Sunscreen AgentsNCT02857478
Supervised Outdoor-Use Test to Assess the Safety of a Sunscreen C-Spray on Sport Users
A study testing BAY 987519, SPF 50, Y51-002 and BAY 987519, SPF 50, P04-147 in people with Sunscreen Agents, run by Bayer at 1 site in United States.
Trial summary
The objective of this study was to assess the safety and appropriateness of a sunscreen product for use on sport users, under supervised outdoor-use conditions. The study was conducted under the supervision of a Board-Certified Dermatologist at an outdoor, chlorinated swimming pool facility. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sunscreen Agents
- What is being tested?
- BAY 987519, SPF 50, Y51-002 and BAY 987519, SPF 50, P04-147
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2015to 28 Jun 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects, aged 18 to 65 years
- No actinic keratosis, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions
- Must not have visible erythema, blistering or peeling that would indicate recent sunburn
- Must not have asthma. Must not be undergoing therapy with system or topical corticosteroids, anti-inflammatories or antihistamine agents
- Must not be taking any medication in which exposure to the sun is contraindicated
- Must be willing to obey all rules of the test facility
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Assess the Safety of a Sunscreen Product,BAY 987519, Bayer Sponsored, CC Products
The objective of this study was to assess the safety and appropriateness of a sunscreen product for use on sport users, under supervised outdoor-use conditions. The study was conducted under the supervision of a Board-Certified Dermatologist at an outdoor, chlorinated swimming pool facility.
- Conditions
- Sunscreen Agents
- Being tested
- BAY 987519, SPF 50, Y51-002, BAY 987519, SPF 50, P04-147
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY 987519, SPF 50, Y51-002Drug
Sufficient amount to cover all exposed skin liberally two times - approximately 240 min.
BAY 987519, SPF 50, P04-147Drug
Sufficient amount to cover all exposed skin liberally two times - approximately 240 min.
| Study group | Role | What they receive |
|---|---|---|
| Safety of a Sunscreen product | Experimental | Sunscreen product safety evaluation under supervised out-door conditions on sport users. Receives: Drug: BAY 987519, SPF 50, Y51-002; Drug: BAY 987519, SPF 50, P04-147 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Erythema as graded on a 5 point scale.
Measured: approximately 24 hours
Evaluation of AEs, including eye stinging
Reported as product related or likely product related by the investigator or trained designee
Measured: approximately 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study start27 Jun 2015
- Primary completion28 Jun 2015
- Study completion28 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sunscreen AgentsStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857478
- Sponsor's protocol ID
- 18317
- Status last verified
- Dec 2018
- First submitted
- 3 Aug 2016
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess the Safety of a Sunscreen Product,BAY 987519, Bayer Sponsored, CC Products
- ClinicalTrials.gov ID
- NCT02857478
- Acronym / sponsor ID
- 18317
- Conditions
- Sunscreen Agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2015 (actual)
- Primary completion
- 28 Jun 2015 (actual)
- Study completion
- 28 Jun 2015 (actual)
- First posted
- 5 Aug 2016 (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 objective of this study was to assess the safety and appropriateness of a sunscreen product for use on sport users, under supervised outdoor-use conditions. The study was conducted under the supervision of a Board-Certified Dermatologist at an outdoor, chlorinated swimming pool facility.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Safety of a Sunscreen product | Experimental | Drug: BAY 987519, SPF 50, Y51-002, Drug: BAY 987519, SPF 50, P04-147Sunscreen product safety evaluation under supervised out-door conditions on sport users. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects, aged 18 to 65 years
- No actinic keratosis, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions
- Must not have visible erythema, blistering or peeling that would indicate recent sunburn
- Must not have asthma. Must not be undergoing therapy with system or topical corticosteroids, anti-inflammatories or antihistamine agents
- Must not be taking any medication in which exposure to the sun is contraindicated
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| BAY 987519, SPF 50, Y51-002Sufficient amount to cover all exposed skin liberally two times - approximately 240 min. | Drug | Safety of a Sunscreen product |
| BAY 987519, SPF 50, P04-147Sufficient amount to cover all exposed skin liberally two times - approximately 240 min. | Drug | Safety of a Sunscreen product |
Primary outcome
Evaluation of Erythema as graded on a 5 point scale.
Time frame: approximately 24 hours
Evaluation of AEs, including eye stinging
Time frame: approximately 24 hours
Reported as product related or likely product related by the investigator or trained designee
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 12 Dec 2018.
Related trials for Sunscreen Agents
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A Clinical Study to Evaluate the Efficacy and SPF of Two Test Materials According to an Adaptation of the Guidelines of the FDA Sunscreen Drug Products for Over-the-Counter Human Use
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Expert Consensus on Photoprotection Practices: A Delphi Study
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Evaluation of Efficacy of Anthelios Sunscreen on Face Versus Usual Routine on Signs of Aging
Aging
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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BAY 987519, SPF 50, Y51-002 and BAY 987519, SPF 50, P04-147 in people with Sunscreen Agents, run by Bayer 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 6 inclusion and 0 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 12 Dec 2018. 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?
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?
Evaluation of Erythema as graded on a 5 point scale. (time frame: approximately 24 hours). 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 12 Dec 2018.