Sun ProtectionPhase 3PFA and SPFNCT01001975

Determination of Sun Protection in Sunscreen Formulas (Study SR09-15)(P08236)(COMPLETED)

A Phase 3 study testing Sunscreen Test Code: V53-028, Sunscreen Test Code: V53-030 and Standard SPF 4 Sunscreen in people with Sun Protection, run by Bayer.

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

Study to determine the sunscreen protection factor (SPF) and ultraviolet A protection factor (PFA) of 2 sunscreen products containing the combination of zinc oxide and avobenzone with and without ensulizole. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Sun Protection
What is being tested?: Sunscreen Test Code: V53-028, Sunscreen Test Code: V53-030 and Standard SPF 4 Sunscreen
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: No sites listed yet
Study dates: Jul 2009to Aug 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

18 to 70 years of age
Have Fitzpatrick skin types I, II, or III
In good general health based on a medical history review
Be free of any acute or chronic illness/disease that might interfere with or increase risk of study participation
Be able to cooperate with the investigator and research staff
Be willing to have the test materials applied according to the protocol
Be capable of understanding and provide written informed consent

Who cannot join

Subjects with a history of adverse effects upon sun exposure
Subjects currently taking any medication that may alter the sunlight response or is a known photosensitizer
Subjects with a history of any form of cancer, lupus, psoriasis, rosacea, porphyria cutanea tarda, connective tissue disease, diabetes or any disease that would increase the risks associated with study participation
Subjects with an abnormal sensitivity to any sunscreen agent
Females who indicate that they are pregnant or nursing an infant during the period of the study
Subjects with excessive hair, blemishes, nevi, warts, moles, scars, sunburn, suntan or uneven pigmentation in the test areas

Show all 9Show fewer

Subjects who have been administered an investigations drug or have participated in another SPF or PFA study within 30 days prior to this study
Subjects who are allergic to latex or latex products
Subjects who have any conditions that would make study participation inappropriate as determined by the investigator

About this study

Official title: Determination of Sun Protection Factors (PFA and SPF) in Sunscreen Formulas Containing Combinations of Zinc Oxide and Avobenzone

Conditions: Sun Protection
Being tested: Sunscreen Test Code: V53-028, Sunscreen Test Code: V53-030, Standard SPF 4 Sunscreen
Keywords: Sunscreens

What participants receive

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

Sunscreen Test Code: V53-028Drug
Sunscreen formula containing 15% Zinc Oxide, 3% Avobenzone, and 1% Ensulizole
Sunscreen Test Code: V53-030Drug
Sunscreen formula containing 15% Zinc Oxide and 3% Avobenzone
Standard SPF 4 SunscreenDrug
8% Homosalate Standard SPF 4 Sunscreen

Study groups in NCT01001975
Study group	Role	What they receive
SPF Testing	Experimental	Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet B radiation [UVB] and UVA). Receives: Drug: Sunscreen Test Code: V53-028; Drug: Sunscreen Test Code: V53-030; Drug: Standard SPF 4 Sunscreen
UVA Protection Testing	Experimental	Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure. Receives: Drug: Sunscreen Test Code: V53-028; Drug: Sunscreen Test Code: V53-030

What is being measured

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

Determination of Sunscreen Protection Factor (SPF)
Test material (V53-028 and V53-030) and control test material (8% Homoslate SPF 4) were applied to test area. Following exposure to a series of Ultraviolet light exposures, SPF scores were recorded at 16 to 24 hours post-exposure, to determine the Minimal Erythema Dose (MED) of protected and unprotected skin. SPF was calculated as the MED of protected skin divided by the MED of unprotected skin. Expected SPF 15 is a score on a scale; range 11.34 (worst) to 19.83 (best).
Measured: 16 to 24 hours post-exposure
Determination of Ultraviolet A Protection Factor (PFA)
Test materials (V53-028 and V53-030) were applied to test area. Following a series of Ultraviolet radiation A (UVA) exposures, scores were recorded at 2 and 4 hours post-exposure, to determine the Minimal Persistent Pigment-Darkening Dose (MPPD) of protected and unprotected skin. PFA was calculated as the MPPD of protected skin divided by the MPPD of unprotected skin. Expected PFA is a score on a scale; range 6.40 (worst) to 15.62 (best).
Measured: 2 to 4 hours post-exposure

Timeline

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

Jul 2009Aug 2009

First posted27 Oct 2009 (estimated)
Study startJul 2009
Primary completionAug 2009
Study completionAug 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Sun ProtectionStudies 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 3
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01001975
Sponsor's protocol ID: 18119
Other IDs: SR09-15, P08236
Acronym: PFA and SPF
Status last verified: Feb 2015
First submitted: 23 Oct 2009
Last updated: 11 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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?

