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NCT03582215 · ClinicalTrials.gov registry record · Phase 1
Assessment of the Human Systemic Absorption of Sunscreen Ingredients
A Phase 1 study, sponsored by Food and Drug Administration (FDA).
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
NCT03582215 is a Phase 1 study that has completed, run by Food and Drug Administration (FDA). The registered enrollment target is 72 participants.
The verdict
NCT03582215, a Phase 1 study, has completed, sponsored by Food and Drug Administration (FDA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
Study 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).
Interventions
- DRUG Part 1: Cream
- DRUG Part 1: Lotion
- DRUG Part 1: Spray 1
- DRUG Part 1: Spray 2
- DRUG Part 2: Lotion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2018-07-18 |
| Est. Completion | 2019-02-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03582215
The ClinicalTrials.gov registry entry for NCT03582215 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Food and Drug Administration (FDA), which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Part 1: Cream is the first listed.
NCT03582215 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03582215 about?
NCT03582215 is a clinical study titled "Assessment of the Human Systemic Absorption of Sunscreen Ingredients". 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-ar...
What is the current status of trial NCT03582215?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2018-07-18. Estimated completion is 2019-02-18.
What interventions are being tested in trial NCT03582215?
The interventions under investigation include: Part 1: Cream (DRUG), Part 1: Lotion (DRUG), Part 1: Spray 1 (DRUG), Part 1: Spray 2 (DRUG), Part 2: Lotion (DRUG).
Who is sponsoring clinical trial NCT03582215?
This trial is sponsored by Food and Drug Administration (FDA), which has 23 total clinical trials registered on ClinicalTrials.gov.
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