Melanoma (Skin)Phase 2NCT04066725
Aspirin as an Ultraviolet (UV) Protectant in Human Subjects at Risk for Melanoma
A Phase 2 study testing Aspirin 81 mg and Aspirin 325mg in people with Melanoma (Skin), run by University of Utah at 1 site in United States.
Trial summary
This is a phase II placebo-controlled intervention trial assessing aspirin (ASA) as a UV protectant in patients at risk for melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- Aspirin 81 mg and Aspirin 325mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2019to 19 Mar 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: A Phase II Placebo-controlled Intervention Trial of Oral Aspirin (ASA) as a UV Protectant in Vivo
This is a phase II placebo-controlled intervention trial assessing aspirin (ASA) as a UV protectant in patients at risk for melanoma.
Read the 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)
- Being tested
- Aspirin 81 mg, Aspirin 325mg, Placebo oral tablet
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 81 mgDrug
Also called ASA
Participants will be given ASA 81 mg orally once daily for a total of 60 days
Aspirin 325mgDrug
Also called ASA
Participants will be given ASA 325 mg orally once daily for a total of 60 days
Placebo oral tabletDrug
Participants will be given placebo orally once daily for a total of 60 days
| Study group | Role | What they receive |
|---|---|---|
| ASA 81 mg daily | Experimental | Participants will be given ASA 81 mg orally once daily for a total of 60 days Receives: Drug: Aspirin 81 mg |
| ASA 325 mg daily | Experimental | Participants will be given ASA 325 mg orally once daily for a total of 60 days. Receives: Drug: Aspirin 325mg |
| Placebo | Placebo comparator | Participants will be given a placebo orally once daily for a total of 60 days. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in minimal erythemal dose (MED) 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).
Measured: Change from baseline to day 60
Change in concentration of prostaglandin E2 (PGE2) in plasma from baseline to day 60.
Baseline PGE2 levels in plasma specimens will be compared to PGE2 levels at day 60.
Measured: Change from baseline to day 60
Change in concentration of prostaglandin E2 (PGE2) in nevus tissue from baseline to day 60.
Baseline PGE2 levels in tissue specimens will be compared to PGE2 levels at day 60.
Measured: Change from baseline to day 60
Secondary outcomes (4)
Change in concentration of oncometabolite 2-hydroxyglutarate (2-HG) in plasma from baseline to day 60.
Baseline 2-HG levels in plasma specimens will be compared to 2-HG levels at day 60.
Measured: Change from baseline to day 60
Change in concentration of 8-oxoguanine (8-OG) in plasma from baseline to day 60.
Baseline 8-OG levels in plasma specimens will be compared to 8-OG levels at day 60.
Measured: Change from baseline to day 60
Change in concentration of oncometabolite 2-hydroxyglutarate (2-HG) in nevus tissue from baseline to day 60.
Baseline 2-HG levels in tissue specimens will be compared to 2-HG levels at day 60.
Measured: Change from baseline to day 60
Change in concentration of 8-oxoguanine (8-OG) in nevus tissue from baseline to day 60.
Baseline 8-OG levels in tissue specimens will be compared to 8-OG levels at day 60.
Measured: Change from baseline to day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start25 Jul 2019
- Primary completion19 Mar 2021
- Study completion19 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas Grossman, MD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066725
- Sponsor's protocol ID
- HCI94424
- Status last verified
- Feb 2022
- First submitted
- 21 Aug 2019
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Placebo-controlled Intervention Trial of Oral Aspirin (ASA) as a UV Protectant in Vivo
- ClinicalTrials.gov ID
- NCT04066725
- Acronym / sponsor ID
- HCI94424
- Conditions
- Melanoma (Skin)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 19 Mar 2021 (actual)
- Study completion
- 19 Mar 2021 (actual)
- First posted
- 26 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASA 81 mg daily | Experimental | Drug: Aspirin 81 mgParticipants will be given ASA 81 mg orally once daily for a total of 60 days |
| ASA 325 mg daily | Experimental | Drug: Aspirin 325mgParticipants will be given ASA 325 mg orally once daily for a total of 60 days. |
| Placebo | Placebo comparator | Drug: Placebo oral tabletParticipants will be given a placebo orally once daily for a total of 60 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin 81 mgAlso: ASAParticipants will be given ASA 81 mg orally once daily for a total of 60 days | Drug | ASA 81 mg daily |
| Aspirin 325mgAlso: ASAParticipants will be given ASA 325 mg orally once daily for a total of 60 days | Drug | ASA 325 mg daily |
| Placebo oral tabletParticipants will be given placebo orally once daily for a total of 60 days | Drug | Placebo |
Primary outcome
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).
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.
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.
4 secondary outcomes
Change in concentration of oncometabolite 2-hydroxyglutarate (2-HG) in plasma from baseline to day 60.
Time frame: Change from baseline to day 60
Change in concentration of 8-oxoguanine (8-OG) in plasma from baseline to day 60.
Time frame: Change from baseline to day 60
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
Change in concentration of 8-oxoguanine (8-OG) in nevus tissue from baseline to day 60.
Time frame: Change from baseline to day 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Grossman, MD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aspirin 81 mg and Aspirin 325mg in people with Melanoma (Skin), run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in minimal erythemal dose (MED) from baseline to day 60. (time frame: Change from baseline to day 60). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.