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Photoallergic Potential of 6% Bemotrizinol

NCT05254912 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-08-26

No results posted yet for this study

Summary

This clinical trial will assess the photoallergic potential of BEMT (6%), compared to a vehicle control and a negative control.

Conditions

  • Photoallergic Response

Interventions

DRUG

6% Bemotrizinol in sunscreen formulation

6% Bemotrizinol (BEMT) in a basic sunscreen oil formulation (SU E 101413 85)

DRUG

6% Bemotrizinol in petrolatum

6% Bemotrizinol (BEMT) as a dispersion in petrolatum (SU-E-101413-82)

OTHER

Vehicle

Sunscreen oil vehicle with 10% ethanol as penetration enhancer without BEMT (SU E 101413 91)

Sponsors & Collaborators

  • DSM Nutritional Products, Inc.

    lead INDUSTRY

Principal Investigators

  • Rolf Schutz, PhD · DSM Nutritional Products, Inc.

  • Gladys Osis, MT · Eurofins CRL Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2022-03-07
Primary Completion
2022-04-22
Completion
2022-04-22
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 NCT05254912 on ClinicalTrials.gov