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B244 Topical Spray for the Treatment of Pruritus in Adults With a History of Atopic Dermatitis
NCT04490109 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 547 participants |
| Start Date | 2020-06-24 |
| Est. Completion | 2022-01-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04490109
The ClinicalTrials.gov registry entry for NCT04490109 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 547 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AOBiome, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04490109 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04490109?
The interventions under investigation include: Vehicle (BIOLOGICAL), B244 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04490109?
This trial is sponsored by AOBiome, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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