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

NCT04355286 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-02-09

No results posted yet for this 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

  • Absorption; Chemicals
  • Sunscreening Agents

Interventions

DRUG

Bemotrizinol

Market-image topical sunscreen formulation containing BEMT (6%)

Sponsors & Collaborators

  • Spaulding Clinical Research LLC

    collaborator OTHER

  • DSM Nutritional Products, Inc.

    lead INDUSTRY

Principal Investigators

  • Carlos Sanabria, MD · Spaulding Clinical Research LLC

  • Rolf Schultz, PhD · DSM Nutritional Products, LLC

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-03
Primary Completion
2020-11-06
Completion
2020-11-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04355286 on ClinicalTrials.gov