None listed
Conditions
Brief summary
The purpose of this study is to investigate how safe and tolerable BTX 1702 (either as a solution or a gel) is compared to a placebo (either a solution or a gel) when it is applied two times a day for a planned period of 42 days on the face of participants with papulopustular rosacea. The study will also look at whether BTX 1702 (either solution or gel) improves or worsens papulopustular rosacea compared to a placebo (gel or solution) and whether there are differences in the effectiveness of the BTX 1702 solution compared to the BTX 1702 gel. Participants will be monitored for any reactions or signs of irritation that may be caused by BTX 1702.
Interventions
BTX 1702 5% (w/w) Solution or BTX 1702 5% (w/w) Gel.
Applied twice per day for 42 days. 3 mL of study drug applied to the entire face using a applicator swab. Treatment is assigned via randomization code.
All patients will be required to maintain a diary documenting each application of study drug. Patients will return the study drug bottles and swabs (used and unused) at each visit so that the clinical site staff can ensure patient compliance with dosing.
Sponsors
Botanix Pharmaceuticals Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient has a diagnosis at Screening and Baseline of papulopustular rosacea of the face defined as: a. 15 to 75 (inclusive) inflammatory lesions (papules/pustules) on the face; b. An Investigator’s Global Assessment (IGA) score for rosacea severity of 3 or 4 (moderate or severe), assessed on the face. c. Clinician’s Erythema Assessment (CEA) score of 3 or 4 (moderate or severe) assessed on the face. d. Absence of comedones. e. Independent reviewer confirmation of rosacea patients with erythema and papules/pustules of the face. 2. Patient has <2 nodular lesions (>5 mm in diameter). 3. Absence or presence of telangiectasia. 4. Patient agrees to not use marijuana or cannabidiol (CBD) products throughout the study. 5. A negative urine pregnancy test result for all women of child-bearing potential at the Screening Visit and Baseline Visit. 6. Sexually active women must agree to use contraception throughout the study and for 30 days after last study drug application. 7. Male patients must refrain from sperm donation during the course of the study and until 90 days post study drug administration.
Exclusion criteria
1. Patient with a history of known or suspected intolerance to the drug product excipients (hexamethyldisiloxane, dimethicone, polypropylene glycol (PPG) 15 stearyl ether) and Silicone Gum 1515. 2. Patient has used any marijuana products, via any route, within 4 weeks prior to the Screening Visit. A positive urine drug screen for tetrahydrocannabinol (THC) will exclude the patient. 3. Patient has any significant active infection. 4. Patient has known human immunodeficiency viruses (HIV) infection or hepatitis B or C. 5. Patient has initiated a hormonal method contraception within 3 months of Baseline or plans to discontinue during the course of the study, or changed product within 3 months of Baseline or plans to change during the course of the study. 6. Patient has used topical acne or rosacea treatments within 4 weeks of Baseline. 7. Patient has used systemic retinoids within 90 days of Baseline. 8. Patient has used topical or systemic antibiotics within 4 weeks of Baseline. 9. Patient is using or plans to use a clinically significant concomitant/prohibited drug therapy, treatment or procedure.. 10. Patient has used (>14 days) topical or systemic anti-inflammatories in the 4 weeks prior to Baseline. 11. Patient has used topical or systemic corticosteroids 4 weeks prior to Baseline. 12. Patient has used vasodilating agents (eg. anti-hypertensives, erectile dysfunction drugs, nitroglycerin) 6 weeks prior to Baseline. 13. Patient has used alpha-adrenergic receptor-blocking agents 6 weeks or alpha-adrenergic agonists 4 weeks prior to Baseline. 14. Patient has ocular rosacea and/or blepharitis/meibomianitis and require treatment by an ophthalmologist during the course of the study. 15. Patient has sunburns, unevenness in skin tones, tattoos, scars, excessive hair, freckles, birthmarks, moles, or other skin damage or abnormality that would result in the inability to perform study assessments. 16. Patient has an active or potentially recurring skin conditions(s) other than rosacea that will interfere with the assessment of rosacea. 17. Patient has clinically significant or severe allergies that in the investigator’s opinion would interfere with participation in the study. 18. 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). 19. 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. 20. 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.
Outcome results
None listed