Sunscreening AgentNCT02842268
Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating
A study testing BAY987517 in people with Sunscreening Agent, run by Bayer at 1 site in United States.
Trial summary
To visually evaluate the retention of coverage of the Test Product(s) (TP) on the face after exercise compared to the full coverage observed prior to exercise. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Sunscreening Agent
- What is being tested?
- BAY987517
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2016to 22 Jun 2016
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects may be male or female, of an age of 18-55 years inclusive.
- Subjects must be capable of understanding and providing written informed consent.
- Subjects must sign a written confidentiality agreement including a photography release form.
- Subjects must be in good general health as judged by a specified licensed physician, who will indicate their suitability to participate in this study.
- Female subjects must be willing to take a rapid screen pregnancy test prior to each exercise session.
- Subjects must be willing to follow study instructions as set forth in the protocol.
- Subjects must not have facial piercing(s).
- Subjects must be Fitzpatrick Skin Type I, II, or III.
Who cannot join
- Subjects must not have received or used an Investigational New Drug within the last 30 days.
- Subjects must not have been active participants in another clinical or subjective TP performance study within the last 30 days unless authorized by this Sponsor.
- Subjects must not have a known physical or medical condition that would preclude vigorous exercise
- Subjects must not have a five-minute resting pulse rate greater than 80 bpm.
- Subjects must not take any chronic medication other than vitamins, hormone replacement therapy, low-dose aspirin, or oral contraceptives.
- Subjects must not have applied prescription or over-the-counter medicines to their face at least 96 hours prior to exercise session
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- Subjects must not have a known allergy or sensitivity to sunscreen products or Cetaphil cleanser.
- Female subjects must not be pregnant (self-reported) or test positive using an on-site pregnancy test.
- Female subjects must not be nursing a child.
- Subjects must not have smoked cigarettes, pipes, or cigars in the last 60 days.
- Subjects who in the judgment of the Investigator have any condition that would make study participation inappropriate.
- Subjects must not be a member or relative of the clinical trial staff or the Sponsor directly involved in the study.
Trial locations and contacts
1 site in 1 country.
About this study
To visually evaluate the retention of coverage of the Test Product(s) (TP) on the face after exercise compared to the full coverage observed prior to exercise.
- Conditions
- Sunscreening Agent
- Being tested
- BAY987517
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY987517Drug
Test product dried for at least 15 minutes.Subjects to ride for 30 minutes on a stationary bicycle.(Formulation Number :Y73-161)
| Study group | Role | What they receive |
|---|---|---|
| BAY987517 | Experimental | Subject will self-apply the test sunscreen formula to his/her face with the goal of applying 0.65 to 0.85 grams.Subject should sweat profusely. Receives: Drug: BAY987517 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of face coverage post exercise compared to the full coverage observed prior to exercise (in percent).
Done with a Skin Scanner( before and after each exercise session) using the 11-point scale
Measured: At baseline and post exercise (30 minutes)
Secondary outcomes (1)
Eye Stinging on grading scale
On scale:0 = None,1 = Slight,2 = Mild,3 = Moderate, 4 = Severe
Measured: Up to 30 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study start17 Jun 2016
- Primary completion22 Jun 2016
- Study completion22 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sunscreening AgentStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT02842268
- Sponsor's protocol ID
- 18818
- Status last verified
- Dec 2018
- First submitted
- 20 Jun 2016
- Last updated
- 13 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 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating
- ClinicalTrials.gov ID
- NCT02842268
- Acronym / sponsor ID
- 18818
- Conditions
- Sunscreening Agent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2016 (actual)
- Primary completion
- 22 Jun 2016 (actual)
- Study completion
- 22 Jun 2016 (actual)
- First posted
- 22 Jul 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.
To visually evaluate the retention of coverage of the Test Product(s) (TP) on the face after exercise compared to the full coverage observed prior to exercise.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAY987517 | Experimental | Drug: BAY987517Subject will self-apply the test sunscreen formula to his/her face with the goal of applying 0.65 to 0.85 grams.Subject should sweat profusely. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subjects may be male or female, of an age of 18-55 years inclusive.
- Subjects must be capable of understanding and providing written informed consent.
- Subjects must sign a written confidentiality agreement including a photography release form.
- Subjects must be in good general health as judged by a specified licensed physician, who will indicate their suitability to participate in this study.
- Female subjects must be willing to take a rapid screen pregnancy test prior to each exercise session.
Key exclusion criteria (12 listed)
- Subjects must not have received or used an Investigational New Drug within the last 30 days.
- Subjects must not have been active participants in another clinical or subjective TP performance study within the last 30 days unless authorized by this Sponsor.
- Subjects must not have a known physical or medical condition that would preclude vigorous exercise
- Subjects must not have a five-minute resting pulse rate greater than 80 bpm.
- Subjects must not take any chronic medication other than vitamins, hormone replacement therapy, low-dose aspirin, or oral contraceptives.
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 |
|---|---|---|
| BAY987517Test product dried for at least 15 minutes.Subjects to ride for 30 minutes on a stationary bicycle.(Formulation Number :Y73-161) | Drug | BAY987517 |
Primary outcome
Change of face coverage post exercise compared to the full coverage observed prior to exercise (in percent).
Time frame: At baseline and post exercise (30 minutes)
Done with a Skin Scanner( before and after each exercise session) using the 11-point scale
1 secondary outcome
Eye Stinging on grading scale
Time frame: Up to 30 mins
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 13 Dec 2018.
Related trials for Sunscreening Agent
Active, not recruiting
Impact of Sunscreen Dispensers in Parks Visited by Teenagers
Skin Neoplasm, Adolescent Behavior
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 BAY987517 in people with Sunscreening Agent, 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 8 inclusion and 12 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 13 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?
Change of face coverage post exercise compared to the full coverage observed prior to exercise (in percent). (time frame: At baseline and post exercise (30 minutes)). 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 13 Dec 2018; AzTrials last refreshed its copy on 7 Nov 2026.