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B244 Topical Spray for the Treatment of Pruritus in Adults With a History of Atopic Dermatitis

NCT04490109 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 547

Last updated 2025-01-28

Study results available
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Summary

This is a double-blind, randomized, vehicle-controlled study to assess the efficacy, safety, and tolerability of 2 doses of B244 for the treatment of pruritus in adults with a history of atopic dermatitis. Subjects who meet the study entry criteria will be randomized in a 1:1:1 ratio to receive twice daily topical doses of B244 O.D. 5.0, B244 O.D. 20.0, or vehicle (placebo) for 4 weeks.

Conditions

Interventions

BIOLOGICAL

B244

B244 suspension

BIOLOGICAL

Vehicle

Vehicle suspension

Sponsors & Collaborators

  • bioRASI, LLC

    collaborator INDUSTRY

  • AOBiome LLC

    lead INDUSTRY

Principal Investigators

  • Hyun Kim, PhD · AOBiome LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-24
Primary Completion
2021-12-10
Completion
2022-01-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04490109 on ClinicalTrials.gov