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NCT04355286
This will be a single clinical study conducted in 2 parts (Part 1: pilot study and Part 2: pivotal study). Part 1 is an open-label, 1-arm study in 14 healthy adult subjects with the following primary objectives: * Primary: To explore whether the active component, bemotrizinol (BEMT), is absorbed from a high-penetrating sunscreen formulation including 6% BEMT into the systemic circulation when applied under maximal-use conditions. * Secondary: To obtain information needed for a successful pivotal study such as preliminary pharmacokinetic (PK) data, validation of study and analytical procedures, and the number of subjects needed. Part 2 is an open-label, randomized, 3-arm study in 42 healthy adult subjects with the following objective: • Primary: To assess the systemic absorption and pharmacokinetics of BEMT from 3 market image sunscreen formulations under maximal-use conditions.
NCT02750475
To determine the phototoxic potential of a topically applied article in human subjects
NCT02815241
To evaluate the Sun Protection Factor efficacy on human skin.
NCT02930759
To evaluate the Sun Protection Factor efficacy on human skin.
NCT02962856
To determine the phototoxic potential of a topically applied article in human subjects
NCT02962869
To evaluate the potential of a test material to produce a photoallergic response
NCT02774252
To evaluate the Sun Protection Factor efficacy on human skin.
NCT02779270
To assess the safety of a sunscreen product when used outdoor.
NCT02995031
To evaluate the Sun Protection Factor efficacy on human skin.
NCT02995044
To evaluate the Sun Protection Factor efficacy on human skin.
NCT02995109
To evaluate the Sun Protection Factor efficacy on human skin.
NCT02754102
To determine the phototoxic potential of a topically applied article in human subjects.
NCT02728856
To evaluate the human eye irritation potential of two test sunscreen formulation
NCT02751489
To determine the phototoxic potential of a topically applied article in human subjects