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

PHASE2CompletedINTERVENTIONAL
Enrollment

224

Participants

Timeline

Start Date

February 23, 2022

Primary Completion Date

April 8, 2022

Study Completion Date

April 8, 2022

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

Trial Locations (1)

New Jersey

"Eurofins , CRL, Inc."

All Listed Sponsors
lead

DSM Nutritional Products, Inc.

INDUSTRY