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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Sun Safety Ink! Program | Experimental | A 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 Control | Active comparator | The 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.
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
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)
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
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.
- First posted30 Mar 2017
- Study start15 Jun 2017
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,820 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klein Buendel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara Walkosz, PhD, Principal investigator, Klein Buendel, Inc.
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sun Safety Ink! A Sun Safety Program for the Tattoo Community
- ClinicalTrials.gov ID
- NCT03096548
- Acronym / sponsor ID
- 0315
- Conditions
- Skin Cancer
- Keywords
- Skin Cancer, Tattoo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,820 participants (actual)
- Lead sponsor
- Klein Buendel, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), University of Colorado, Denver
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 30 Mar 2017 (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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sun Safety Ink! Program | Experimental | Behavioral: Sun Safety Ink! ProgramA 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. |
| Attention Control | Active comparator | Behavioral: Attention ControlThe attention control group will provide standard tattoo aftercare instructions to their clients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must be 18 years of age or older
- Must have received a tattoo in a licensed tattoo studio
Key exclusion criteria (1 listed)
- Under 18 years of age
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 |
|---|---|---|
| Sun Safety Ink! ProgramThe 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. | Behavioural | Sun Safety Ink! Program |
| Attention ControlStudios 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. | Behavioural | Attention Control |
Primary outcome
Change in Sun Protection by Client (online survey)
Time frame: Baseline, 1 Month Posttest, 6 Month Posttest
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.
Change in Number of Sunburns
Time frame: Baseline, 1 Month Posttest, 6 Month Posttest
Participants will report number of sunburns in the past 12 months.
2 secondary outcomes
Change in Tanning Behaviors (online survey)
Time frame: Baseline, 1 Month Posttest, 6 Month Posttest
Change in Tanning Attitudes (online survey)
Time frame: Baseline, 1 Month Posttest, 6 Month Posttest
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 6 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Barbara Walkosz, PhD principal investigator
Klein Buendel, Inc.
2 sites in 1 country: see every site and its status.
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.