SunscreenNCT05565625
A Study to Evaluate the Whitening Effect of Mineral Sunscreens in Multi-Cultural Skin Tones
A study testing Sunscreen A, Sunscreen B and Sunscreen C in people with Sunscreen, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the whitening potential effect of different mineral sunscreens across multi-cultural skin tones through instrumentation, imaging, and self-assessment and also evaluate the relationship between self-perception and objective measurement of whitening. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sunscreen
- What is being tested?
- Sunscreen A, Sunscreen B and Sunscreen C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2021to 30 Mar 2022
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Self-reported natural skin tone/skin color, targeting the following: skin tones "Pale/fair to light white" and "White to light beige" (n = 30 participants), skin tones "Beige to light tan/light olive" and "Medium tan/medium olive to light brown" (n = 30 participants), and Skin tones "Medium brown to dark brown" and "darkest brown to darkest black" (n = 30 participants)
- Has a history of using or is a current user of sunscreens
- Generally, in good health based on medical history reported by the participants
- Able to read, write, speak, and understand English
- Individual has signed the consent for photograph release and informed consent document (ICD) including Health Insurance Portability and Accountability Act (HIPAA) disclosure
- Intends to complete the study and is willing and able to follow all study instructions
Who cannot join
- Has known allergies or adverse reactions to common topical skincare products or ingredients in the ISMs
- Presents with a skin condition on the face, volar forearms, or lower legs that may confound the study results (example, psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, or active skin cancer) or interfere with evaluations (example, excessive hair, tattoos, scarring, very uneven skin tone, sunburn, scratches/broken/compromised skin)
- Has shaved or used any hair removal method on lower legs or volar forearms within 24 hours of Visit 1
- Has a history of a confirmed or suspected coronavirus disease 2019 (COVID-19) infection within 30 days prior to the study visit
- Within 14 days prior to Visit 1, has been in close contact (exposure within 6 feet for a cumulative time of 15 minutes or more over a 24-hour period) with anyone who has been infected with COVID-19
- Is under a COVID-19 isolation/quarantine order
Show all 13Show fewer
- Has experienced any of the following self-reported symptoms of COVID-19 within 2 weeks prior to the study visit: unexplained cough, shortness of breath/difficulty breathing, fatigue, body aches (headaches, muscle pain, stomachaches), conjunctivitis, loss of smell, loss of taste, poor appetite, nausea, vomiting, diarrhea, palpitations, or chest pain/tightness; temperature greater than or equal to (>=) 37.5 degrees celsius (C)/99.5 degrees fahrenheit (F), measured; use of fever or pain reducers within 2 days prior to the study visit
- Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication
- Is taking a medication that would mask an adverse event (AE) or confound the study results, including: Immunosuppressive or steroidal drugs within 2 months before Visit 1; non-steroidal anti-inflammatory drugs within 5 days before Visit 1; antihistamines within 1 week before Visit 1
- Is self-reported to be pregnant or planning to become pregnant during the study
- Has a history of or a concurrent health/other condition/situation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study
- Is simultaneously participating in any other clinical study or has participated in any product-use study within 14 days prior to Visit 1
- Is an employee/contractor or immediate family member of the principle investigator (PI), study site, or sponsor
Trial locations and contacts
1 site in 1 country.
United States1 site
Validated Claim Support (VCS)
Teaneck, New Jersey, 07666
About this study
Official title: A Single-Center, Clinical Study to Evaluate the Whitening Effect of Mineral Sunscreens in Multi-Cultural Skin Tones Thru Instrumentation Measurements, Imaging, and Self-Assessments
The purpose of this study is to evaluate the whitening potential effect of different mineral sunscreens across multi-cultural skin tones through instrumentation, imaging, and self-assessment and also evaluate the relationship between self-perception and objective measurement of whitening.
- Conditions
- Sunscreen
- Being tested
- Sunscreen A, Sunscreen B, Sunscreen C, Sunscreen D, Sunscreen E
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunscreen AOther
Participants will topically apply Sunscreen A at Visit 1.
Sunscreen BOther
Participants will apply Sunscreen B at Visit 1.
Sunscreen COther
Participants will apply Sunscreen C at Visit 1.
Sunscreen DOther
Participants will apply Sunscreen D at Visit 1.
Sunscreen EOther
Participants will apply Sunscreen E at Visit 1.
