A Randomised, Double-Blind, Vehicle-Controlled Study of the Safety and Tolerability of BTX 1702 in Patients with Papulopustular Rosacea
- Conditions
- Papulopustular RosaceaSkin - Dermatological conditions
- Registration Number
- ACTRN12621000689875
- Lead Sponsor
- Botanix Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 133
#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.
#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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method