Study of the Safety, Tolerability and Efficacy of BTX 1204 in Patients With Moderate Atopic Dermatitis

Study Overview
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Brief Summary
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This is a randomized, double-blind, vehicle-controlled, Phase 2 study in subjects with moderate AD.

Detailed Description
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This is a randomized, double-blind, vehicle-controlled, Phase 2 study in subjects with moderate AD. Eligible subjects will be enrolled and randomized to treatment with BTX 1204 or Vehicle for 84 days. Approximately two hundred (200) subjects will be enrolled. Subjects will receive BID application of study drug for 84 days with a final application on the evening of Day 84 for a total of 168 doses.

Official Title
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A Randomized, Double-Blind, Vehicle-Controlled Study of the Safety, Tolerability and Efficacy of BTX 1204 in Patients With Moderate Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: BTX 1204
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is of either gender between 12 and 70 years of age, inclusive. Subject (or parent/legal guardian) has the ability and willingness to sign a written informed consent. Subject has a diagnosis of chronic (≥1 year), stable atopic dermatitis (AD) Subject has ≥ 5% and ≤ 30% body surface area (BSA) of AD involvement excluding the scalp and groin. Subject has an Investigator's Global Assessment (IGA) score of moderate (3) atopic dermatitis on the 5-point IGA (0-4) scale. For selected photography sites, subject has a target lesion of 25 to 200 cm2 in surface area on the trunk, upper extremities or lower extremities with a Baseline Signs of AD score of ≥ 6 and ≤ 12. Subject is in good general health without clinically significant hematological, cardiac, respiratory, renal, endocrine, gastrointestinal, psychiatric, hepatic, or malignant disease, as determined by the investigator. Subject has suitable venous access for blood sampling. Subject is able and willing to complete the study and to comply with all study instructions and attend the necessary visits. Male subjects and their partners must agree and commit to use a barrier method of contraception throughout the study and for 90 days after last study drug application. A negative urine pregnancy test result for all Women of child bearing potential (WOCBP) at the Screening Visit and Baseline Visit. Sexually active women must agree to use the following throughout the study and for 30 days after last study drug application. WOCBP who are not sexually active at Baseline and become sexually active must identify a plan for contraception. One of these highly effective contraception methods Intrauterine device (IUD); hormonal (injections, implants, transdermal patch, vaginal ring); tubal ligation; partner vasectomy, OR Oral contraceptives WITH a barrier method (listed below), OR Two barrier forms of contraception (listed below) Male or female condom; diaphragm; cervical cap; contraceptive sponge. Males subjects must refrain from sperm donation during the study treatment period and until 90 days after last study drug application. Exclusion Criteria: Female subject who is breast feeding, pregnant, or planning to become pregnant. Subject who has an IGA score of 2 (mild) or 4 (severe). Subject with history of known or suspected intolerance to the drug product excipients. Subject has any clinically significant active infection in the investigator's opinion. This includes active impetigo at any AD lesion. Subject has known Hepatitis-B, Hepatitis-C, or HIV infection. Subject has excessive body or facial hair that would interfere with the evaluation of safety or with the diagnosis or assessment of AD. 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 AD lesions. Subject has clinically significant or severe allergies that in the investigator's opinion would interfere with participation in the study. Subject has known intolerability to topical treatments e.g., reports excessive burning/stinging or pain with use of topical treatments. Subject has an active or potentially recurring skin conditions(s) other than AD that in the investigator's opinion would interfere with participation in the study. Subject has unstable AD consistent with a requirement for high-potency corticosteroids. Subject has used dupilumab (Dupixent) within 12 weeks prior to the Baseline Visit. Subject has used any biologic therapy, other than dupilumab, within 28 days prior to the Baseline Visit. Subject has used systemic (oral, IV or IM) corticosteroids within 28 days prior to the Baseline Visit. Intra-articular injection for arthroses allowed. Subject has used topical anti-pruritics (e.g., PDE4 inhibitors) within 28 days prior to the Baseline Visit. If subject is taking oral antihistamines, subject has not been on a stable dose of oral antihistamines within 28 days prior to the Baseline visit. Subject has used phototherapy, tanning beds, or any other artificial light device within 28 days prior to the Baseline Visit. Subject has used topical corticosteroids within 14 days prior to the Baseline Visit. Subject has used topical calcineurin inhibitors within 14 days prior to the Baseline Visit. Subjects has used barrier creams (e.g., Mimyx, Atopiclair), within 7 days prior to the Baseline Visit. Subject has an underlying disease that requires the use of interfering topical or systemic therapy. 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, acne or rosacea. 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 or interfere with the subject's participation in the study. Subjects with other dermatologic conditions, including genetic syndromes that have an eczematous dermatitis as a component of the disease (e.g., Netherton's) are excluded. Subject has a clinically relevant history of or current evidence of abuse of alcohol or other drugs. Subject is currently using any medication that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk. Subject 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. Any other reason that would make the subject, in the opinion of the Investigator or sponsor, unsuitable for the study.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BTX 1204<br>BTX 1204 twice daily | Drug: BTX 1204<br>* BTX 1204 liquid formulation<br>|
| Placebo Comparator: Vehicle<br>Vehicle twice daily | Drug: Vehicle<br>* Vehicle liquid formulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's Global Assessment (IGA) | Investigator's Global Assessment (IGA) success defined as an IGA score of Clear (0) or Almost Clear (1) with at least a 2-grade improvement | Day 85 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBD, Synthetic CBD, Cannabidiol