Study of the Safety, Tolerability and Efficacy of BTX 1204 in Patients With Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: BTX 1204; Vehicle
Intervention description: BTX 1204 liquid formulation; Vehicle liquid formulation
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 200.0
Sex: All
Minimum age: 12 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: CBD; Synthetic CBD; Cannabidiol

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

Eligibility criteria:

        Inclusion Criteria:

          1. Subject is of either gender between 12 and 70 years of age, inclusive.

          2. Subject (or parent/legal guardian) has the ability and willingness to sign a written
             informed consent.

          3. Subject has a diagnosis of chronic (≥1 year), stable atopic dermatitis (AD)

          4. Subject has ≥ 5% and ≤ 30% body surface area (BSA) of AD involvement excluding the
             scalp and groin.

          5. Subject has an Investigator's Global Assessment (IGA) score of moderate (3) atopic
             dermatitis on the 5-point IGA (0-4) scale.

          6. 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.

          7. 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.

          8. Subject has suitable venous access for blood sampling.

          9. Subject is able and willing to complete the study and to comply with all study
             instructions and attend the necessary visits.

         10. 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.

         11. A negative urine pregnancy test result for all Women of child bearing potential
             (WOCBP) at the Screening Visit and Baseline Visit.

         12. 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.

               1. One of these highly effective contraception methods Intrauterine device (IUD);
                  hormonal (injections, implants, transdermal patch, vaginal ring); tubal ligation;
                  partner vasectomy, OR

               2. Oral contraceptives WITH a barrier method (listed below), OR

               3. Two barrier forms of contraception (listed below) Male or female condom;
                  diaphragm; cervical cap; contraceptive sponge.

         13. Males subjects must refrain from sperm donation during the study treatment period and
             until 90 days after last study drug application.

        Exclusion Criteria:

          1. Female subject who is breast feeding, pregnant, or planning to become pregnant.

          2. Subject who has an IGA score of 2 (mild) or 4 (severe).

          3. Subject with history of known or suspected intolerance to the drug product excipients.

          4. Subject has any clinically significant active infection in the investigator's opinion.
             This includes active impetigo at any AD lesion.

          5. Subject has known Hepatitis-B, Hepatitis-C, or HIV infection.

          6. Subject has excessive body or facial hair that would interfere with the evaluation of
             safety or with the diagnosis or assessment of AD.

          7. 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.

          8. Subject has clinically significant or severe allergies that in the investigator's
             opinion would interfere with participation in the study.

          9. Subject has known intolerability to topical treatments e.g., reports excessive
             burning/stinging or pain with use of topical treatments.

         10. 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.

         11. Subject has unstable AD consistent with a requirement for high-potency
             corticosteroids.

         12. Subject has used dupilumab (Dupixent) within 12 weeks prior to the Baseline Visit.

         13. Subject has used any biologic therapy, other than dupilumab, within 28 days prior to
             the Baseline Visit.

         14. Subject has used systemic (oral, IV or IM) corticosteroids within 28 days prior to the
             Baseline Visit. Intra-articular injection for arthroses allowed.

         15. Subject has used topical anti-pruritics (e.g., PDE4 inhibitors) within 28 days prior
             to the Baseline Visit.

         16. 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.

         17. Subject has used phototherapy, tanning beds, or any other artificial light device
             within 28 days prior to the Baseline Visit.

         18. Subject has used topical corticosteroids within 14 days prior to the Baseline Visit.

         19. Subject has used topical calcineurin inhibitors within 14 days prior to the Baseline
             Visit.

         20. Subjects has used barrier creams (e.g., Mimyx, Atopiclair), within 7 days prior to the
             Baseline Visit.

         21. Subject has an underlying disease that requires the use of interfering topical or
             systemic therapy.

         22. 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.

         23. 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.

         24. Subject has a clinically relevant history of or current evidence of abuse of alcohol
             or other drugs.

         25. 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.

         26. 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.

         27. Any other reason that would make the subject, in the opinion of the Investigator or
             sponsor, unsuitable for the study.