SunscreenNCT06734299
A Study to Evaluate Usage of Mineral Sunscreens With Differentiated Whitening Attributes 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 the study is to evaluate the whitening potential of different mineral and chemical sunscreens across multi-cultural skin tones through instrumentation, imaging, and self-assessment. It also aimed to evaluate the relationship between self-perception and objective measurements 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
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2024to 14 Feb 2025
- 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 = 15 participants), skin tones "Beige to light tan/light olive" and "Medium tan/medium olive to light brown" (N = 15 participants), skin tones "Medium brown to dark brown and "Darkest brown to darkest black" (N = 15 participants)
- Has a history of using or is a current user of sunscreens
- Is willing to have height and body weight measured and recorded
- Generally in good health based on medical history reported by the participants
- Is able to read, write, speak, and understand English or Spanish
- Has signed the ICD including Health Insurance Portability and Accountability Act (HIPAA) disclosure and Photograph Release
- 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 IPs
- Presents with a skin condition and/or pre-existing or dormant dermatologic disease on the face, volar forearms, or lower legs that may confound the study results (e.g., psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, or active skin cancer, rosacea, moderate to severe acne, acne conglobate, nodules, and/or cysts on the face) or interfere with evaluations (e.g., excessive hair, tattoos, scarring, nevi, very uneven skin tone, sunburn, scratches/broken/compromised skin)
- Has had any facial treatments including facials, facial peels, photo facials, laser treatments, dermabrasion, botulinum toxin (Botox), injectable filler treatments, intense pulsed light (IPL), acid treatments, tightening treatments, facial plastic surgery, or any other treatment administered by a physician or skin care professional designed to improve the appearance or firmness of facial skin withing 30 days prior to Visit 1
- Has shaved or used any hair removal method on lower legs or volar forearms within 24 hours of Visit 1
- Has a history of skin cancer within the past 5 years
- Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication
Show all 14Show fewer
- Is taking a medication that would mask an Adverse Event (AE) or confuse the study results
- Has a history of immunosuppression/immune deficiency disorders (including HIV infection, AIDS, multiple sclerosis, Crohn's disease, rheumatoid arthritis), organ transplant (heart, kidney, etc.), and/or undergoing radiation or chemotherapy as determined by study documentation
- Has a disease such as asthma, epilepsy, hypertension, hyperthyroidism, or hypothyroidism that is not controlled by diet or medication. Individuals having multiple health conditions may be excluded from participation even if the conditions are controlled by diet, medication, etc.
- Is self-reported to be breast feeding, 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, confuse the study results, or interfere significantly with the individual's participation in the study
- Has started any long-term medication within the last 2 months
- Is simultaneously participating in any other clinical study or has participated in any product-use study within 30 days prior to Visit 1
- Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor
Trial locations and contacts
1 site in 1 country.
United States1 site
SGS North America Inc. - Union Research Center
Union, New Jersey, 07083
About this study
Official title: A Single-Center, Randomized, Clinical Study to Evaluate Usage of Facial Mineral Sunscreens With Differentiated Whitening Attributes in Multi-Cultural Skin Tones Through Instrumentation Measurements, Imaging, and Self-Assessments
The purpose of the study is to evaluate the whitening potential of different mineral and chemical sunscreens across multi-cultural skin tones through instrumentation, imaging, and self-assessment. It also aimed to evaluate the relationship between self-perception and objective measurements of whitening.
- Conditions
- Sunscreen
- Being tested
- Sunscreen A, Sunscreen B, Sunscreen C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunscreen AOther
Sunscreen A will be applied to both lower legs (between the knee and ankle) and then her full face to the randomly assigned participants at Visit1, Visit 2, and Visit 3.
Sunscreen BOther
Sunscreen B will be applied to both lower legs (between the knee and ankle) and then her full face to the randomly assigned participants at Visit1, Visit 2, and Visit 3.
Sunscreen COther
Sunscreen C will be applied to both lower legs (between the knee and ankle) and then her full face to the randomly assigned participants at Visit1, Visit 2, and Visit 3.
| Study group | Role | What they receive |
|---|---|---|
| Sunscreen A | Experimental | At each visit, each enrolled subject will be randomly assigned 1 of the 3 Sunscreens to apply to both lower legs (between the knee and ankle) and then her full face. The subject will cleanse her hands with soap and water between the lower legs and face Sunscreen applications.
After lower legs and facial Sunscreen applications are completed, a trained designee will delineate six 4 cm x 4 cm test sites on the subject's volar forearms (3 test sites per volar forearm). Then a trained designee will apply the assigned Sunscreen to the designated test sites in a consistent manner at a randomly assigned dose density of 0.25, 0.50, 0.75, 1.00, 1.50, and 2.00 mg/cm2 (± 10%) per the randomization schedule using a 1cc tuberculin syringe (without a needle) or pipette and a clean finger cot for approximately 20 to 50 seconds. Receives: Other: Sunscreen A |
| Sunscreen B | Experimental | At each visit, each enrolled subject will be randomly assigned 1 of the 3 Sunscreens to apply to both lower legs (between the knee and ankle) and then her full face. The subject will cleanse her hands with soap and water between the lower legs and face Sunscreen applications.