Sunscreen FOther
Participants will apply Sunscreen F at Visit 1.
| Study group | Role | What they receive |
|---|---|---|
| Sunscreen | Experimental | Participants will receive two of six sunscreens (A, B, C, D, E, and F) at Visit 1 (Day 1) to apply to whole lower legs (1 sunscreen per lower leg), between the knee and ankle. Participant will then select one of the two sunscreens randomly assigned to lower legs and apply the selected sunscreen to full face. After lower legs and facial applications are completed, a trained designee will delineate six 4 centimeters (cm)*4 cm test sites on the participants' volar forearms (3 test sites per volar forearm). The six sunscreens will be randomly assigned to the six test sites at a dose of 2.00 +- 0.05 milligrams per centimeter square (mg/cm^2) using a 1cc tuberculin syringe (without a needle) and a clean finger cot for approximately 20 to 50 seconds and applied by a trained designee. Receives: Other: Sunscreen A; Other: Sunscreen B; Other: Sunscreen C; Other: Sunscreen D; Other: Sunscreen E; Other: Sunscreen F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whitening Potential of Mineral Sunscreens Across Multi-cultural Skin Tones Through Instrumentation
Whitening potential of mineral sunscreens across multi-cultural skin tones through instrumentation (SkinSkan measurements) will be reported. SkinSkan is a non-invasive diagnostic tool that uses an optical fiber probe to collect the fluorescence signal from skin after excitation light is delivered through the same fiber probe.
Measured: Visit 1 (Day 1)
Whitening Potential of Mineral Sunscreens Across Multi-cultural Skin Tones Through Imaging
Whitening potential of mineral sunscreens across multi-cultural skin tones through imaging (facial and vocal forearms) will be reported. Image analysis will be done by using the Matlab software. A small region of interest (ROI) will be defined on the gray standard, and five regions on the face (forehead, nose, chin, left cheek, and right cheek) and the test regions on the volar forearms. The average RGB (red, green, and blue) values from these ROI will be extracted from the images. The RGB values from the gray standard will be used to calculate the correction factors per image based on the gray standard's target RGB values. Matlab will be used to convert the corrected RGB values to the LAB values. Skin whitening defined as the change in L* values pre and post product application. L* value is defined as lightness in LAB color space. High L* value corresponds to whiter color while low L* value corresponds to blacker color.
Measured: Visit 1 (Day 1)
Whitening Potential of Mineral Sunscreens Across Multi-cultural Skin Tones Through Self-assessment
Whitening potential of mineral sunscreens across multi-cultural skin tones through self-assessment will be reported via self-assessment questionnaire (Part B). This questionnaire rank whitening potential after application of the sunscreen product to the designated test areas on both inner forearms in order of least whitening (1) to most whitening (6).
Measured: Visit 1 (Day 1)
Relationship Between Self-assessment and Instrumentation
Relationship between self-assessment and instrumentation (sunscreen product) will be reported via self-assessment questionnaire (Part A) which include the question about 'how much did you like or dislike the appearance of the sunscreen product on your skin' rated on a 5-point likert scale where 1 indicates "disliked it very much", 2 indicates "disliked it somewhat", 3 indicates "neither liked or disliked it", 4 indicates "liked it somewhat" and 5 indicates "liked it very much".
Measured: Visit 1 (Day 1)
Secondary outcomes (2)
Rate of Usage Versus Whitening Effect from a Sunscreen
Whitening effect from a sunscreen that impacts participant application behavior and ultimately their sun protection will be reported. This is being determined by correlation of the self-application dosage (milligrams per centimeter square [mg/cm^2]) per treatment area versus measured whitening effect (delta L*).
Measured: Visit 1 (Day 1)
Skin Reflectance Before and After Sunscreen Applications as Assessed by SkinSkan Instrument
Skin reflectance will be assessed by SkinSkan instrument. SkinSkan instrument is a non-invasive diagnostic tool that uses an optical fiber probe to collect the signal from skin after excitation light is delivered through the same fiber probe. The spectra acquired at post sunscreen application and baseline for each site will be used to calculate Sun Protection Factor (SPF) following published Hybrid Diffuse Reflectance Spectroscopy (HDRS) method. Four replicates of spectra will be averaged to produce mean intensity of reflectance at baseline and sunscreen covered skin. Thus, each site measurement will produce one SPF level.
Measured: Visit 1 (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start29 Dec 2021
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SunscreenStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Wrone, M.D., FAAD, Principal investigator, Validated Claim Support (VCS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565625
- Sponsor's protocol ID
- CCSSKA004479
- Other IDs
- CCSSKA004479
- Status last verified
- Oct 2023
- First submitted
- 15 Sep 2022
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
Publications
Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available.
