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Pharmacokinetic (PK) Evaluation of Bemotrizinol (6%) in a Sunscreen Maximum Usage Trial

NCT05277376 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2023-02-22

No results posted yet for this study

Summary

An open-label, randomized, 3-arm study in 162 healthy adult subjects with the following primary objective: To assess the systemic absorption and pharmacokinetics of BEMT from 3 market image sunscreen formulations under maximal-use conditions.

Conditions

  • Pharmacokinetics
  • Absorption; Chemicals

Interventions

DRUG

Bemotrizinol (6%)

Active sunscreen ingredient (Broad spectrum UV-Filter)

Sponsors & Collaborators

  • DSM Nutritional Products, Inc.

    lead INDUSTRY

Principal Investigators

  • Jennifer Boston, MSN, APNP · Spaulding Clinical Research LLC

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2022-03-15
Primary Completion
2022-10-28
Completion
2022-10-28
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 NCT05277376 on ClinicalTrials.gov