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Bemotrizinol UV Filter Part 1 Clinical PK Evaluation in Topical MUsT Study
NCT04355286 · View on ClinicalTrials.gov ↗
Study Summary
This will be a single clinical study conducted in 2 parts (Part 1: pilot study and Part 2: pivotal study). Part 1 is an open-label, 1-arm study in 14 healthy adult subjects with the following primary objectives: * Primary: To explore whether the active component, bemotrizinol (BEMT), is absorbed from a high-penetrating sunscreen formulation including 6% BEMT into the systemic circulation when applied under maximal-use conditions. * Secondary: To obtain information needed for a successful pivotal study such as preliminary pharmacokinetic (PK) data, validation of study and analytical procedures, and the number of subjects needed. Part 2 is an open-label, randomized, 3-arm study in 42 healthy adult subjects with the following objective: • Primary: To assess the systemic absorption and pharmacokinetics of BEMT from 3 market image sunscreen formulations under maximal-use conditions.
Conditions Studied
Interventions
- DRUG Bemotrizinol
Study Locations (1)
Wisconsin
- Spaulding Clinical Research LLC — West Bend
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2020-11-03 |
| Est. Completion | 2020-11-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04355286
The ClinicalTrials.gov registry entry for NCT04355286 describes a study currently listed as completed. It is categorized as Phase 1, 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 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is dsm-firmenich Switzerland, which has 3 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 Sunscreening Agents appearing as the primary indexed condition, and to 1 intervention — of which Bemotrizinol 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: NCT04355286 reports 1 study location spanning 1 distinct geographic area — top geographies include Wisconsin. 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 NCT04355286 about?
NCT04355286 is a clinical study titled "Bemotrizinol UV Filter Part 1 Clinical PK Evaluation in Topical MUsT Study". This will be a single clinical study conducted in 2 parts (Part 1: pilot study and Part 2: pivotal study). Part 1 is an open-label, 1-arm study in 14 healthy adult subjects with the following primary objectives: * Primary: To explore whether the active component, bemotrizinol (BEMT), is absorbed f...
What is the current status of trial NCT04355286?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2020-11-03. Estimated completion is 2020-11-17.
What conditions does trial NCT04355286 study?
This clinical trial studies the following conditions: Sunscreening Agents, Absorption; Chemicals. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04355286?
The interventions under investigation include: Bemotrizinol (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04355286?
This trial is sponsored by dsm-firmenich Switzerland, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04355286 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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