Sunscreening AgentsNCT02750475

Human Phototoxicity Test

A study testing Sunscreen Sport Lotion (BAY987516) and Untreated Skin in people with Sunscreening Agents, run by Bayer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To determine the phototoxic potential of a topically applied article in human subjects Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Sunscreening Agents
What is being tested?: Sunscreen Sport Lotion (BAY987516) and Untreated Skin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: 2 May 2016to 6 May 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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

be male or female between the ages of 18 and 60 inclusive;
be lightly pigmented (Fitzpatrick Skin Type I, II, III);
have read and signed the written Informed Consent Form and have completed a Health Insurance Portability and Accountability Act (HIPAA) Authorization Form in conformance with 45CFR Parts 160 and 164;
be in general good health as determined by the subject's medical history and in the discretion of the investigator;

Who cannot join

have a visible sunburn;
have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses;
must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product;
have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products;

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Piscataway, New Jersey, 08854

Other trials in United States

About this study

To determine the phototoxic potential of a topically applied article in human subjects

Conditions: Sunscreening Agents
Being tested: Sunscreen Sport Lotion (BAY987516), Untreated Skin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sunscreen Sport Lotion (BAY987516)Drug
50 μl/cm*2 or 0.05 gm/cm*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each). After the test articles have dried for 5 to 15 min, the sites are covered by the appropriate patch.24 hours later, the set of patches covering the product are removed. Three (3) μl/ cm2 or 0.003 gm/cm*2 of the test product is reapplied to the test site, air dried for 5 to 15 minutes for volatilization and then the test site is exposed to UVA radiation.(Formulation number - RB# Y65-110)
Untreated SkinOther
This site is patched without treatment as irradiated control

Study groups in NCT02750475
Study group	Role	What they receive
Arm 1	Experimental	All subjects are patched. Receives: Drug: Sunscreen Sport Lotion (BAY987516); Other: Untreated Skin

What is being measured

The primary outcome is the main question the study is designed to answer.

Intensity of skin reactions will be evaluated using the 5 point grading scale
Measured: Up to 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 May 20166 May 2016

First posted25 Apr 2016 (estimated)
Study start2 May 2016
Primary completion6 May 2016
Study completion6 May 2016

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: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02750475
Sponsor's protocol ID: 18851
Status last verified: Dec 2018
First submitted: 21 Apr 2016
Last updated: 13 Dec 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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
Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions
Melanoma (Skin Cancer)
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

All Sunscreening Agents trials

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: Human Phototoxicity Test
ClinicalTrials.gov ID: NCT02750475
Acronym / sponsor ID: 18851
Conditions: Sunscreening Agents
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: 2 May 2016 (actual)
Primary completion: 6 May 2016 (actual)
Study completion: 6 May 2016 (actual)
First posted: 25 Apr 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 determine the phototoxic potential of a topically applied article in human subjects

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Arm 1	Experimental	Drug: Sunscreen Sport Lotion (BAY987516), Other: Untreated SkinAll subjects are patched.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

be male or female between the ages of 18 and 60 inclusive;
be lightly pigmented (Fitzpatrick Skin Type I, II, III);
have read and signed the written Informed Consent Form and have completed a Health Insurance Portability and Accountability Act (HIPAA) Authorization Form in conformance with 45CFR Parts 160 and 164;
be in general good health as determined by the subject's medical history and in the discretion of the investigator;

Key exclusion criteria (4 listed)

have a visible sunburn;
have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses;
must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product;
have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products;

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
Sunscreen Sport Lotion (BAY987516)50 μl/cm2 or 0.05 gm/cm2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each). After the test articles have dried for 5 to 15 min, the sites are covered by the appropriate patch.24 hours later, the set of patches covering the product are removed. Three (3) μl/ cm2 or 0.003 gm/cm*2 of the test product is reapplied to the test site, air dried for 5 to 15 minutes for volatilization and then the test site is exposed to UVA radiation.(Formulation number - RB# Y65-110)	Drug	Arm 1
Untreated SkinThis site is patched without treatment as irradiated control	Other	Arm 1

Primary outcome

Intensity of skin reactions will be evaluated using the 5 point grading scale
Time frame: Up to 48 hours

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 Agents

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
Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions
Melanoma (Skin Cancer)
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 Sunscreen Sport Lotion (BAY987516) and Untreated Skin 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 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?

Intensity of skin reactions will be evaluated using the 5 point grading scale (time frame: Up to 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02750475.

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.