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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: Completed Phase 2 study of Atopic Dermatitis and Pruritus, sponsored by AOBiome.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Worst itch intensity (WI-NRS) during a 24-hour recall period will be captured. The question for WI-NRS would be, "Please rate the itching severity due to your atopic dermatitis
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 |
What the finished NCT04490109 record still lists
NCT04490109 is an interventional study that assigns participants to a tested intervention. The registered 547 participants enrollment target is mid-sized for trials with a published cap, below the 606-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (10% lower).
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 names 20 study sites across 6 states, led by 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.
Learn More About Clinical Trials
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Where NCT04490109's enrollment target sits among peer trials
547 22nd of 150 higher than 129 of 150 other Atopic Dermatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atopic Dermatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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