After lower legs and facial Sunscreen applications are completed, a trained designee will delineate six 4 cm x 4 cm test sites on the subject's volar forearms (3 test sites per volar forearm). Then a trained designee will apply the assigned Sunscreen to the designated test sites in a consistent manner at a randomly assigned dose density of 0.25, 0.50, 0.75, 1.00, 1.50, and 2.00 mg/cm2 (± 10%) per the randomization schedule using a 1cc tuberculin syringe (without a needle) or pipette and a clean finger cot for approximately 20 to 50 seconds. Receives: Other: Sunscreen B |
| Sunscreen C | Experimental | At each visit, each enrolled subject will be randomly assigned 1 of the 3 Sunscreens to apply to both lower legs (between the knee and ankle) and then her full face. The subject will cleanse her hands with soap and water between the lower legs and face Sunscreen applications.
After lower legs and facial Sunscreen applications are completed, a trained designee will delineate six 4 cm x 4 cm test sites on the subject's volar forearms (3 test sites per volar forearm). Then a trained designee will apply the assigned Sunscreen to the designated test sites in a consistent manner at a randomly assigned dose density of 0.25, 0.50, 0.75, 1.00, 1.50, and 2.00 mg/cm2 (± 10%) per the randomization schedule using a 1cc tuberculin syringe (without a needle) or pipette and a clean finger cot for approximately 20 to 50 seconds. Receives: Other: Sunscreen C |
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 (Chroma Meter and Polychromatic Hybrid Diffuse Reflectance Spectroscopy measurements) will be reported.
Measured: Visit 1 (Day 1), Visit 2 (Day 7) and Visit 3 (Day 14)
Whitening Potential of Mineral Sunscreens Across Multi-cultural Skin Tones Through Imaging
Whitening potential of mineral sunscreens across multi-cultural skin tones through imaging (Full-Face Imaging via VISIA-CR and Volar Forearms Imaging via Digital Camera) will be reported.
Measured: Visit 1 (Day1), Visit 2 (Day 7) and Visit 3 (Day 14)
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.
Measured: Visit 1 (Day1), Visit 2 (Day 7) and Visit 3 (Day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start6 Dec 2024
- Primary completion14 Feb 2025
- Study completion14 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734299
- Sponsor's protocol ID
- CS2024SK100197
- Status last verified
- Nov 2024
- First submitted
- 12 Dec 2024
- Last updated
- 28 Feb 2025
- 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 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Clinical Study to Evaluate Usage of Facial Mineral Sunscreens With Differentiated Whitening Attributes in Multi-Cultural Skin Tones Through Instrumentation Measurements, Imaging, and Self-Assessments
- ClinicalTrials.gov ID
- NCT06734299
- Acronym / sponsor ID
- CS2024SK100197
- Conditions
- Sunscreen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 14 Feb 2025 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 16 Dec 2024 (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 the study is to evaluate the whitening potential of different mineral and chemical sunscreens across multi-cultural skin tones through instrumentation, imaging, and self-assessment. It also aimed to evaluate the relationship between self-perception and objective measurements of whitening.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sunscreen A | Experimental | Other: Sunscreen AAt each visit, each enrolled subject will be randomly assigned 1 of the 3 Sunscreens to apply to both lower legs (between the knee and ankle) and then her full face. The subject will cleanse her hands with soap and water between the lower legs and face Sunscreen applications. After lower legs and facial Sunscreen applications are completed, a trained designee will delineate six 4 cm x 4 cm test sites on the subject's volar forearms (3 test sites per volar forearm). Then a trained designee will apply the assigned Sunscreen to the designated test sites in a consistent manner at a randomly assigned dose density of 0.25, 0.50, 0.75, 1.00, 1.50, and 2.00 mg/cm2 (± 10%) per the randomization schedule using a 1cc tuberculin syringe (without a needle) or pipette and a clean finger cot for approximately 20 to 50 seconds. |
| Sunscreen B | Experimental | Other: Sunscreen BAt each visit, each enrolled subject will be randomly assigned 1 of the 3 Sunscreens to apply to both lower legs (between the knee and ankle) and then her full face. The subject will cleanse her hands with soap and water between the lower legs and face Sunscreen applications. After lower legs and facial Sunscreen applications are completed, a trained designee will delineate six 4 cm x 4 cm test sites on the subject's volar forearms (3 test sites per volar forearm). Then a trained designee will apply the assigned Sunscreen to the designated test sites in a consistent manner at a randomly assigned dose density of 0.25, 0.50, 0.75, 1.00, 1.50, and 2.00 mg/cm2 (± 10%) per the randomization schedule using a 1cc tuberculin syringe (without a needle) or pipette and a clean finger cot for approximately 20 to 50 seconds. |
