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Skin Cancer Prevention Strategies for Skin Cancer (RISE-UP Trial)

Phase 3

Recruiting

Led By Yelena Wu, PhD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Report having at least one sunburn in the last year

Report intentional or unintentional outdoor tanning "sometimes," "often," or "always"

Must not have

Self-reported personal history of skin cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1-month post-intervention, 3-months post-intervention, 15-months post-intervention

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to identify intervention approaches that help people avoid sunburn and motivate sun protection, by testing 3 personalized risk components over 1 year with 528 people.

Who is the study for?

This trial is for undergraduate students over 18 who have tanned indoors once in the past year, experienced at least one sunburn last year, and use sunscreen or other sun protection infrequently. They must also engage in outdoor tanning to some degree. Those with a history of skin cancer or who don't read/speak English cannot participate.

What is being tested?

The study tests whether UV photos, an action plan for sun protection, and MC1R genetic testing can prevent sunburns among undergraduates. Participants will be assessed four times over 15 months to see which methods work best alone or combined.

What are the potential side effects?

Since this trial involves non-invasive interventions like education and planning without medical treatments, significant side effects are not expected. However, participants may experience discomfort from confronting personal risk factors for skin cancer.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had at least one sunburn in the past year.

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I sometimes, often, or always tan outdoors intentionally or unintentionally.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had skin cancer before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1-month post-intervention, 3-months post-intervention, 15-months post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1-month post-intervention, 3-months post-intervention, 15-months post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1-month post-intervention, 3-months post-intervention, 15-months post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Sunburn Occurrence

Secondary study objectives

Change in Intentional Tanning Behaviors

Change in Sun Protection Behaviors

Change in UVR Exposure

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

8Treatment groups

Experimental Treatment

Group I: Education + UV Photo + MC1R TestExperimental Treatment3 Interventions

Students in this intervention will receive education on skin cancer and prevention strategies, receive a printout of a photo of their face in visible light and UV light from the VISIA Complexion Analysis system, and provide a saliva sample using an Oragene® clinical-grade saliva kit and receive individualized results following MC1R sequencing.

Group II: Education + UV PhotoExperimental Treatment2 Interventions

Students in this intervention will receive education on skin cancer and prevention strategies and receive a printout of a photo of their face in visible light and UV light from the VISIA Complexion Analysis system.

Group III: Education + MC1R TestExperimental Treatment2 Interventions

Students in this intervention will receive education on skin cancer and prevention strategies and provide a saliva sample using an Oragene® clinical-grade saliva kit and receive individualized results following MC1R sequencing.

Group IV: Education + Action Plan + UV Photo + MC1R TestExperimental Treatment4 Interventions

Students in this intervention will receive education on skin cancer and prevention strategies, complete an individualized sun protection and tanning worksheet for situations in which they receive UVR exposure, receive a printout of a photo of their face in visible light and UV light from the VISIA Complexion Analysis system, and provide a saliva sample using an Oragene® clinical-grade saliva kit and receive individualized results following MC1R sequencing.

Group V: Education + Action Plan + UV PhotoExperimental Treatment3 Interventions

Students in this intervention will receive education on skin cancer and prevention strategies, complete an individualized sun protection and tanning worksheet for situations in which they receive UVR exposure, and receive a printout of a photo of their face in visible light and UV light from the VISIA Complexion Analysis system.

Group VI: Education + Action Plan + MC1R TestExperimental Treatment3 Interventions

Students in this intervention will receive education on skin cancer and prevention strategies, complete an individualized sun protection and tanning worksheet for situations in which they receive UVR exposure, and provide a saliva sample using an Oragene® clinical-grade saliva kit and receive individualized results following MC1R sequencing.

Group VII: Education + Action PlanExperimental Treatment2 Interventions

Students in this intervention will receive education on skin cancer and prevention strategies and complete an individualized sun protection and tanning worksheet for situations in which they receive UVR exposure.

Group VIII: EducationExperimental Treatment1 Intervention

Students in this intervention will receive education on skin cancer and prevention strategies.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Education

2017

N/A

~4790

Action Plan

2020