Sun SensitivityNCT04404907

Deliberate Ultraviolet Light Exposure to Get a Tan by Young Adult Sexual Minority Males

An observational study of Sun Sensitivity, run by Northwestern University at 1 site in United States.

Completed

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

Trial summary

The purpose of this study is to: a) identify enablers and barriers to deliberate ultraviolet light exposure by young sexual minority men (SMM), and b) quantify the extent of their deliberate ultraviolet light exposure. Read more about this study

Who is it for?: Ages 18 to 39 years, men only
Conditions the study is for: Sun Sensitivity
How many people: 537 participants
Where: 1 siteUnited States
Study dates: 15 Jul 2019to 5 Sep 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 39 years
Men only
Adult

Study population: RADAR is a longitudinal study with cohorts from the greater Chicago region recruited between 2008 and 2015. Participants respond to online surveys every 6 months.

Who may be able to join

Young adult SMM (age 18-39)
Able to read English
Have internet access
Willing to complete the online survey

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwestern University Feinberg School of Medicine Department of Dermatology
Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Analysis of Tanning Attitudes and Behaviors by Young Adult Sexual Minority Males in the Greater Chicago Area

Read the detailed description

Aim 1: To develop survey items to assess tanning attitudes and behaviors Nine survey items used by the PI in previous deliberate tanning research were adapted with the expert consensus of members of Northwestern's Institute for Sexual and Gender Minority Health and Wellbeing. Discussions with the PI, research personnel and members of the institute developed the hypothesis that in addition to the previously reported appearance motivations young SMM may be engaging in tanning (indoors or outdoors) as a social activity. A tenth survey item was developed to assess deliberate tanning as a social activity.

Aim 2: Analyze the tanning attitudes and behavior data acquired in an online survey of young adult sexual minority males, who regularly participate in the RADAR study.

RADAR is a longitudinal study with cohorts from the greater Chicago region recruited between 2008 and 2015. The 10 survey items about tanning attitudes and behaviors were added to the online survey that examines SMMs' behavior in the prior 6 months. This is a secondary analysis of registry data acquired by the RADAR study.

Conditions: Sun Sensitivity
Being tested: no intervention
Medical subject headings: Photosensitivity Disorders

What participants receive

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

no interventionOther
This is a secondary analysis of registry data.

Study groups in NCT04404907
Study group	Role	What they receive
Males who never deliberately tan		Males responded to an anonymous online survey that they never deliberately tan Receives: Other: no intervention
Males who ever deliberately tan		Males responded to an anonymous online survey that they had ever deliberately tan Receives: Other: no intervention

What is being measured

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

Outdoor Tanning Motives
The 95 participants who self-reported deliberate tanning responded to 7 online survey items reported in the analysis population description.
Measured: 14 days

Timeline

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

15 Jul 20195 Sep 2020

First posted28 May 2020
Study start15 Jul 2019
Primary completion5 Sep 2020
Study completion5 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Sun SensitivityStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe 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: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 537 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04404907
Sponsor's protocol ID: STU00206314
Status last verified: Dec 2020
First submitted: 22 May 2020
Last updated: 5 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Since all data is deidentified, the results cannot be shared individually; however, the results may be provided to the entire cohort in a newsletter.

Publications

Robinson JK, Wahood S, Stapleton JL. Motives for intentional sunlight exposure among young adult sexual minority men: appearance, relaxation and socialization in a cohort study. Br J Dermatol. 2021 Mar;184(3):563-564. doi: 10.1111/bjd.19609. Epub 2020 Nov 18. No abstract available.
PubMed 33067803

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sun Sensitivity trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Analysis of Tanning Attitudes and Behaviors by Young Adult Sexual Minority Males in the Greater Chicago Area
ClinicalTrials.gov ID: NCT04404907
Acronym / sponsor ID: STU00206314
Conditions: Sun Sensitivity
Study type: Observational
Recruitment status: Completed
Enrolment: 537 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Study start: 15 Jul 2019 (actual)
Primary completion: 5 Sep 2020 (actual)
Study completion: 5 Sep 2020 (actual)
First posted: 28 May 2020 (actual)
Results: Posted 10 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Aim 2: Analyze the tanning attitudes and behavior data acquired in an online survey of young adult sexual minority males, who regularly participate in the RADAR study.