PubMed 3377516U.S. Census Bureau. (n.d.). About race. Retrieved July 27, 2021, from https://www.census.gov/topics/population/race/about.html
U.S. Census Bureau. (n.d.). About the Hispanic population and its origin. Retrieved July 27, 2021, from https://www.census.gov/topics/population/hispanic-origin/about.html
Wan S, Anderson RR, Parrish JA. Analytical modeling for the optical properties of the skin with in vitro and in vivo applications. Photochem Photobiol. 1981 Oct;34(4):493-9. doi: 10.1111/j.1751-1097.1981.tb09391.x.
PubMed 7312955Mark Ruzon (2021). RGB2Lab (https://www.mathworks.com/matlabcentral/fileexchange/24009-rgb2lab), MATLAB Central File Exchange. Retrieved November 29, 2021.
Mosteller RD. Simplified calculation of body-surface area. N Engl J Med. 1987 Oct 22;317(17):1098. doi: 10.1056/NEJM198710223171717. No abstract available.
PubMed 3657876Murari A, Singh KN. Lund and Browder chart-modified versus original: a comparative study. Acute Crit Care. 2019 Nov;34(4):276-281. doi: 10.4266/acc.2019.00647. Epub 2019 Nov 29.
PubMed 31795625
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Clinical Study to Evaluate the Whitening Effect of Mineral Sunscreens in Multi-Cultural Skin Tones Thru Instrumentation Measurements, Imaging, and Self-Assessments
- ClinicalTrials.gov ID
- NCT05565625
- Acronym / sponsor ID
- CCSSKA004479
- Conditions
- Sunscreen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
- Study start
- 29 Dec 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 4 Oct 2022 (actual)
- 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.
The purpose of this study is to evaluate the whitening potential effect of different mineral sunscreens across multi-cultural skin tones through instrumentation, imaging, and self-assessment and also evaluate the relationship between self-perception and objective measurement of whitening.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sunscreen | Experimental | Other: Sunscreen A, Other: Sunscreen B, Other: Sunscreen C, Other: Sunscreen D, Other: Sunscreen E, Other: Sunscreen FParticipants will receive two of six sunscreens (A, B, C, D, E, and F) at Visit 1 (Day 1) to apply to whole lower legs (1 sunscreen per lower leg), between the knee and ankle. Participant will then select one of the two sunscreens randomly assigned to lower legs and apply the selected sunscreen to full face. After lower legs and facial applications are completed, a trained designee will delineate six 4 centimeters (cm)*4 cm test sites on the participants' volar forearms (3 test sites per volar forearm). The six sunscreens will be randomly assigned to the six test sites at a dose of 2.00 +- 0.05 milligrams per centimeter square (mg/cm^2) using a 1cc tuberculin syringe (without a needle) and a clean finger cot for approximately 20 to 50 seconds and applied by a trained designee. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Self-reported natural skin tone/skin color, targeting the following: skin tones "Pale/fair to light white" and "White to light beige" (n = 30 participants), skin tones "Beige to light tan/light olive" and "Medium tan/medium olive to light brown" (n = 30 participants), and Skin tones "Medium brown to dark brown" and "darkest brown to darkest black" (n = 30 participants)
- Has a history of using or is a current user of sunscreens
- Generally, in good health based on medical history reported by the participants
- Able to read, write, speak, and understand English
- Individual has signed the consent for photograph release and informed consent document (ICD) including Health Insurance Portability and Accountability Act (HIPAA) disclosure
Key exclusion criteria (13 listed)
- Has known allergies or adverse reactions to common topical skincare products or ingredients in the ISMs
- Presents with a skin condition on the face, volar forearms, or lower legs that may confound the study results (example, psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, or active skin cancer) or interfere with evaluations (example, excessive hair, tattoos, scarring, very uneven skin tone, sunburn, scratches/broken/compromised skin)
- Has shaved or used any hair removal method on lower legs or volar forearms within 24 hours of Visit 1
- Has a history of a confirmed or suspected coronavirus disease 2019 (COVID-19) infection within 30 days prior to the study visit
- Within 14 days prior to Visit 1, has been in close contact (exposure within 6 feet for a cumulative time of 15 minutes or more over a 24-hour period) with anyone who has been infected with COVID-19
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 AParticipants will topically apply Sunscreen A at Visit 1. | Other | Sunscreen |
| Sunscreen BParticipants will apply Sunscreen B at Visit 1. | Other | Sunscreen |
| Sunscreen CParticipants will apply Sunscreen C at Visit 1. | Other | Sunscreen |
| Sunscreen DParticipants will apply Sunscreen D at Visit 1. | Other | Sunscreen |
| Sunscreen EParticipants will apply Sunscreen E at Visit 1. | Other | Sunscreen |
| Sunscreen FParticipants will apply Sunscreen F at Visit 1. | Other | Sunscreen |
Primary outcome
Whitening Potential of Mineral Sunscreens Across Multi-cultural Skin Tones Through Instrumentation
Time frame: Visit 1 (Day 1)
Whitening potential of mineral sunscreens across multi-cultural skin tones through instrumentation (SkinSkan measurements) will be reported. SkinSkan is a non-invasive diagnostic tool that uses an optical fiber probe to collect the fluorescence signal from skin after excitation light is delivered through the same fiber probe.
