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

Utah System of Higher Education (USHE)

Status and phase: Completed; Phase 2

Conditions: Melanoma (Skin)

Treatments: Drug: Aspirin 81 mg; Drug: Placebo oral tablet; Drug: Aspirin 325mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04066725

HCI94424

Details and patient eligibility

About

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

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must have at least 2 nevi (each >5 mm diameter) not clinically suspicious for melanoma that can be biopsied.
• Must be older than age 18.
• Must be able to receive informed consent and sign an approved consent form that conforms to federal and institutional guidelines.

Exclusion criteria

• The patient cannot speak / understand English or Spanish.
• The patient is pregnant or breastfeeding.
• The patient is a prisoner, critically or mentally ill, or otherwise incapacitated or considered vulnerable.
• The patient has history of allergic reaction to ASA.
• The patient has history of severe asthma.
• The patient has been taking ASA or any NSAID in the past 2 weeks.
• The patient has been taking a blood thinner in the past 2 weeks.
• The patient has history of bleeding disorder.
• The patient has history of peptic ulcer disease.
• The patient has had recent intense UV exposure in the past month.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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95 participants in 3 patient groups, including a placebo group

ASA 81 mg daily

Experimental group

Description:

Participants will be given ASA 81 mg orally once daily for a total of 60 days

Treatment:

Drug: Aspirin 81 mg

ASA 325 mg daily

Experimental group

Description:

Participants will be given ASA 325 mg orally once daily for a total of 60 days.

Treatment:

Drug: Aspirin 325mg

Placebo

Placebo Comparator group

Description:

Participants will be given a placebo orally once daily for a total of 60 days.

Treatment:

Drug: Placebo oral tablet