Official record

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Mobile Sun Health Intervention EnabLing Daily Protection
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Randomized Trial of a Sun Safety Intervention for Young Adults
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Effect of Gamified Sun Protection Education Provided to Chemotherapy Patients
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All Sun Protection trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Determination of Sun Protection Factors (PFA and SPF) in Sunscreen Formulas Containing Combinations of Zinc Oxide and Avobenzone
ClinicalTrials.gov ID: NCT01001975
Acronym / sponsor ID: PFA and SPF / 18119
Conditions: Sun Protection
Keywords: Sunscreens
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: Jul 2009
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 27 Oct 2009 (estimated)
Results: Posted 7 Dec 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
SPF Testing	Experimental	Drug: Sunscreen Test Code: V53-028, Drug: Sunscreen Test Code: V53-030, Drug: Standard SPF 4 SunscreenFollowing Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet B radiation [UVB] and UVA).
UVA Protection Testing	Experimental	Drug: Sunscreen Test Code: V53-028, Drug: Sunscreen Test Code: V53-030Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

18 to 70 years of age
Have Fitzpatrick skin types I, II, or III
In good general health based on a medical history review
Be free of any acute or chronic illness/disease that might interfere with or increase risk of study participation
Be able to cooperate with the investigator and research staff

Key exclusion criteria (9 listed)

Subjects with a history of adverse effects upon sun exposure
Subjects currently taking any medication that may alter the sunlight response or is a known photosensitizer
Subjects with a history of any form of cancer, lupus, psoriasis, rosacea, porphyria cutanea tarda, connective tissue disease, diabetes or any disease that would increase the risks associated with study participation
Subjects with an abnormal sensitivity to any sunscreen agent
Females who indicate that they are pregnant or nursing an infant during the period of the study

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 Test Code: V53-028Sunscreen formula containing 15% Zinc Oxide, 3% Avobenzone, and 1% Ensulizole	Drug	SPF Testing, UVA Protection Testing
Sunscreen Test Code: V53-030Sunscreen formula containing 15% Zinc Oxide and 3% Avobenzone	Drug	SPF Testing, UVA Protection Testing
Standard SPF 4 Sunscreen8% Homosalate Standard SPF 4 Sunscreen	Drug	SPF Testing

Primary outcome

Determination of Sunscreen Protection Factor (SPF)
Time frame: 16 to 24 hours post-exposure
Test material (V53-028 and V53-030) and control test material (8% Homoslate SPF 4) were applied to test area. Following exposure to a series of Ultraviolet light exposures, SPF scores were recorded at 16 to 24 hours post-exposure, to determine the Minimal Erythema Dose (MED) of protected and unprotected skin. SPF was calculated as the MED of protected skin divided by the MED of unprotected skin. Expected SPF 15 is a score on a scale; range 11.34 (worst) to 19.83 (best).
Determination of Ultraviolet A Protection Factor (PFA)
Time frame: 2 to 4 hours post-exposure
Test materials (V53-028 and V53-030) were applied to test area. Following a series of Ultraviolet radiation A (UVA) exposures, scores were recorded at 2 and 4 hours post-exposure, to determine the Minimal Persistent Pigment-Darkening Dose (MPPD) of protected and unprotected skin. PFA was calculated as the MPPD of protected skin divided by the MPPD of unprotected skin. Expected PFA is a score on a scale; range 6.40 (worst) to 15.62 (best).

Results and safety

Results posted to the registry on 7 Dec 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sun Protection Factor (SPF) Testing	5	5
UVA Protection Testing	5	5

Primary outcome: Determination of Sunscreen Protection Factor (SPF)

Time frame: 16 to 24 hours post-exposure. Mean (Standard Deviation). Unit: Score on a scale

Measure	Sun Protection Factor (SPF) Testing n = 5	UVA Protection Testing n = 0
V53-028	14.72 (2.31)	–
V53-030	15.00 (0.00)	–

Population analysed: Only subjects from the SPF Testing group had V53-028 and V53-030 applied for the determination of SPF

Primary outcome: Determination of Ultraviolet A Protection Factor (PFA)

Time frame: 2 to 4 hours post-exposure. Mean (Standard Deviation). Unit: Score on a scale

Measure	Sun Protection Factor (SPF) Testing n = 0	UVA Protection Testing n = 5
V53-028	–	11.60 (2.01)
V53-030	–	10.50 (1.12)

Population analysed: Only subjects from the UVA Protection Testing group had V53-028 and V53-030 applied for the determination of PFA

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sun Protection Factor (SPF) Testing	0 of 5 (0%)	0 of 5 (0%)	Not reported
UVA Protection Testing	0 of 5 (0%)	0 of 5 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Sun Protection

Active, not recruiting
Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions
Melanoma (Skin Cancer)
Active, not recruiting
Cancer Prevention for Young Rural Adults
Cancer
Recruiting
Mobile Sun Health Intervention EnabLing Daily Protection
Skin Cancer
Not yet recruiting
Randomized Trial of a Sun Safety Intervention for Young Adults
Sunburn
Not yet recruiting
Effect of Gamified Sun Protection Education Provided to Chemotherapy Patients
Chemotherapy, Sun Protection

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sunscreen Test Code: V53-028, Sunscreen Test Code: V53-030 and Standard SPF 4 Sunscreen in people with Sun Protection, run by Bayer.

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 7 inclusion and 9 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 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Determination of Sunscreen Protection Factor (SPF) (time frame: 16 to 24 hours post-exposure). The study lists 2 primary outcomes in all. 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 NCT01001975.

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 11 Mar 2015.