NCT04066725

Aspirin as an Ultraviolet (UV) Protectant in Human Subjects at Risk for Melanoma

A Phase II Placebo-controlled Intervention Trial of Oral Aspirin (ASA) as a UV Protectant in Vivo

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II placebo-controlled intervention trial assessing aspirin (ASA) as a UV protectant in patients at risk for melanoma.

Detailed description

While melanoma risk is largely genetically determined, exposure to ultraviolet (UV) radiation in sunlight is the major environmental risk factor. Although sunscreen use can reduce melanoma risk 2-fold, its efficacy has been questioned, and most patients do not apply sunscreens properly. This study will evaluate the downstream effects of aspirin (ASA) in human blood and skin moles (nevi) following oral ingestion. We will determine if chronic ingestion of ASA can modulate UV-sensitivity of the skin, UV-induced damage in nevi, and PGE2 levels in blood and nevi.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
DRUG	Aspirin 81 mg	Participants will be given ASA 81 mg orally once daily for a total of 60 days
DRUG	Aspirin 325mg	Participants will be given ASA 325 mg orally once daily for a total of 60 days
DRUG	Placebo oral tablet	Participants will be given placebo orally once daily for a total of 60 days

Timeline

• Start date: 2019-07-25
• Primary completion: 2021-03-19
• Completion: 2021-03-19
• First posted: 2019-08-26
• Last updated: 2022-02-18

Locations

1 site across 1 country: United States