Sunscreening AgentNCT02831478
Outdoor-Use Test for Sunscreen Products in Children Ages 3 to 9 Years Old
A study testing BAY987517 and Sunscreen Lotion (RB# T78-190B) in people with Sunscreening Agent, run by Bayer at 1 site in United States.
Trial summary
To assess the safety of a sunscreen product under supervised outdoor-use conditions with the target consumer Read more about this study
- Who is it for?
- Ages 3 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Sunscreening Agent
- What is being tested?
- BAY987517 and Sunscreen Lotion (RB# T78-190B)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2016to 10 Jul 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 3 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subject must be healthy, males or females between 3 to 9 years of age with no medical conditions of the skin.
- Subjects must have Fitzpatrick Skin Type I, II, III or IV.
- Subjects must agree to restrict their sun exposure activities for at least five days immediately preceding participation in the study.
Who cannot join
- Subjects must not have actinic keratoses, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions.
- Subjects must not have visible erythema, blistering, or peeling that would indicate recent sunburn as determined by the baseline skin evaluation.
- Subjects must not have significantly tanned skin.
Trial locations and contacts
1 site in 1 country.
About this study
To assess the safety of a sunscreen product under supervised outdoor-use conditions with the target consumer
- Conditions
- Sunscreening Agent
- Being tested
- BAY987517, Sunscreen Lotion (RB# T78-190B)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY987517Drug
Applied liberally to the skin (Formulation: RB# Z16-071)
Sunscreen Lotion (RB# T78-190B)Drug
Applied liberally to the skin
| Study group | Role | What they receive |
|---|---|---|
| BAY987517 | Experimental | 2/3 of subjects testing the test article Receives: Drug: BAY987517 |
| Sunscreen Lotion | Active comparator | 1/3 of subjects testing the marketed control Receives: Drug: Sunscreen Lotion (RB# T78-190B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin response to sun exposure according to the Skin Evaluation Response Scale from 0 to 3
Measured: From the beginning of the study until 24 hours after study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study start9 Jul 2016
- Primary completion10 Jul 2016
- Study completion10 Jul 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- 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
- NCT02831478
- Sponsor's protocol ID
- 18533
- Status last verified
- Dec 2018
- First submitted
- 11 Jul 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
- Outdoor-Use Test for Sunscreen Products in Children Ages 3 to 9 Years Old
- ClinicalTrials.gov ID
- NCT02831478
- Acronym / sponsor ID
- 18533
- Conditions
- Sunscreening Agent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2016 (actual)
- Primary completion
- 10 Jul 2016 (actual)
- Study completion
- 10 Jul 2016 (actual)
- First posted
- 13 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 assess the safety of a sunscreen product under supervised outdoor-use conditions with the target consumer
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAY987517 | Experimental | Drug: BAY9875172/3 of subjects testing the test article |
| Sunscreen Lotion | Active comparator | Drug: Sunscreen Lotion (RB# T78-190B)1/3 of subjects testing the marketed control |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Subject must be healthy, males or females between 3 to 9 years of age with no medical conditions of the skin.
- Subjects must have Fitzpatrick Skin Type I, II, III or IV.
- Subjects must agree to restrict their sun exposure activities for at least five days immediately preceding participation in the study.
Key exclusion criteria (3 listed)
- Subjects must not have actinic keratoses, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions.
- Subjects must not have visible erythema, blistering, or peeling that would indicate recent sunburn as determined by the baseline skin evaluation.
- Subjects must not have significantly tanned skin.
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 |
|---|---|---|
| BAY987517Applied liberally to the skin (Formulation: RB# Z16-071) | Drug | BAY987517 |
| Sunscreen Lotion (RB# T78-190B)Applied liberally to the skin | Drug | Sunscreen Lotion |
Primary outcome
Skin response to sun exposure according to the Skin Evaluation Response Scale from 0 to 3
Time frame: From the beginning of the study until 24 hours after study
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.
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 and Sunscreen Lotion (RB# T78-190B) 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 3 inclusion and 3 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?
Skin response to sun exposure according to the Skin Evaluation Response Scale from 0 to 3 (time frame: From the beginning of the study until 24 hours after study). 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.