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NCT04490109 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Atopic Dermatitis and Pruritus, sponsored by AOBiome.

Completed
Registry status
Phase 2
Development phase
547
Enrollment target
20
Study locations

NCT04490109 is a Phase 2 study of Atopic Dermatitis and Pruritus that has completed, run by AOBiome. The registered enrollment target is 547 participants, below the 606-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (10% lower). The trial reports 20 study locations across 6 states.

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The verdict

NCT04490109, a Phase 2 study of Atopic Dermatitis and Pruritus, has completed, sponsored by AOBiome.

COMPLETED
Registry status
Phase 2
Development phase
547 participants
Enrollment target
20
Study locations

Study 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.

Interventions

  • BIOLOGICAL Vehicle
  • BIOLOGICAL B244

Study Locations (20)

California

  • Core Healthcare Group - Cerritos
  • Encino Research Center - Encino
  • Center for Dermatology, INC - Fremont
  • Antelope Valley Clinical Trials - Lancaster
  • Long Beach Clinical Trials Services - Long Beach
  • L.A. Universal Research Center Inc - Los Angeles
  • Providence Clinical Research - North Hollywood
  • Syrentis Clinical Research - Santa Ana

Florida

  • Tampa Bay Medical Research - Clearwater
  • Palm Beach Dermatology Group - Delray Beach
  • South Coast Research Center, Inc - Miami
  • D&H National Research Center - Miami
  • Meridian International Research - Miami Gardens
  • NAPA Research - Pompano Beach

Arizona

  • Elite Clinical Studies, LLC - Phoenix
  • Cognitive Clinical Trials - Scottsdale

Arkansas

  • Dermatology Trial Associates - Bryant
  • Applied Research Center of Arkansas, Inc - Little Rock

Alabama

  • Cahaba Dermatology - Birmingham

Colorado

  • IMMUNOe Research Centers - Centennial

Trial Details

FieldValue
Enrollment Target 547 participants
Start Date 2020-06-24
Est. Completion 2022-01-07
Phase Phase 2

Sponsor

AOBiome

11 total trials

What the Registry Record Tells You About NCT04490109

The ClinicalTrials.gov registry entry for NCT04490109 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 547 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 606-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (10% lower). The listed sponsor is AOBiome, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Atopic Dermatitis appearing as the primary indexed condition, and to 2 interventions - of which Vehicle is the first listed.

NCT04490109 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT04490109 about?

NCT04490109 is a clinical study titled "B244 Topical Spray for the Treatment of Pruritus in Adults With a History of Atopic Dermatitis". 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 twic...

What is the current status of trial NCT04490109?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 547 participants. The study started on 2020-06-24. Estimated completion is 2022-01-07.

What conditions does trial NCT04490109 study?

This clinical trial studies the following conditions: Atopic Dermatitis, Pruritus.

What interventions are being tested in trial NCT04490109?

The interventions under investigation include: Vehicle (BIOLOGICAL), B244 (BIOLOGICAL).

Who is sponsoring clinical trial NCT04490109?

This trial is sponsored by AOBiome, which has 11 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04490109 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.