Sun ProtectionNCT02952235
Evaluation of Sunscreens Under Actual Use Conditions
A study testing SPF50+ and SPF100+ in people with Sun Protection, run by Johnson & Johnson Consumer and Personal Products Worldwide.
Trial summary
Use of two high SPF sunscreens under actual use conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sun Protection
- What is being tested?
- SPF50+ and SPF100+
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2016to 31 Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and Females with Fitzpatrick Skin Types I-III
- At least 18 years old
- Able to read, write, speak and understand the English language.
- Has personally read, signed, and dated the Informed Consent Form (including HIPAA disclosure) and Photograph Release
- Generally in good health based on medical history reported by the subject
- Healthy male or female subjects with no history or evidence of clinically relevant medical disorder, as determined from a brief medical history interview.
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- Willing and able to follow the study instructions, including:
- Remain outdoors for at least 5 hours on Day 1 during the study with face and neck uncovered (as much as possible)
- Apply the test products (sunscreen) to designated sides of the face and neck
- Remove any make-up, sunscreen, or other facial products at baseline prior to applying test product. Use test product in place of current sun protection topical skincare products (this includes make-up)
- Attend scheduled visits and intend to successfully complete the study
- Return ALL study products at Day 2 exit visit
- Refrain from using other sunscreen products or tanning bed use during the duration of the study.
Who cannot join
- Individuals with known allergies or sensitivities to sunscreens or any ingredient contained in the test products or common topical skincare products, including adhesives.
- Observable Sunburn (erythema score above 0.5) on the face and neck as determined by the PI or designee.
- Women known to be pregnant or nursing.
- Individuals with any disease or condition of the skin (e.g., active [i.e. flaring] eczema or psoriasis, skin cancer, polymorphic light eruption (PMLE), systemic lupus erythematous (SLE), xerodermapigmentosa) that could interfere with the study or increase risk to the subject.
- Individuals with self-reported UNCONTROLLED metabolic conditions, such as diabetes, hypertension, hyper/hypothyroidism, hypercholesterolemia
- Subjects who are taking medication for chronic conditions that may make a subject more sun sensitive (e.g., Tetracyclines, antifungals, certain diuretics, etc.)
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- Skin diseases on tested sites (e.g., photosensitivity disorders, etc.), which may influence the outcome of the study
- Wearing of a full head covered ski mask.
- An individual who has any condition which in the PI's judgment makes the candidate an inappropriate subject for study participation
- Subjects who are related to those persons involved directly or indirectly with the conduct of this study (i.e., PI, sub-investigators, study coordinators, other site personnel, employees of Johnson \& Johnson subsidiaries, contractors of Johnson \& Johnson, and the families of each)
- Individuals with a condition or situation which, in the PI's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
- Individual viewed by the PI as not being able to complete the study
About this study
Official title: A Single Center, Randomized, Split-Face, Double-Blinded, Single Sun Exposure Evaluation of Sunscreens of SPF 50+ and Above Under Actual Use Conditions
Use of two high SPF sunscreens under actual use conditions.
Read the detailed description
To evaluate the difference in the level of sunburn (erythema) protection following a single period of natural sunlight exposure afforded by application of SPF 50+ and SPF 100+ sunscreens.
- Conditions
- Sun Protection
- Being tested
- SPF50+, SPF100+
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPF50+Other
Also called Sunscreens
Sun protection
SPF100+Other
Also called Sunscreens
Sun protection
| Study group | Role | What they receive |
|---|---|---|
| SPF50+ | Other | SPF 50+ assigned to Left side of face SPF 100+ assigned to Right side of face Receives: Other: SPF50+ |
| SPF100+ | Other | SPF 100+ assigned to Left side of face SPF 50+ assigned to Right side of face Receives: Other: SPF100+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side-by-side Comparison (overall difference) of Sunburn.
The side-by-side comparison utilized the following condensed two side overall difference scale: L1 = subject's left side noticeably more sunburned than right side, 0= no difference in sunburn, R1= subject's right side noticeably more sunburned than left side. The 0 outcomes were excluded from the analysis.
