Sunscreening AgentsNCT02779270
Test the Outdoor Usage for Sunscreen Products in Female Adults
A study testing BAY987518 in people with Sunscreening Agents, run by Bayer at 1 site in United States.
Trial summary
To assess the safety of a sunscreen product when used outdoor. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sunscreening Agents
- What is being tested?
- BAY987518
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2015to 27 Sep 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be healthy, fair skinned females between the ages of 18 to 65 years with no medical conditions of the skin.
- Subjects must have Fitzpatrick Skin Types I, II, III, or IV.
- Subjects must agree to restrict their sun exposure activities for at least five days.
- Subjects must be willing and physically able to spend approximately 3 continous hours in the sun.
Who cannot join
- Subjects must not have actinic keratoses, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions as determined by the dermatological medical history.
- Subjects must not have visible erythema, blistering, or peeling that would indicate recent sunburn.
- Subjects must not have significantly tanned skin.
- Subjects must not have received any phototoxic agent or any medication to which they have a known sensitivity or allergy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supervised Outdoor -Use Test for Sunscreen Products in Female Adults
To assess the safety of a sunscreen product when used outdoor.
- Conditions
- Sunscreening Agents
- Being tested
- BAY987518, Sunscreen Lotion (U77-030 Control)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY987518Drug
Apply the assigned test product to all sun-exposed areas of the face and body while avoiding contact with mouth, eyes and eyelids.
Formulation: V27-104
Sunscreen Lotion (U77-030 Control)Drug
Apply the assigned test product to all sun-exposed areas of the face and body while avoiding contact with mouth, eyes and eyelids.
| Study group | Role | What they receive |
|---|---|---|
| BAY987518 | Experimental | Subject will apply the test product to all sun exposed areas of face and body, wait for 15 minutes, then sunbathe for 30 minutes, exercise for 20 minutes, and then sunbathe for additional 30 minutes. Immediately after the second sunbathing, enter the pool and remain in the water for 20 minutes. Then repeat the sun and water exposure activities again. Receives: Drug: BAY987518 |
| Sunscreen control | Active comparator | Subject will apply the test product to all sun exposed areas of face and body, wait for 15 minutes, then sunbathe for 30 minutes, exercise for 20 minutes, and then sunbathe for additional 30 minutes. Immediately after the second sunbathing, enter the pool and remain in the water for 20 minutes. Then repeat the sun and water exposure activities again. Receives: Drug: Sunscreen Lotion (U77-030 Control) |
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: After approximately three hours direct sun-exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study start26 Sep 2015
- Primary completion27 Sep 2015
- Study completion27 Sep 2015
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 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
- NCT02779270
- Sponsor's protocol ID
- 18318
- Status last verified
- Dec 2018
- First submitted
- 18 May 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
- Supervised Outdoor -Use Test for Sunscreen Products in Female Adults
- ClinicalTrials.gov ID
- NCT02779270
- Acronym / sponsor ID
- 18318
- Conditions
- Sunscreening Agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2015 (actual)
- Primary completion
- 27 Sep 2015 (actual)
- Study completion
- 27 Sep 2015 (actual)
- First posted
- 20 May 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 when used outdoor.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAY987518 | Experimental | Drug: BAY987518Subject will apply the test product to all sun exposed areas of face and body, wait for 15 minutes, then sunbathe for 30 minutes, exercise for 20 minutes, and then sunbathe for additional 30 minutes. Immediately after the second sunbathing, enter the pool and remain in the water for 20 minutes. Then repeat the sun and water exposure activities again. |
| Sunscreen control | Active comparator | Drug: Sunscreen Lotion (U77-030 Control)Subject will apply the test product to all sun exposed areas of face and body, wait for 15 minutes, then sunbathe for 30 minutes, exercise for 20 minutes, and then sunbathe for additional 30 minutes. Immediately after the second sunbathing, enter the pool and remain in the water for 20 minutes. Then repeat the sun and water exposure activities again. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must be healthy, fair skinned females between the ages of 18 to 65 years with no medical conditions of the skin.
- Subjects must have Fitzpatrick Skin Types I, II, III, or IV.
- Subjects must agree to restrict their sun exposure activities for at least five days.
- Subjects must be willing and physically able to spend approximately 3 continous hours in the sun.
Key exclusion criteria (4 listed)
- Subjects must not have actinic keratoses, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions as determined by the dermatological medical history.
- Subjects must not have visible erythema, blistering, or peeling that would indicate recent sunburn.
- Subjects must not have significantly tanned skin.
- Subjects must not have received any phototoxic agent or any medication to which they have a known sensitivity or allergy.
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 |
|---|---|---|
| BAY987518Apply the assigned test product to all sun-exposed areas of the face and body while avoiding contact with mouth, eyes and eyelids. Formulation: V27-104 | Drug | BAY987518 |
| Sunscreen Lotion (U77-030 Control)Apply the assigned test product to all sun-exposed areas of the face and body while avoiding contact with mouth, eyes and eyelids. | Drug | Sunscreen control |
Primary outcome
Skin response to sun exposure according to the Skin Evaluation Response Scale from 0 to 3
Time frame: After approximately three hours direct sun-exposure
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 Sunscreening Agents
Active, not recruiting
Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions
Melanoma (Skin Cancer)
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 BAY987518 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 4 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 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: After approximately three hours direct sun-exposure). 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.