Sun ProtectionNCT03033654
Two Consecutive Sunscreen Applications Optimize Sun Protection
A study testing Sunscreen, Actinica in people with Sun Protection, run by Bispebjerg Hospital.
Trial summary
The investigators aim to investigate how much two consecutive applications of sunscreen before sun exposure can increase the quantities of sunscreen applied and decrease the skin area left without sunscreen compared to a single application. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sun Protection
- What is being tested?
- Sunscreen, Actinica
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Feb 2015
- 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
- Healthy Caucasians between older than 18
Who cannot join
- Suffering from a skin disease, were allergic to the content in sunscreen, were pregnant or breastfeeding
About this study
The investigators aim to investigate how much two consecutive applications of sunscreen before sun exposure can increase the quantities of sunscreen applied and decrease the skin area left without sunscreen compared to a single application. Volunteers wearing swimwear applied sunscreen in a laboratory environment twice and had pictures taken in black light before and after. As sunscreens absorb black light the darkness of the skin increased with increasing amounts of sunscreen applied. The investigators conducted a standard curve establishing a link between picture darkness and applied sunscreen quantity. Participants were asked to apply sunscreen the way they would normally do but two consecutive times. No other advice was given. The level of protection was determined by picture analysis as measurements of darkness of selected skin sites as well as the percentages of skin area left without sunscreen in different body regions and in total.
- Conditions
- Sun Protection
- Being tested
- Sunscreen, Actinica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunscreen, ActinicaOther
Two Consecutive Sunscreen Applications
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Two Consecutive Sunscreen Applications Receives: Other: Sunscreen, Actinica |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sun protection
Sun protection will be determined as sunscreen quantities applied in mg/cm^2 and areas of covered skin in percentage.
Measured: The day of intervention. Sun protection will be assessed right after sunscreen application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study startFeb 2015
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sun ProtectionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ida M. Heerfordt, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033654
- Sponsor's protocol ID
- H-1-2014-094
- Status last verified
- Jan 2017
- First submitted
- 20 Jan 2017
- Last updated
- 27 Jan 2017
- 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 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Consecutive Sunscreen Applications Optimize Sun Protection
- ClinicalTrials.gov ID
- NCT03033654
- Acronym / sponsor ID
- H-1-2014-094
- Conditions
- Sun Protection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 27 Jan 2017 (estimated)
- 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.
The investigators aim to investigate how much two consecutive applications of sunscreen before sun exposure can increase the quantities of sunscreen applied and decrease the skin area left without sunscreen compared to a single application. Volunteers wearing swimwear applied sunscreen in a laboratory environment twice and had pictures taken in black light before and after. As sunscreens absorb black light the darkness of the skin increased with increasing amounts of sunscreen applied. The investigators conducted a standard curve establishing a link between picture darkness and applied sunscreen quantity. Participants were asked to apply sunscreen the way they would normally do but two consecutive times. No other advice was given. The level of protection was determined by picture analysis as measurements of darkness of selected skin sites as well as the percentages of skin area left without sunscreen in different body regions and in total.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Sunscreen, ActinicaTwo Consecutive Sunscreen Applications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy Caucasians between older than 18
Key exclusion criteria (1 listed)
- Suffering from a skin disease, were allergic to the content in sunscreen, were pregnant or breastfeeding
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 |
|---|---|---|
| Sunscreen, ActinicaTwo Consecutive Sunscreen Applications | Other | Intervention |
Primary outcome
Sun protection
Time frame: The day of intervention. Sun protection will be assessed right after sunscreen application.
Sun protection will be determined as sunscreen quantities applied in mg/cm^2 and areas of covered skin in percentage.
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 27 Jan 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sunscreen, Actinica in people with Sun Protection, run by Bispebjerg Hospital.
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 1 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 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Sun protection (time frame: The day of intervention. Sun protection will be assessed right after sunscreen application.). 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 27 Jan 2017.