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Status:

COMPLETED

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

Lead Sponsor:

AOBiome LLC

Collaborating Sponsors:

Veristat, Inc.

Conditions:

Atopic Dermatitis Eczema

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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...

Detailed Description

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

January 15 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 20 2019

Estimated Enrollment :

122 Patients enrolled

Trial Details

Trial ID

NCT03235024

Start Date

January 15 2018

End Date

March 20 2019

Last Update

October 10 2022

Active Locations (17)

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Page 1 of 5 (17 locations)

1

Central Research Associates

Birmingham, Alabama, United States, 35205

2

Elite Clinical Studies

Phoenix, Arizona, United States, 85018

3

Encino Research Center

Encino, California, United States, 91436

4

Orange County Research Center

Tustin, California, United States, 92780