None listed
Conditions
Brief summary
BTX 1308 contains the active pharmaceutical ingredient, cannabidiol in a topical liquid formulation, and is being developed for the treatment of psoriasis 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 preliminary safety, tolerability, and activity of various formulations and concentrations of BTX 1308 in subjects with mild to moderate, stable, plaque-type psoriasis. This will be a single-center, vehicle and comparator-controlled, evaluator-blinded study in volunteers aged 18 years and over. Participants will receive 4 treatments, across up to 3 comparable psoriasis plaques. BTX 1308 – 1 5% BTX 1308 – 3 20% BTX 1308 Vehicle Approved psoriasis product – Betnovate® (betamethasone valerate) Ointment 0.1% 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 assessments will include measurement of the thickness of the psoriatic inflammatory infiltrate using sonography. Photography of the treated area will be conducted for all participants. Participants will remain in follow up until 19 days following the first application of investigational product.
Interventions
Each subject will have four (4) treatments applied simultaneously by study personnel. Topical occlusive applications of approximately 150 µL per test field (1.1 cm2) will be done once daily during a 19-day study period, except on Days 7, 14, and 19, for a total of 16 treatments
Two formulations of BTX 1308 with the active ingredient cannabidiol (CBD) will be applied:
• BTX 1308-1 5%
• BTX 1308-3 20%
Sponsors
Botanix Pharmaceuticals Limited
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be included in the study, subjects must meet the following inclusion criteria. 1. Subject (or legal guardian) has the ability and willingness to sign a written informed consent. 2. Subject is of either gender and 18 years or older 3. 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. 4. Subject has psoriasis vulgaris in a chronic stable phase and mild to moderate plaque(s) with up to 3 comparable psoriatic plaque(s) sufficient for 4 treatment fields. 5. Subject has the treatment field lesion(s) located on the trunk or extremities (excluding palms/soles); psoriatic lesions on the knees or elbows (joints) are not to be used as treatment fields. 6. Identified treatment fields should have a comparable EPB thickness of the psoriatic infiltrate of at least 200 µm. This will be measured on Day 1. 7. Subject´s physical examination of the skin must be without disease findings other than psoriasis vulgaris unless the investigator considers an abnormality to be irrelevant to the outcome of the clinical trial. 8. A negative urine pregnancy test (UPT) result for all women if childbearing potential (WOCBP) at the Screening Visit and Baseline Visit, if applicable. A WOCBP is one who is not permanently sterilised or is not postmenopausal. Postmenopausal is defined as 24 months with no menses without an alternative medical cause. 9. Sexually active WOCBP must agree to use the following throughout the study and for 30 days after last study drug application: a. One of these highly effective contraception methods i. Intrauterine device (IUD); hormonal (injections, implants, transdermal patch, vaginal ring; tubal ligation; partner vasectomy, OR b. Oral contraceptives WITH a barrier method (listed below), OR c. Two barrier forms of contraception (listed below) i. Male or female condom; diaphragm; cervical cap. 10. Subject is able and willing to complete the study and to comply with all study instructions and attend the necessary visits. 11. Male subjects and their partners must agree and commit to use a barrier method of contraception during the study and for 90 days after last study drug application. 12. Male subjects must refrain from sperm donation during the study treatment period until 90 days after final study drug administration
Exclusion criteria
If a subject meets any of the following exclusion criteria, they may not participate in the study. 1. Subject has other skin disease noted on physical examination that is considered by the investigator to be relevant to the outcome of the trial. 2. Subject has acute guttate psoriasis, erythrodermatic psoriasis or pustular psoriasis. 3. Subject has used any topical anti-psoriatics on plaques potentially to be treated in this trial (including corticosteroids, vitamin D analogues, immunomodulators, retinoids, dithranol and tar, except for salicylic acid and except for treatment on the face, ears and scalp) in the 4 weeks before the Baseline Visit. 4. Subject has used systemic treatment with anti-psoriatics e.g., corticosteroids, cytostatics, or retinoids in the three months before the Baseline Visit. 5. Subject has used biologicals (e.g., ustekinumab, secukinumab, ixekizumab, guselkumab, adalimumab, infliximab and etanercept) within six months before the Baseline Visit. 6. Subject has used UV-therapy within four weeks before the Baseline Visit. 7. Subject has had treatment with any concomitant medication that may affect and provoke or aggravate psoriasis, e.g., antimalarial drugs, lithium, beta-blockers or ACE inhibitors unless on a stable dose for 3 months before the Baseline Visit. 8. Subject has known allergic reactions, irritations or sensitivity to the active ingredients or other components of the study drugs. 9. Subject has contraindications according to summary of product characteristics for betamethasone valerate, the active comparator. 10. Subject is receiving treatment with anticoagulant drugs (biopsy group only), which in the opinion of the investigator will be of concern for the biopsy procedure. 11. Subject has HIV or active virus hepatitis (only applicable for subjects consenting to biopsy sampling). 12. Subject has positive pregnancy test or is nursing. 13. Subject has a history or symptoms of a clinically significant illness in the 4 weeks before first treatment and during the trial that in the opinion of the investigator may place the subject at risk by trial participation or influence the outcome of the trial. 14. Subject has blood pressure above 160 mm Hg (systolic) and/or 95 mm Hg (diastolic) at the Screening Visit. 15. Subject is participating or has participated in the treatment phase of another clinical trial within the last 4 weeks prior to the Baseline Visit. 16. Subject has a clinically relevant history or currently suffering from any disease or condition that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk. This may include respiratory (including chronic asthma requiring repetitive drug interventions), gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, or connective tissue diseases or disorders. 17. Any other reason that would make the subject, in the opinion of the investigator or sponsor, unsuitable for the study.
Outcome results
None listed