Bemotrizinol UV Filter Part 1 Clinical PK Evaluation in Topical MUsT 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.

Timeline

Start

2020-11-03

Primary completion

2020-11-06

Completion

2020-11-17

Drugs

Indications

No indication recorded.