None listed
Conditions
Brief summary
The purpose of this study is to describe the safety and tolerability of the study drug compared to the vehicle solution with twice daily dosing in subjects with Atopic Dermatitis. Patients with Atopic Dermatitis aged between 18 and 65 years, inclusive, will participate. BTX 1204 4% Solution or Vehicle Solution will be applied twice daily for 28 days. The study consists of a screening visit (up to 14 days before receiving study treatment) and an enrolment visit initially. There is a visit on Day 8 and Day 15 during the 28 day dosing period. Participants will return to the clinic on Day 29 for safety assessments. The maximum study duration for any participant will be a total of up to 43 days; screening period (up to 14 days), 28 days of treatment and a visit on Day 29.
Interventions
Approximately 36 participants with atopic dermatitis will be enrolled and will receive BTX 1204 4% Solution or Vehicle Solution applied topically on their target lesion twice daily for 28 days. The Vehicle Solution will be identical to the BTX 1204 4% Solution, but without the active ingredient.
At the Day 1 Visit, participants will receive their first study drug application at the clinical site during the morning visit. Participants will be trained in the correct application of the study drug a
Approximately 36 participants with atopic dermatitis will be enrolled and will receive BTX 1204 4% Solution or Vehicle Solution applied topically on their target lesion twice daily for 28 days. The Vehicle Solution will be identical to the BTX 1204 4% Solution, but without the active ingredient. At the Day 1 Visit, participants will receive their first study drug application at the clinical site during the morning visit. Participants will be trained in the correct application of the study drug and provided an ample supply of study drug to complete twice daily dosing through Day 7. The first application of study drug will occur in the morning and the second application approximately 12 hours later. A diary will be maintained documenting compliance with the self-administered application. At the Day 8 Visit, the participant will be provided an ample supply of study drug to complete dosing through Day 14. At the Day 15 Visit, the participant will be provided an ample supply of study drug to complete dosing through Day 28. The final application of study drug will be applied by the participant on the evening prior to the Day 29 Visit.
Sponsors
Botanix Pharmaceuticals Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
To be included in the study, participants must meet the following inclusion criteria. 1. Participant (or legal guardian) has the ability and willingness to sign a written informed consent. 2. Participant is of either gender between 18 and 65 years of age, inclusive. 3. Participant 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. Participant has suitable venous access for blood sampling. 5. Participant is able and willing to complete the study and to comply with all study instructions and attend the necessary visits. 6. Participant has a diagnosis of atopic dermatitis according to Hanifin and Rajka [Hannifin 1980] as it relates to adult truncal or extremity atopic dermatitis, with: a. At least one lesion 25 to 200 cm^2 in surface area (target lesion) b. Target lesion on the trunk, upper extremities or lower extremities c. Target lesion with a Signs of AD score of >= 6 and <= 12 7. Participant has an Investigator’s Static Global Assessment (ISGA) score on the target lesion of mild (2) or moderate (3). 8. Participant agrees to not use marijuana products throughout the study. 9. Male participants and their partners must agree and commit to use a barrier method of contraception. 10. A negative urine pregnancy test (UPT) result for all WOCBP at the Screening Visit and Baseline Visit. A WOCBP is one who is not permanently sterilised or not postmenopausal. Postmenopausal is defined as 12 months with no menses without an alternative medical cause. 11. Sexually active women must agree to use: a. One of these highly effective contraception methods: Intrauterine device (IUD); hormonal (injections, implants, transdermal patch, vaginal ring); tubal ligation; partner vasectomy, OR b. Oral contraceptives WITH a barrier method (Male or female condom; diaphragm; cervical cap; contraceptive sponge), OR c. Two barrier forms of contraception (Male or female condom; diaphragm; cervical cap; contraceptive sponge) 12. Males participants must refrain from sperm donation during the study treatment period and until 90 days post study drug administration.
Exclusion criteria
If a participant meets any of the following exclusion criteria, they may not participate in the study. 1. Female participant who is breast feeding, pregnant, or planning to become pregnant. 2. Participant with history of known or suspected intolerance to the drug product excipients (hexamethyldisiloxane and polypropylene glycol (PPG) 15 stearyl ether). 3. Participant has used any marijuana products, via any route, within 4 weeks prior to the Screening Visit. A urine drug test positive for tetrahydrocannabinol (THC) will exclude the participant. 4. Participant has any significant active infection. 5. Participant has known HIV infection. 6. Participant has atopic dermatitis total body surface area involvement of >35%, excluding involvement of the face, scalp, and groin. 7. Participant has excessive body hair that would interfere with the evaluation of safety or with the diagnosis or assessment of AD. 8. Participant 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 target lesion. 9. Participant has unstable AD consistent with a requirement for high-potency corticosteroids. 10. Participant has an active or potentially recurring skin conditions(s) other than AD. 11. Participant has active impetigo at target lesion. 12. Participant has clinically significant or severe allergies. 13. Participant has used a topical immunomodulator (e.g., pimecrolimus or tacrolimus) within 14 days of the Screening Visit. 14. Participant has used topical corticosteroids to treat atopic dermatitis within 14 days of the Screening Visit. 15. Participant has used topical antibiotics to treat atopic dermatitis lesions within 14 days of Screening Visit. 16. Participant has used systemic or other immunosuppressive medications within 30 days of the Screening Visit (inhaled corticosteroid <= 1000 µg daily dose is acceptable). 17. Participant has used phototherapy within the past 14 days. 18. Participant has an underlying disease that requires the use of interfering topical or systemic therapy. 19. Participant 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 rosacea. 20. Participant 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 participant at undue risk. This may include respiratory (including chronic asthma requiring repetitive drug interventions), gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, or connective tissue diseases or disorders. 21. Participant has a clinically relevant history of or current evidence of abuse of alcohol or other drugs. If the urine drug screen at the Screening Visit is positive for THC, the participant is not eligible to participate. 22. Participant is currently using any medication that, in the opinion of the investigator, may affect the evaluation of the study product or place the participant at undue risk. 23. Participant has participated in another investigational drug or device research study within 30 days of the Screening Visit or five half-lives of the drug, whichever is longer. 24. Any other reason that would make the participant, in the opinion of the investigator or sponsor, unsuitable for the study.
Outcome results
None listed