None listed
Conditions
Brief summary
BTX 1503 contains the active pharmaceutical ingredient, cannabidiol in a topical liquid formulation, and is being developed for the treatment of acne vulgaris by Botanix Pharmaceuticals Limited. CBD is a member of a broader family of compounds known as cannabinoids, a class of compounds originally derived from the cannabis sativa plant. CBD is chemically synthesized under Good Manufacture Practices (GMP) for use in this study. The objective of this study is to assess safety and efficacy of various doses of BTX 1503 in subjects with moderate to severe acne vulgaris of the face. This will be a multi-center, randomized, double-blinded, vehicle-controlled, parallel group, dose-finding study in pediatrics, adolescents and adults (aged 12 to 40 years). Study participants will be enrolled at sites in Australia and United States of America. Not all sites will enrol paediatric participants. Participants will be randomised to one of five treatment arms: BTX 1503 5%, BID:BTX 1503 5%, QD:BTX 1503, 2.5% QD:Vehicle, BID:Vehicle QD) with 90 subjects in each BTX 1503 group and 45 subjects in each vehicle group for a total of 360 subjects. Participants will be provided with instructions for dose administration and will be asked to self-administer for 28 consecutive days. Safety and cutaneous tolerability will be assessed by the collection and review of AEs and application site review, laboratory parameters throughout the duration of the trial. Efficacy measurements will include change in inflammatory and non-inflammatory lesion counts from baseline. Photography of the face will be conducted for some participants.. Participants will remain in follow up until 84 days following the first application of investigational product, with outpatient visits at Days 1, 14, 28, 56 and 84.
Interventions
Participants will be randomised to one of five treatment groups:
- BTX 1503 5% applied topically twice daily for 84 days
• BTX 1503 5% applied topically once daily for 84 days
• BTX 1503 2.5% applied topically once daily for 84 days
Participants will be provided with a kit containing 4 pumps of investigational product. Each pump will contain enough doses for seven days of dosing. Participants will be asked to record their doses in a diary and study personnel will perform drug accountability at e
Participants will be randomised to one of five treatment groups: - BTX 1503 5% applied topically twice daily for 84 days • BTX 1503 5% applied topically once daily for 84 days • BTX 1503 2.5% applied topically once daily for 84 days Participants will be provided with a kit containing 4 pumps of investigational product. Each pump will contain enough doses for seven days of dosing. Participants will be asked to record their doses in a diary and study personnel will perform drug accountability at each study visit.
Sponsors
Botanix Pharmaceuticals Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
12 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
To be included in the study, subjects with acne vulgaris must meet the following inclusion criteria. - Subject is of either gender and 12 to 40 years of age. - Subject is in good general health without clinically significant haematological, cardiac, respiratory, renal, endocrine, gastrointestinal, psychiatric, hepatic, or malignant disease, as determined by the investigator. - Subject is able and willing to complete the study and to comply with all study instructions and attend the necessary visits. -Subject has acne vulgaris of the face defined as: a. 20 to 50 (inclusive) inflammatory lesions on the face b. 20 to 100 (inclusive) non-inflammatory lesions on the face c. An Investigator Global Assessment (IGA) score for acne severity of 3 or 4 (moderate or severe) assessed on the face. -Subject has less than or <3 nodular/cystic acne lesions (>5 mm in diameter). -Subject must refrain from the use of other treatments for acne during the study. -Subject must agree to not wash or shave their face, swim or otherwise get their face wet for at least 1 hour after application of study medication. -Subject must agree to maintain their regular use of sunscreens, moisturizers, shaving cream, and facial make up throughout the entire course of the study. - Sexually active women of childbearing potential must use appropriate birth control methods.
Exclusion criteria
-People who would otherwise qualify for the study but are living in the same household as a study subject, are not allowed to participate in the study. -Female subject who is breast feeding, pregnant, or planning to become pregnant any time during the course of the study. -Subject has acne conglobata, acne fulminans, secondary acne (chloracne), pseudo-folliculitis, severe acne requiring systemic treatment, or is taking a medication known to induce or exacerbate acne. -Subject has severe truncal acne. -Subject has excessive facial hair that would interfere with the evaluation of safety or with the diagnosis or assessment of acne vulgaris. -Subject 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 evaluate the skin of the face. -Subject has any skin condition of the face other than acne vulgaris. -Subject has used oral retinoid (e.g. isotretinoin) within 6 months (180 days) prior to the -Subject has used Vitamin A supplements greater than 10,000 units/day within 6 months (180 days) prior to the Baseline Visit. -Subject has used androgen receptor blockers (such as spironolactone or flutamide) within 3 months (90 days) prior to the Baseline Visit. -Subject has initiated treatment with hormonal therapy or changed dosing with hormonal therapy within 3 months (90 days) prior to the Baseline Visit. Note: Dose and frequency of any hormonal therapy started more than 3 months (90 days) prior to the Baseline Visit must remain unchanged throughout the study. Hormonal therapies include, but are not limited to, anabolic steroids and birth control pills. Subjects taking testosterone therapy are excluded from participation. -Subject has had facial procedures (chemical or laser peel, microdermabrasion, etc.) within 8 weeks (56 days) prior to the Baseline Visit. -Subject has had treatment with systemic antibiotics within 4 weeks (28 days) prior to the Baseline Visit. -Subject has had treatment with systemic anti-acne drugs within 4 weeks (28 days) prior to the Baseline Visit. -Subject has had treatment with systemic anti-inflammatory drugs within 4 weeks (28 days) prior to the Baseline Visit. Note: Occasional non-steroidal anti-inflammatory drugs (NSAIDs) and aspirin use on an as-needed basis, and if not used consecutively for >14 days prior to the Baseline Visit, is acceptable and does not require washout. Subjects receiving intranasal and inhaled corticosteroids may participate. Low dose (81mg) aspirin taken daily is acceptable. -Subject has had treatment with systemic (oral) corticosteroids other immunosuppressive medications within 4 weeks (28 days) prior to the Baseline Visit. -Subject has had treatment with prescription topical retinoid use on the face (e.g. tretinoin, tazarotene) within 4 weeks (28 days) prior to the Baseline Visit. -Subject has had treatment with topical prescription antibiotics (e.g. dapsone, clindamycin, erythromycin, or sulfacetamide) or combination products that include a topical antibiotic within 2 weeks (14 days) prior to the Baseline Visit. -Subject has had treatment with over-the-counter (OTC) topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, adapalene, a-hydroxy/glycolic acid on the face within 2 weeks (14 days) prior to the Baseline Visit. -Subject has had photodynamic therapy within 8 weeks (56 days) prior to the Baseline Visit. - Subject has used a tanning bed within 2 weeks (14 days) prior to the Baseline Visit. - Subject has used home-based light treatment within 2 weeks (14 days) prior to the Baseline Visit. -Subject 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, atopic dermatitis, psoriasis, perioral dermatitis, or rosacea. -Subject has had excessive sun exposure (in the opinion of the investigator) within one week prior to the Baseline Visit and an unwillingness to refrain from excessive sun exposure during the study.
Outcome results
None listed