Study to Determine Safety and Efficacy of B244 in Subjects With Mild to Moderate Atopic Dermatitis

Completed · Phase 2

Conditions studied: Atopic Dermatitis Eczema

In brief

This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 28 days vs vehicle application on treatment of mild to moderate AD

Key facts

Study ID

NCT03235024

Run by

AOBiome LLC

People needed

122

Starts

2018-01-15

Expected to finish

2019-03-20

Last updated by the study team

2022-10-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects ≥18 years of age
• In good general health as determined by a thorough medical history and physical examination, and vital signs
• Clinical diagnosis of mild to moderate atopic dermatitis according to the criteria of Hanifin and Rajka
• Mild to moderate Atopic Dermatitis area and severity index [EASI] 10-21
• A score of at least ≥ 5 points (moderate pruritus) on the VAS for pruritus
• A minimum of 10% and not more than 30% of the subjects' BSA affected by atopic dermatitis (affected is defined by physical examination findings: erythema, edema, scaling, lichenification, excoriation, with the excoriation serving as the physical examination correlate of pruritus)
• An IGA score of 2-3
• Patient has a history of AD for ≥12 months
• Ability to read and understand English and to provide written informed consent and authorization for protected health information disclosure

You may not qualify if…

• Pregnant and lactating women by urine pregnancy testing
• Subjects with any significant clinical abnormalities which may interfere with study participation
• Any skin condition which may interfere with evaluation of AD
• Atopic dermatitis only on the head or scalp
• Subjects with Atopic dermatitis on the face
• Unstable or actively infected atopic dermatitis
• Patients suffering from pruritus from conditions other than AD
• Patients with chronic pruritus due to systemic disease
• Patients with conditions requiring inhaled steroids
• Have concurrent skin disease of such severity in the study area that it could interfere with the study evaluation
• Have active skin infections on the treatment area
• Have received or planning to receive topical corticosteroids, topical coal tar, topical sulfur, topical PDE-4 inhibitors, topical antihistamines, topical antiseptics or antibiotics, topical antifungals, bleach baths, UVA or UVB phototherapy, oral/IV/inhaled steroids, antibiotics/antiviral/antifungal agents, oral probiotics, glucocorticoids treatment, calcineurin inhibitors, immunomodulating biologic agents, systemic glucocorticoids, systemic immunosuppressive or immunomodulatory agents within 2 weeks of Baseline visit.
• Current or recent history (≤3 months of systemic use of Otrexup™, Rasuvo®, Rheumatrex® and Trexall™ or its generic versions such as Methotrexate
• History of being seropositive for human immunodeficiency virus (HIV) at screening by laboratory testing at Screening
• History of being positive for Hepatitis B virus surface antigen (HBsAg) or positive Hepatitis C virus antibody (HCV Ab) at screening by laboratory testing at Screening
• History of renal disease
• Use of any investigational drugs within the previous 30 days prior to dosing or within a period of less than five times the drug's half-life, whichever is longer
• Use of any biologic within a period of 5 times its half-life
• Use of vinegar or bleach baths within 2 weeks of starting the study

Where it is running

• Central Research Associates — Birmingham, Alabama, United States
• Elite Clinical Studies — Phoenix, Arizona, United States
• Encino Research Center — Encino, California, United States
• Orange County Research Center — Tustin, California, United States
• Neostart Corporation d.b.a AGA Clinical Trials — Hialeah, Florida, United States
• Clinical Neuroscience Solution, Inc — Jacksonville, Florida, United States
• FXM Research Corp. — Miami, Florida, United States
• FXM Research Miramar — Miramar, Florida, United States
• Clinical Neuroscience Solution, Inc — Orlando, Florida, United States
• Clinical Research Trials of Florida, Inc. — Tampa, Florida, United States
• Columbus Regional Research Institute — Columbus, Georgia, United States
• DeNova Research dba Arano, LLC — Chicago, Illinois, United States
• Clarkston Skin Research — Clarkston, Michigan, United States
• MediSearch Clinical Trials — Saint Joseph, Missouri, United States
• LoveLace Scientific Resources — Albuquerque, New Mexico, United States
• Central Sooner Research — Norman, Oklahoma, United States
• Paddington Testing Co. — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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