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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: Completed Phase 1 study of Sunscreening Agents and Absorption; Chemicals, sponsored by dsm-firmenich Switzerland.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
• To explore whether the active component, bemotrizinol (BEMT), is absorbed from a high-penetrating sunscreen formulation into the systemic circulation when applied 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 |
What the finished NCT04355286 record still lists
NCT04355286 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 80-participant average among 21 other Sunscreening Agents trials with a reported enrollment target (82% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Sunscreening Agents
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04355286's enrollment target sits among peer trials
14 10th of 21 higher than 11 of 21 other Sunscreening Agents trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sunscreening Agents 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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