A Randomised, Double-Blind, Vehicle-Controlled Study of the Safety and Tolerability of BTX 1702 in Patients with Papulopustular Rosacea
Botanix Pharmaceuticals Ltd
120 participants
Jul 1, 2021
Interventional
Conditions
Summary
Botanix is developing BTX 1702 for the topical treatment of moderate to severe papulopustular rosacea. This is a randomised, double-blind, vehicle-controlled, parallel-group, Phase 1b study in adult patients, aged 18-65 with moderate or severe papulopustular rosacea. The objective of this study is to determine the safety and tolerability of BTX 1702 10% (w/w) Gel and BTX 1702 20% (w/w) Gel in patients with papulopustular rosacea. Eligible patients will be enrolled and randomised 1:1:1 to BID treatment with BTX 1702 10% (w/w) Gel, BTX 1702 20% (w/w) Gel, or Vehicle Gel for a planned 56 days. Approximately one hundred and twenty (120) patients (80 active: 40 vehicle) will be enrolled. The primary outcome for the study is to determine the safety and tolerability of BTX 1702 10% (w/w) Gel, BTX 1702 20% (w/w) Gel, or BTX 1702 Vehicle Gel following 56 days BID applications in patients with papulopustular rosacea. The safety and tolerability outcome measures will be assessed through the collection and review of AE's, laboratory parameters evaluated throughout the duration of the trial and via information recorded in participant diaries. Exploratory analysis will be conducted via change in inflammatory lesion counts, change in Investigator’s Global Assessment (IGA-PP), change in Clinician’s Erythema Assessment (CEA) scale and Patient Reported Outcomes (PRO).
Eligibility
Inclusion Criteria11
- #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 barrier method of
- contraception throughout the study and for 90 days after last study medication application.
Exclusion Criteria23
- #1. Patient has used any marijuana products, via any route, within 4 weeks prior to the
- Screening Visit. A positive urine drug screen (UDS) for tetrahydrocannabinol (THC) will
- exclude the patient. Patient may be deemed eligible if the UDS identifies patient-reported, prescribed medications or appropriate levels of alcohol, as determined by the investigator.
- #2. Patient has any significant active infection at Baseline.
- #3. Patient has known human immunodeficiency viruses (HIV) infection or hepatitis B or C.
- #4. Patient has initiated a hormonal method contraception within 3 months of Baseline or plans to discontinue or change during the study or changed product within 3 months of Baseline.
- #5. Patient has used topical acne or rosacea treatments, including metronidazole, azaleic acid, sulfacetamide, salicylic acid, benzyl peroxide, ivermectin, bromonidine, or oxymetazoline within 4 weeks of Baseline.
- #6. Patient has used systemic retinoids or high dose (less than 10,000 IU/day) Vitamin A, within 90 days of Baseline.
- #7. Patient has used topical or systemic antibiotics within 4 weeks of Baseline.
- #8. Patient has used topical (facial) or systemic anti-inflammatories for more than 14
- consecutive days in the 4 weeks prior to Baseline.
- #9. Patient has used topical (facial) or systemic corticosteroids 4 weeks prior to Baseline.
- #10. Patient has used vasodilating agents (e.g., anti-hypertensives, erectile dysfunction
- medications, nitroglycerin) 6 weeks prior to Baseline.
- #11. Patient has used alpha-adrenergic receptor-blocking agents 6 weeks or alpha-adrenergic agonists 4 weeks prior to Baseline.
- #12. Patient has ocular rosacea and/or blepharitis/meibomianitis and requires treatment by an ophthalmologist during the study.
- #13. Patient has sunburns, unevenness in skin tones, tattoos, scars, excessive hair (e.g., beard, moustache), freckles, birthmarks, moles, oedematous lesions or other skin damage or abnormality that would result in the inability to perform study assessments.
- #14. Patient has an active or potentially recurring skin conditions(s) other than rosacea that may interfere with the rosacea assessment of or require topical or systemic treatment that may affect treatment assessments.
- #15. Patient has used systemic or other immunosuppressive medications within 4 weeks of the Baseline Visit (inhaled corticosteroid less than or equal to 1000 µg daily dose is acceptable).
- #16. Patient has used phototherapy 14 days prior to Baseline or has had excessive sun exposure with intent to sunbathe or tan or use artificial tanning agents.
- #17. Patient has undergone dermatologic procedures to the face including laser, intense pulsed light, chemical peels, salabrasion, dermabrasion or botulinum toxin injection within 4 weeks of the Baseline Visit.
- #18. Patient has other dermatological conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, acne or atopic dermatitis.
- #19. Patient has participated in another investigational medication or device research study within 30 days of the Screening Visit or five half-lives of the medication, whichever is longer.
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Interventions
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.
Locations(1)
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ACTRN12621000689875