Sunscreening AgentsNCT03012347
Evaluation of a Gel Sunscreen in Controlled Use Conditions (208/2016)
A study testing BAY987517 and BullFrog Gel Sunscreen Land Sport SPF-50 in people with Sunscreening Agents, run by Bayer at 1 site in United States.
Trial summary
To explore and quantify potential issues with application of a gel sunscreen in Outdoor Use testing, in a controlled indoor environment Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sunscreening Agents
- What is being tested?
- BAY987517 and BullFrog Gel Sunscreen Land Sport SPF-50
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2017to 19 Jan 2017
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects may be male or female.
- Subjects must be adults between 18 and 45 years of age.
- Subjects must have and have had a consistently active lifestyle for at least the previous few years (exercise
- outdoors and in direct sun exposure at least 2 times per week for at least 30 minutes-acceptable activities include tennis, running, jogging, walking, golf, etc.), i.e., outdoor activity should not be a new behavior.
- Subjects must have used a sunscreen with SPF 50 or higher within the previous 9 months.
Who cannot join
- Subjects who have received or used an Investigational New Drug within the last 30 days.
- Subjects who have been active participants in another clinical or subjective product performance study within the last 30 days.
- Subjects who have a known allergy or sensitivity to sunscreen ingredients or test materials.
- Subjects with respiratory allergies or asthma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Gel Sunscreen in Controlled Use Conditions
To explore and quantify potential issues with application of a gel sunscreen in Outdoor Use testing, in a controlled indoor environment
- Conditions
- Sunscreening Agents
- Being tested
- BAY987517, BullFrog Gel Sunscreen Land Sport SPF-50
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY987517Drug
Subjects will be instructed to apply the test article in a split-body and face configuration, to the assigned side of the body (face, arms, torso, and legs), as they normally would before going outdoors for a run, walk or other sport related activity. (Formulation: RB# Y73-161)
BullFrog Gel Sunscreen Land Sport SPF-50Drug
Subjects will be instructed to apply the test article in a split-body and face configuration, to the assigned side of the body (face, arms, torso, and legs), as they normally would before going outdoors for a run, walk or other sport related activity.
| Study group | Role | What they receive |
|---|---|---|
| Sunscreen Users | Experimental | Subjects will participate in a 2-Day study involving three applications of a single test article each day. The first application will be followed by an exposure of 30 minutes in a hot room. Receives: Drug: BAY987517; Drug: BullFrog Gel Sunscreen Land Sport SPF-50 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feeling any discomfort after applying the product assessed by questionnaire
Measured: 15 minutes after each application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study start5 Jan 2017
- Primary completion19 Jan 2017
- Study completion19 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sunscreening 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
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012347
- Sponsor's protocol ID
- 19208
- Status last verified
- Dec 2017
- First submitted
- 4 Jan 2017
- Last updated
- 7 Dec 2017
- 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 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Gel Sunscreen in Controlled Use Conditions
- ClinicalTrials.gov ID
- NCT03012347
- Acronym / sponsor ID
- 19208
- Conditions
- Sunscreening Agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2017 (actual)
- Primary completion
- 19 Jan 2017 (actual)
- Study completion
- 19 Jan 2017 (actual)
- First posted
- 6 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.
To explore and quantify potential issues with application of a gel sunscreen in Outdoor Use testing, in a controlled indoor environment
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sunscreen Users | Experimental | Drug: BAY987517, Drug: BullFrog Gel Sunscreen Land Sport SPF-50Subjects will participate in a 2-Day study involving three applications of a single test article each day. The first application will be followed by an exposure of 30 minutes in a hot room. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects may be male or female.
- Subjects must be adults between 18 and 45 years of age.
- Subjects must have and have had a consistently active lifestyle for at least the previous few years (exercise
- outdoors and in direct sun exposure at least 2 times per week for at least 30 minutes-acceptable activities include tennis, running, jogging, walking, golf, etc.), i.e., outdoor activity should not be a new behavior.
- Subjects must have used a sunscreen with SPF 50 or higher within the previous 9 months.
Key exclusion criteria (4 listed)
- Subjects who have received or used an Investigational New Drug within the last 30 days.
- Subjects who have been active participants in another clinical or subjective product performance study within the last 30 days.
- Subjects who have a known allergy or sensitivity to sunscreen ingredients or test materials.
- Subjects with respiratory allergies or asthma.
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 |
|---|---|---|
| BAY987517Subjects will be instructed to apply the test article in a split-body and face configuration, to the assigned side of the body (face, arms, torso, and legs), as they normally would before going outdoors for a run, walk or other sport related activity. (Formulation: RB# Y73-161) | Drug | Sunscreen Users |
| BullFrog Gel Sunscreen Land Sport SPF-50Subjects will be instructed to apply the test article in a split-body and face configuration, to the assigned side of the body (face, arms, torso, and legs), as they normally would before going outdoors for a run, walk or other sport related activity. | Drug | Sunscreen Users |
Primary outcome
Feeling any discomfort after applying the product assessed by questionnaire
Time frame: 15 minutes after each application
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 7 Dec 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BAY987517 and BullFrog Gel Sunscreen Land Sport SPF-50 in people with Sunscreening 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 5 inclusion and 4 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 7 Dec 2017. 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?
Feeling any discomfort after applying the product assessed by questionnaire (time frame: 15 minutes after each 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 7 Dec 2017.