Study design

Observational model: Cohort
Time perspective: Other
Number of arms: 2

Arm	Type	Receives
Males who never deliberately tan	–	Other: no interventionMales responded to an anonymous online survey that they never deliberately tan
Males who ever deliberately tan	–	Other: no interventionMales responded to an anonymous online survey that they had ever deliberately tan

Who may qualify

Ages: 18 to 39 years
Sex: Male only
Age groups: Adult
Study population: RADAR is a longitudinal study with cohorts from the greater Chicago region recruited between 2008 and 2015. Participants respond to online surveys every 6 months.

Key inclusion criteria (4 listed)

Young adult SMM (age 18-39)
Able to read English
Have internet access
Willing to complete the online survey

Key exclusion criteria (1 listed)

None

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
no interventionThis is a secondary analysis of registry data.	Other	Males who ever deliberately tan, Males who never deliberately tan

Primary outcome

Outdoor Tanning Motives
Time frame: 14 days
The 95 participants who self-reported deliberate tanning responded to 7 online survey items reported in the analysis population description.

Results and safety

Results posted to the registry on 10 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Males Who Never Deliberately Tan	442	442
Males Who Ever Deliberately Tanned	95	95

Primary outcome: Outdoor Tanning Motives

Time frame: 14 days. Mean (Standard Deviation). Unit: score on a scale

Measure	Occasional Tanning n = 88	Frequent Tanning n = 7
Most other gay and bisexual guys like me feel more attractive with a tan	3.64 (1.01)	3.81 (1.05)
Tanning helps me relax	4.10 (0.78)	4.29 (0.70)
Feel more confident with a tan	3.09 (0.80)	3.03 (1.13)
Go tanning with others as a social activity	4.09 (0.80)	4.55 (0.31)
Important to protect skin from the sun	3.07 (0.73)	3.00 (1.10)
Concern about skin cancer	2.86 (0.86)	3.00 (1.41)
Chance of getting skin cancer is high	3.01 (0.88)	3.07 (1.50)

Occasional Tanning vs Frequent Tanning: p = 0.02, ANOVA
Occasional Tanning vs Frequent Tanning: p = 0.001, ANOVA
Occasional Tanning vs Frequent Tanning: p = 0.34, ANOVA

Population analysed: Responses to 7 survey items using Likert scale \[1= strongly disagree (not at all concerned), 3= neither agree nor disagree, 5= strongly agree (extremely concerned)\] were entered online

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Males Who Never Deliberately Tan	0 of 442 (0%)	0 of 442 (0%)	0 of 442
Males Who Ever Deliberately Tanned	0 of 95 (0%)	0 of 95 (0%)	0 of 95

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 33067803Robinson JK, Wahood S, Stapleton JL. Motives for intentional sunlight exposure among young adult sexual minority men: appearance, relaxation and socialization in a cohort study. Br J Dermatol. 2021 Mar;184(3):563-564. doi: 10.1111/bjd.19609. Epub 2020 Nov 18. No abstract available.
Individual participant dataSharing planned: No. Since all data is deidentified, the results cannot be shared individually; however, the results may be provided to the entire cohort in a newsletter.

Related trials for Sun Sensitivity

RecruitingObservational study
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Skin Ageing, Skin
RecruitingPhase 2
Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria
Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
Not yet recruiting
Randomized Trial of a Sun Safety Intervention for Young Adults
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Active, not recruitingPhase 3
Undergraduate Skin Cancer Prevention Trial
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RecruitingObservational study
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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.

June K Robinson, MD principal investigator

Northwestern University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Sun Sensitivity, run by Northwestern University 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 4 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 5 Jan 2021. 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. 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?

Yes. Results are posted in the registry (first posted 10 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Outdoor Tanning Motives (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04404907, which also lists 1 linked publication.

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 5 Jan 2021.