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Dermal Irritation, Sensitization and Cumulative Irritation Potential of 6% Bemotrizinol

NCT05260359 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2022-08-26

No results posted yet for this study

Summary

The purpose of this clinical trial is to evaluate the dermal safety of Bemotrizinol (6%).

Conditions

  • Sunburn

Interventions

DRUG

6% Bemotrizinol (BEMT) in a basic sunscreen oil formulation

SU E 101413 85

DRUG

6% Bemotrizinol (BEMT) dispersion in petrolatum

SU-E-101413-82

OTHER

Sunscreen oil vehicle with 10% ethanol as penetration enhancer without BEMT

SU E 101413 91

OTHER

Petrolatum vehicle

SU-E-101413-83

OTHER

0.9% Saline

low irritancy control

OTHER

Sodium Lauryl Sulfate 0.1% (SLS)

positive control

OTHER

Undosed patch

negative control

Sponsors & Collaborators

  • DSM Nutritional Products, Inc.

    lead INDUSTRY

Principal Investigators

  • Samantha Poweski · Eurofins CRL Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-02-23
Primary Completion
2022-04-08
Completion
2022-04-08
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 NCT05260359 on ClinicalTrials.gov