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NCT04355286 · ClinicalTrials.gov registry record · Phase 1
Bemotrizinol UV Filter Part 1 Clinical PK Evaluation in Topical MUsT Study
A Phase 1 study of Sunscreening Agents and Absorption; Chemicals, sponsored by dsm-firmenich Switzerland.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT04355286 is a Phase 1 study of Sunscreening Agents and Absorption; Chemicals that has completed, run by dsm-firmenich Switzerland. The registered enrollment target is 14 participants, below the 80-participant average among 21 other Sunscreening Agents trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04355286, a Phase 1 study of Sunscreening Agents and Absorption; Chemicals, has completed, sponsored by dsm-firmenich Switzerland.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 80-participant average among 21 other Sunscreening Agents trials with a reported enrollment target (82% lower). The listed sponsor is dsm-firmenich Switzerland, which has 13 total studies on file at ClinicalTrials.gov.
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.
NCT04355286 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.
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.
What interventions are being tested in trial NCT04355286?
The interventions under investigation include: Bemotrizinol (DRUG).
Who is sponsoring clinical trial NCT04355286?
This trial is sponsored by dsm-firmenich Switzerland, which has 13 total clinical trials registered on ClinicalTrials.gov.
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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