Measured: Day 2
Secondary outcomes (1)
Difference in Erythema Score Between Left and Right Sides at Day 2
Erythema was assessed using a scale of 0 = no burn, 1 = possible burn, not clearly defined; 2 = defined redness clearly caused by UV; 3 = severe sunburn with pronounced redness; and 4 = edema and blisters
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study start31 Mar 2016
- Primary completion31 Mar 2016
- Study completion31 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sun ProtectionStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joshua Williams, PhD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952235
- Sponsor's protocol ID
- CO-151112132858-SACT
- Status last verified
- Jun 2017
- First submitted
- 31 Oct 2016
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Split-Face, Double-Blinded, Single Sun Exposure Evaluation of Sunscreens of SPF 50+ and Above Under Actual Use Conditions
- ClinicalTrials.gov ID
- NCT02952235
- Acronym / sponsor ID
- CO-151112132858-SACT
- Conditions
- Sun Protection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2016 (actual)
- Primary completion
- 31 Mar 2016 (actual)
- Study completion
- 31 Mar 2016 (actual)
- First posted
- 2 Nov 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.
Use of two high SPF sunscreens under actual use conditions.
Detailed description
To evaluate the difference in the level of sunburn (erythema) protection following a single period of natural sunlight exposure afforded by application of SPF 50+ and SPF 100+ sunscreens.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPF50+ | Other | Other: SPF50+SPF 50+ assigned to Left side of face SPF 100+ assigned to Right side of face |
| SPF100+ | Other | Other: SPF100+SPF 100+ assigned to Left side of face SPF 50+ assigned to Right side of face |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Males and Females with Fitzpatrick Skin Types I-III
- At least 18 years old
- Able to read, write, speak and understand the English language.
- Has personally read, signed, and dated the Informed Consent Form (including HIPAA disclosure) and Photograph Release
- Generally in good health based on medical history reported by the subject
Key exclusion criteria (12 listed)
- Individuals with known allergies or sensitivities to sunscreens or any ingredient contained in the test products or common topical skincare products, including adhesives.
- Observable Sunburn (erythema score above 0.5) on the face and neck as determined by the PI or designee.
- Women known to be pregnant or nursing.
- Individuals with any disease or condition of the skin (e.g., active [i.e. flaring] eczema or psoriasis, skin cancer, polymorphic light eruption (PMLE), systemic lupus erythematous (SLE), xerodermapigmentosa) that could interfere with the study or increase risk to the subject.
- Individuals with self-reported UNCONTROLLED metabolic conditions, such as diabetes, hypertension, hyper/hypothyroidism, hypercholesterolemia
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 |
|---|---|---|
| SPF50+Also: SunscreensSun protection | Other | SPF50+ |
| SPF100+Also: SunscreensSun protection | Other | SPF100+ |
Primary outcome
Side-by-side Comparison (overall difference) of Sunburn.
Time frame: Day 2
The side-by-side comparison utilized the following condensed two side overall difference scale: L1 = subject's left side noticeably more sunburned than right side, 0= no difference in sunburn, R1= subject's right side noticeably more sunburned than left side. The 0 outcomes were excluded from the analysis.
1 secondary outcome
Difference in Erythema Score Between Left and Right Sides at Day 2
Time frame: Day 2
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 8 Jun 2017.
- Individual participant dataSharing planned: No
Related trials for Sun Protection
Active, not recruiting
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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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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.
Joshua Williams, PhD study director
Sponsor GmbH
Questions about this trial
What is this clinical trial studying?
A study testing SPF50+ and SPF100+ in people with Sun Protection, run by Johnson & Johnson Consumer and Personal Products Worldwide.
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 13 inclusion and 12 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 8 Jun 2017. 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.
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?
Side-by-side Comparison (overall difference) of Sunburn. (time frame: Day 2). 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 8 Jun 2017.