/investigator[Baseline to Days 15, 29 (pre dose) and post intervention at the EOS Visit on Day 57] Blood samples to assess the plasma levels of study medication[Pre‐dose at Baseline and Days 15, 29 and post intervention on Day 57 (selected sites only)] Change in Clinician’s Erythema Assessment (CEA) scale[Baseline to Days 15 and 29 (pre dose) and post intervention at the EOS Visit on Day 57] Change in Investigator’s Global Assessment (IGA‐PP) [Baseline to Day 29 (pre dose) and post intervention at the EOS Visit on Day 57] Change to Patient Reported Outcomes (PRO) with respect to their rosacea symptoms[57 days post enrolment] Percent change in inflammatory lesion counts as conducted by a clinician/investigator[Baseline to Days 15, 29 (pre dose) and post intervention at the EOS Visit on Day 57] INCLUSION CRITERIA: #1. Patient has a diagnosis at Screening and Baseline of moderate or severe papulopustular rosacea of the face with: a. 15 to 75 (inclusive) inflammatory lesions (papules/pustules) on the face. b. Rosacea severity of moderate (3) or severe (4) on a 5‐point static investigator global assessment for papules & pustules (IGA‐PP) c. CEA score of 3 or 4 (moderate or severe) assessed on the face. d. No more than 5 large open comedones. #2. An independent reviewer will review screening photographs to confirm eligibility of the patient for enrolment. No patient may be randomized prior to the confirmation of eligibility by the independent reviewer. #3. Patient has less than or equal to 2 nodular lesions (greater than or equal to 5 mm in diameter). #4. Patient agrees to abstain from use of marijuana or cannabidiol (CBD) products throughout the study. #5. Male patients and their partners must agree and commit to use a barr