Whitening Potential of Mineral Sunscreens Across Multi-cultural Skin Tones Through Imaging
Time frame: Visit 1 (Day 1)
Whitening potential of mineral sunscreens across multi-cultural skin tones through imaging (facial and vocal forearms) will be reported. Image analysis will be done by using the Matlab software. A small region of interest (ROI) will be defined on the gray standard, and five regions on the face (forehead, nose, chin, left cheek, and right cheek) and the test regions on the volar forearms. The average RGB (red, green, and blue) values from these ROI will be extracted from the images. The RGB values from the gray standard will be used to calculate the correction factors per image based on the gray standard's target RGB values. Matlab will be used to convert the corrected RGB values to the LAB values. Skin whitening defined as the change in L* values pre and post product application. L* value is defined as lightness in LAB color space. High L* value corresponds to whiter color while low L* value corresponds to blacker color.
Whitening Potential of Mineral Sunscreens Across Multi-cultural Skin Tones Through Self-assessment
Time frame: Visit 1 (Day 1)
Whitening potential of mineral sunscreens across multi-cultural skin tones through self-assessment will be reported via self-assessment questionnaire (Part B). This questionnaire rank whitening potential after application of the sunscreen product to the designated test areas on both inner forearms in order of least whitening (1) to most whitening (6).
Relationship Between Self-assessment and Instrumentation
Time frame: Visit 1 (Day 1)
Relationship between self-assessment and instrumentation (sunscreen product) will be reported via self-assessment questionnaire (Part A) which include the question about 'how much did you like or dislike the appearance of the sunscreen product on your skin' rated on a 5-point likert scale where 1 indicates "disliked it very much", 2 indicates "disliked it somewhat", 3 indicates "neither liked or disliked it", 4 indicates "liked it somewhat" and 5 indicates "liked it very much".
2 secondary outcomes
Rate of Usage Versus Whitening Effect from a Sunscreen
Time frame: Visit 1 (Day 1)
Skin Reflectance Before and After Sunscreen Applications as Assessed by SkinSkan Instrument
Time frame: Visit 1 (Day 1)
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 25 Oct 2023.
- Background: PubMed 3377516Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available.
- BackgroundU.S. Census Bureau. (n.d.). About race. Retrieved July 27, 2021, from https://www.census.gov/topics/population/race/about.html
- BackgroundU.S. Census Bureau. (n.d.). About the Hispanic population and its origin. Retrieved July 27, 2021, from https://www.census.gov/topics/population/hispanic-origin/about.html
- Background: PubMed 7312955Wan S, Anderson RR, Parrish JA. Analytical modeling for the optical properties of the skin with in vitro and in vivo applications. Photochem Photobiol. 1981 Oct;34(4):493-9. doi: 10.1111/j.1751-1097.1981.tb09391.x.
- BackgroundMark Ruzon (2021). RGB2Lab (https://www.mathworks.com/matlabcentral/fileexchange/24009-rgb2lab), MATLAB Central File Exchange. Retrieved November 29, 2021.
- Background: PubMed 3657876Mosteller RD. Simplified calculation of body-surface area. N Engl J Med. 1987 Oct 22;317(17):1098. doi: 10.1056/NEJM198710223171717. No abstract available.
- Background: PubMed 31795625Murari A, Singh KN. Lund and Browder chart-modified versus original: a comparative study. Acute Crit Care. 2019 Nov;34(4):276-281. doi: 10.4266/acc.2019.00647. Epub 2019 Nov 29.
- Redacted CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
Related trials for Sunscreen
Enrolling by invitationObservational study
Expert Consensus on Photoprotection Practices: A Delphi Study
Photoprotection, Sunscreen
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.
David Wrone, M.D., FAAD principal investigator
Validated Claim Support (VCS)
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 A, Sunscreen B and Sunscreen C in people with Sunscreen, run by Johnson & Johnson Consumer Inc. (J&JCI) 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 6 inclusion and 13 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 25 Oct 2023. 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?
Whitening Potential of Mineral Sunscreens Across Multi-cultural Skin Tones Through Instrumentation (time frame: Visit 1 (Day 1)). The study lists 4 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 NCT05565625, which also lists 7 linked publications.
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 25 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.