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

Completed · Phase 2

Conditions studied: Atopic Dermatitis

In brief

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

Key facts

Study ID

NCT03824405

Run by

Botanix Pharmaceuticals

People needed

200

Starts

2019-02-04

Expected to finish

2020-03-04

Last updated by the study team

2022-10-25

Who can join

Age: 12 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Applied Research Center of Arkansas Inc. — Little Rock, Arkansas, United States
• T. Joseph Raoff MD Inc. / Encino Research Center — Encino, California, United States
• Center for Dermatology Clinical Research — Fremont, California, United States
• Dermatology Specialist Inc. - Murrieta — Murrieta, California, United States
• Rady Childern's Hospital - San Diego — San Diego, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• Precision Clinical Research — Davie, Florida, United States
• Troy Sullivan — North Miami Beach, Florida, United States
• DS Research — Louisville, Kentucky, United States
• Delright Research — New Orleans, Louisiana, United States
• Medisearch Clinical Trails — Saint Joseph, Missouri, United States
• Washington Univerisy in St. Louis — St Louis, Missouri, United States
• JDR Dermatology Research LLC — Las Vegas, Nevada, United States
• The Acne Treatment and Research Center — Morristown, New Jersey, United States
• Aventiv Research Inc - Dublin — Dublin, Ohio, United States
• Greenville Dermatology, LLC — Greenville, South Carolina, United States
• Dermresearch Inc — Austin, Texas, United States
• J&S Studies Inc. — College Station, Texas, United States
• The Center for Skin Research at Suzanne Bruce & Associates Dermatology — Houston, Texas, United States
• CMAX Clincial Research — Adelaide, Australia
• BurwoodDermatology — Burwood, Australia
• Sinclair Dermatology — East Melbourne, Australia
• North Eastern Health Specialists — Hectorville, Australia
• Premier Specialists PTY LTD — Kogarah, Australia
• St George Dermatology & Skin Cancer Center — Kogarah, Australia

Full record on ClinicalTrials.gov

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