Sunscreening AgentsNCT03002922
Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating (821/2016)
A study testing BAY987517 in people with Sunscreening Agents, 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 Agents
- What is being tested?
- BAY987517
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2017to 28 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 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.
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating
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 Agents
- Being tested
- BAY987517
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY987517Drug
Sunscreen formula Y65-158
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | 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)
The expert grader will determine the percentage of coverage achieved by viewing the subject's face through the Skin Scanner
Measured: At baseline, and post exercise (30 minutes)
Secondary outcomes (1)
Report of eye stinging assessed by questionnaire
Subjective assessment of eye stinging (where 0=none to 4=severe)
Measured: Up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2016 (estimated)
- Study start18 Jan 2017
- Primary completion28 Jan 2017
- Study completion28 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 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
- NCT03002922
- Sponsor's protocol ID
- 18821
- Status last verified
- Jan 2018
- First submitted
- 19 Dec 2016
- Last updated
- 26 Jan 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 26 Jan 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
- NCT03002922
- Acronym / sponsor ID
- 18821
- Conditions
- Sunscreening Agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2017 (actual)
- Primary completion
- 28 Jan 2017 (actual)
- Study completion
- 28 Jan 2017 (actual)
- First posted
- 26 Dec 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 |
|---|---|---|
| Healthy subjects | 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 (3 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.
Key exclusion criteria (2 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.
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 |
|---|---|---|
| BAY987517Sunscreen formula Y65-158 | Drug | Healthy subjects |
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)
The expert grader will determine the percentage of coverage achieved by viewing the subject's face through the Skin Scanner
1 secondary outcome
Report of eye stinging assessed by questionnaire
Time frame: Up to 30 minutes
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 26 Jan 2018.
Related trials for Sunscreening Agents
Active, not recruiting
Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions
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RecruitingPhase 4
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
Epidermis, Ultraviolet Exposure
Recruiting
A Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Participants
Post-inflammatory Hyperpigmentation, Melasma
Enrolling by invitationObservational study
Expert Consensus on Photoprotection Practices: A Delphi Study
Photoprotection, Sunscreen
Enrolling by invitation
Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics
Sunburn, Sun Damaged Skin
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 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 3 inclusion and 2 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 26 Jan 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 26 Jan 2018.