| Sunscreen C | Experimental | Other: Sunscreen CAt each visit, each enrolled subject will be randomly assigned 1 of the 3 Sunscreens to apply to both lower legs (between the knee and ankle) and then her full face. The subject will cleanse her hands with soap and water between the lower legs and face Sunscreen applications. After lower legs and facial Sunscreen applications are completed, a trained designee will delineate six 4 cm x 4 cm test sites on the subject's volar forearms (3 test sites per volar forearm). Then a trained designee will apply the assigned Sunscreen to the designated test sites in a consistent manner at a randomly assigned dose density of 0.25, 0.50, 0.75, 1.00, 1.50, and 2.00 mg/cm2 (± 10%) per the randomization schedule using a 1cc tuberculin syringe (without a needle) or pipette and a clean finger cot for approximately 20 to 50 seconds. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Self-reported natural skin tone/skin color targeting the following: skin tones "Pale/fair to light white" and "White to light beige" (N = 15 participants), skin tones "Beige to light tan/light olive" and "Medium tan/medium olive to light brown" (N = 15 participants), skin tones "Medium brown to dark brown and "Darkest brown to darkest black" (N = 15 participants)
- Has a history of using or is a current user of sunscreens
- Is willing to have height and body weight measured and recorded
- Generally in good health based on medical history reported by the participants
- Is able to read, write, speak, and understand English or Spanish
Key exclusion criteria (14 listed)
- Has known allergies or adverse reactions to common topical skincare products or ingredients in the IPs
- Presents with a skin condition and/or pre-existing or dormant dermatologic disease on the face, volar forearms, or lower legs that may confound the study results (e.g., psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, or active skin cancer, rosacea, moderate to severe acne, acne conglobate, nodules, and/or cysts on the face) or interfere with evaluations (e.g., excessive hair, tattoos, scarring, nevi, very uneven skin tone, sunburn, scratches/broken/compromised skin)
- Has had any facial treatments including facials, facial peels, photo facials, laser treatments, dermabrasion, botulinum toxin (Botox), injectable filler treatments, intense pulsed light (IPL), acid treatments, tightening treatments, facial plastic surgery, or any other treatment administered by a physician or skin care professional designed to improve the appearance or firmness of facial skin withing 30 days prior to Visit 1
- Has shaved or used any hair removal method on lower legs or volar forearms within 24 hours of Visit 1
- Has a history of skin cancer within the past 5 years
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 ASunscreen A will be applied to both lower legs (between the knee and ankle) and then her full face to the randomly assigned participants at Visit1, Visit 2, and Visit 3. | Other | Sunscreen A |
| Sunscreen BSunscreen B will be applied to both lower legs (between the knee and ankle) and then her full face to the randomly assigned participants at Visit1, Visit 2, and Visit 3. | Other | Sunscreen B |
| Sunscreen CSunscreen C will be applied to both lower legs (between the knee and ankle) and then her full face to the randomly assigned participants at Visit1, Visit 2, and Visit 3. | Other | Sunscreen C |
Primary outcome
Whitening Potential of Mineral Sunscreens Across Multi-cultural Skin Tones Through Instrumentation
Time frame: Visit 1 (Day 1), Visit 2 (Day 7) and Visit 3 (Day 14)
Whitening potential of mineral sunscreens across multi-cultural skin tones through instrumentation (Chroma Meter and Polychromatic Hybrid Diffuse Reflectance Spectroscopy measurements) will be reported.
Whitening Potential of Mineral Sunscreens Across Multi-cultural Skin Tones Through Imaging
Time frame: Visit 1 (Day1), Visit 2 (Day 7) and Visit 3 (Day 14)
Whitening potential of mineral sunscreens across multi-cultural skin tones through imaging (Full-Face Imaging via VISIA-CR and Volar Forearms Imaging via Digital Camera) will be reported.
Whitening Potential of Mineral Sunscreens Across Multi-cultural Skin Tones Through Self-assessment
Time frame: Visit 1 (Day1), Visit 2 (Day 7) and Visit 3 (Day 14)
Whitening potential of mineral sunscreens across multi-cultural skin tones through self-assessment will be reported via self-assessment questionnaire.
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 28 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Sunscreen
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.
The record lists no contact. Use the official record to reach the sponsor.
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 7 inclusion and 14 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 28 Feb 2025. 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), Visit 2 (Day 7) and Visit 3 (Day 14)). The study lists 3 primary outcomes in all. 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 28 Feb 2025.