NCT03582215 - Assessment of the Human Systemic Absorption of Sunscreen Ingredients | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 18, 2018

Primary Completion Date

February 18, 2019

Study Completion Date

February 18, 2019

Conditions

Systemic Exposure to Sunscreen Ingredients

Interventions

DRUG

Part 1: Cream

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

DRUG

Part 1: Lotion

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

DRUG

Part 1: Spray 1

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

DRUG

Part 1: Spray 2

Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area

DRUG

Part 2: Lotion

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

DRUG

Part 2: Aerosol Spray

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

DRUG

Part 2: Nonaerosol Spray

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

DRUG

Part 2: Pump Spray

Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area

Trial Locations (1)

53095

Spaulding Clinical Research, West Bend

All Listed Sponsors

collaborator

Spaulding Clinical Research LLC

OTHER

lead

Food and Drug Administration (FDA)

FED