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Completed

NCT Number: NCT04066725

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aspirin 81 mg

Drug

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

Other names: ASA

Aspirin 325mg

Drug

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

Other names: ASA

Placebo oral tablet

Drug

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

Primary outcomes

  1. Change in minimal erythemal dose (MED) from baseline to day 60.

    Time frame: Change from baseline to day 60

    Baseline minimal erythemal dose (MED) measurements will will be compared to MED results at day 60. We will use the conventional definition of MED as the lowest UV dose resulting in erythema that completely fills the 8-mm irradiated site (homogeneous erythema).

  2. Change in concentration of prostaglandin E2 (PGE2) in plasma from baseline to day 60.

    Time frame: Change from baseline to day 60

    Baseline PGE2 levels in plasma specimens will be compared to PGE2 levels at day 60.

  3. Change in concentration of prostaglandin E2 (PGE2) in nevus tissue from baseline to day 60.

    Time frame: Change from baseline to day 60

    Baseline PGE2 levels in tissue specimens will be compared to PGE2 levels at day 60.

Secondary outcomes

  1. Change in concentration of oncometabolite 2-hydroxyglutarate (2-HG) in plasma from baseline to day 60.

    Time frame: Change from baseline to day 60

    Baseline 2-HG levels in plasma specimens will be compared to 2-HG levels at day 60.

  2. Change in concentration of 8-oxoguanine (8-OG) in plasma from baseline to day 60.

    Time frame: Change from baseline to day 60

    Baseline 8-OG levels in plasma specimens will be compared to 8-OG levels at day 60.

  3. Change in concentration of oncometabolite 2-hydroxyglutarate (2-HG) in nevus tissue from baseline to day 60.

    Time frame: Change from baseline to day 60

    Baseline 2-HG levels in tissue specimens will be compared to 2-HG levels at day 60.

  4. Change in concentration of 8-oxoguanine (8-OG) in nevus tissue from baseline to day 60.

    Time frame: Change from baseline to day 60

    Baseline 8-OG levels in tissue specimens will be compared to 8-OG levels at day 60.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 26, 2019
Registry last updated
Feb 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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