Assessment of the Human Systemic Absorption of Sunscreen Ingredients
Status:
Completed
Trial end date:
2019-02-18
Target enrollment:
Participant gender:
Summary
This study is designed to assess the systemic exposure and pharmacokinetics of sunscreen
active ingredients (avobenzone, oxybenzone, ecamsule, octocrylene homosalate, octisalate and
octinoxate) when sunscreen product is applied under maximal use conditions.
Part 1 is an open-label, randomized, 4-arm study in 24 healthy adult subjects with the
primary objective to explore whether the active components (avobenzone, oxybenzone, ecamsule
and octocrylene) of 4 sunscreen products (1 sunscreen product in each arm) are absorbed into
the systemic circulation when a sunscreen product is applied under maximal use conditions.
One sunscreen product with the highest avobenzone exposure will be selected for the second
part of the study. If there is no quantifiable exposure of avobenzone for any of the
sunscreen products, the formulation with the highest oxybenzone exposure will be selected for
Part 2. In addition, 3 new sunscreen products are included in Part 2.
Part 2 is an open label, 4-arm study in 48 healthy adult subjects with the primary objective
to assess the pharmacokinetics of the active components in the selected product from Part 1
and 3 additional products with a combination of active ingredients (avobenzone, oxybenzone,
octocrylene, ecamsule homosalate, octisalate and octinoxate as applicable/contained in the
different products).