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Skin CancerNCT03096548

Sun Safety Ink! A Sun Safety Program for the Tattoo Community

A study testing Sun Safety Ink! Program in people with Skin Cancer, run by Klein Buendel, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Over 3.5 million cases of non-melanoma skin cancers occur annually and melanoma rates have doubled in the last 30 years, burdening the nation's health system. Klein Buendel, Inc. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Skin Cancer
What is being tested?
Sun Safety Ink! Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,820 participants
Where
2 sitesUnited States
Study dates
15 Jun 2017to 31 Dec 2022
Phase
Interventional
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Must be 18 years of age or older
  • Must have received a tattoo in a licensed tattoo studio

Who cannot join

  • Under 18 years of age

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • University of Colorado Denver

    Aurora, Colorado, 80045

  • Klein Buendel, Inc.

    Golden, Colorado, 80401

Other trials in United States

About this study

Over 3.5 million cases of non-melanoma skin cancers occur annually and melanoma rates have doubled in the last 30 years, burdening the nation's health system. Klein Buendel, Inc. (KB) proposes to develop Sun Safety INK! (SSI!), a skin cancer prevention program targeted to clients of licensed tattoo studios because tattoo aftercare recommendations can include sun protection for tattoos, and studios offer an opportunity to reach younger adults who are significantly more likely to sunburn and less likely to practice sun safety. The study will assess the effectiveness of SSI! at (1) increasing full-body comprehensive sun protection practices; (2) decreasing sun burning and tanning; and, (3) decreasing positive attitudes regarding tanning and tanning attractiveness.

Read the detailed description

Skin cancer prevention is a public health priority. Over 3.5 million cases of non-melanoma skin cancers (NMSC) occur annually and melanoma rates have doubled in the last 30 years, burdening the nation's health system. Increasing evidence points to the need for prevention programs to be targeted to young adults as invasive melanoma of the skin is the third most common cancer among adolescents and young adults (ages 15-39) in the U.S. Skin cancer is preventable as excess exposure to ultraviolet radiation (UVR), the primary risk factor, is modifiable and a number of public health campaigns have been developed to increase awareness about skin cancer risk and to promote sun safety. Despite these efforts, skin cancer rates continue to rise. Many adults still forget to apply sunscreen, do not pre-apply prior to sun exposure, fail to reapply, do not use clothing or wide-brimmed hats that physically block UVR and do not use shade. 4.2% of US adults engage in indoor tanning. It is well established that continued efforts are needed to promote skin cancer prevention. Concurrently, approximately, 25% of American adults have a tattoo with younger adults more likely to have tattoos than older adults. The popularity of tattoos continues to grow in the general population and particularly among members of the military. Individuals with tattoos need to take extra precaution when exposed to the sun not only to protect themselves from harmful UVR rays but also to reduce damage to their tattoos. Klein Buendel, Inc. (KB) proposes to develop and test Sun Safety INK (SSI), a skin cancer prevention program targeted to clients of licensed tattoo studios. The studios have been selected as the venue for this study because tattoo salons, at times, promote sun protection for new tattoos to keep them from fading, and offer a unique opportunity to reach younger adults who have high sunburn rates and are often less likely to practice sun protection. The studios provide a unique and compatible environment for sun safety promotion. Further, a number of successful programs have promoted health practices through similar venues such as beauty parlors and barber shops. Exploratory research with the tattoo community determined that: (1) tattoo studios were receptive to a skin cancer prevention program; (2) tattooed individuals had high rates of sunburns and low rates of sun protection but were open to receiving sun safety information and (3) a prototype SSI! program confirmed feasibility for recruitment and implementation. Based on these results, KB proposes to fully develop SSI! to include an online sun safety training for artists, a website, and additional sun safety education materials (e.g., social media). KB will work with the Alliance of Professional Tattoo Artists and the National Tattoo Association to recruit 30 licensed studios to participate in a group-randomized pair-matched pretest-posttest controlled quasi-experimental design. The primary outcomes of the study will be to evaluate the effectiveness of SSI! at: (1) increasing full-body comprehensive sun protection practices; (2) decreasing sun burning and tanning; and, (3) decreasing positive attitudes regarding tanning and tanning attractiveness.

Conditions
Skin Cancer
Being tested
Sun Safety Ink! Program, Attention Control
Keywords
Skin Cancer, Tattoo
Medical subject headings
Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sun Safety Ink! ProgramBehavioural

    The intervention will be comprised of an online skin cancer prevention training for all tattoo artists of participating studios. The training will include skin cancer rates and risk factors, tattoo rates, recommendations for sun protection practices, a rationale for the relationship of tattoo care and sun safety, and recommended communication strategies for artists to communicate skin cancer prevention to their clients. Additional printed materials (tip-card for clients, posters) to be displayed in tattoo studios, a Sun Safety Ink! website, and social media messages for tattoo studios' Facebook and Pinterest pages will be provided.

  • Attention ControlBehavioural

    Studios and artists in this attention control group will not receive the Sun Safety Ink! program. They will continue to provide standard aftercare instructions to clients. The program will be provided to them at the end of the study.

Study groups in NCT03096548
Study groupRoleWhat they receive
Sun Safety Ink! ProgramExperimentalA program to (1) increase full-body sun comprehensive sun protection practices, (2) decrease sunburning and tanning and (3) decrease positive attitudes regarding tanning and tanning attractiveness of tattoo studio clients. The program is comprised of a video based communication strategy training presented by research staff to artists of tattoo studios.
Receives: Behavioral: Sun Safety Ink! Program
Attention ControlActive comparatorThe attention control group will provide standard tattoo aftercare instructions to their clients.
Receives: Behavioral: Attention Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Sun Protection by Client (online survey)

    Sun protection practices (sunscreen application/reapplication and Sun Protection Factor (SPF); use of lip balm, hats, protective clothing, sunglasses, shade) of tattooed and non-tattooed skin will be assessed in an online survey.

    Measured: Baseline, 1 Month Posttest, 6 Month Posttest

  2. Change in Number of Sunburns

    Participants will report number of sunburns in the past 12 months.

    Measured: Baseline, 1 Month Posttest, 6 Month Posttest

Secondary outcomes (2)
  1. Change in Tanning Behaviors (online survey)

    Participants will complete an online survey that focuses on tanning frequency for both indoor and outdoor tanning.

    Measured: Baseline, 1 Month Posttest, 6 Month Posttest

  2. Change in Tanning Attitudes (online survey)

    Participants will complete an online survey that focuses on a six-item tanning image scale (1= strongly agree to 5= strongly disagree).

    Measured: Baseline, 1 Month Posttest, 6 Month Posttest

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2017
  2. Study start15 Jun 2017
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

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 N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,820 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03096548
Sponsor's protocol ID
0315
Other IDs
R01CA206569
Status last verified
Feb 2023
First submitted
14 Mar 2017
Last updated
6 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Sun Safety Ink! Program in people with Skin Cancer, run by Klein Buendel, Inc. at 2 sites 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 2 inclusion and 1 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 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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 Sun Protection by Client (online survey) (time frame: Baseline, 1 Month Posttest, 6 Month Posttest). The study lists 2 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 6 Feb 2023.

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