Skin PigmentationNCT06654102
A Study to Evaluate the Cutaneous Effects of Deep Ultraviolet A +/- High-Energy Visible Blue Light Exposure
A study testing Deep UVA Irradiation and Deep UVA+HEV Blue Light Irradiation in people with Skin Pigmentation and Photobiology, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.
Trial summary
The objective of this study is to assess the level of pigmentation following an acute exposure of skin to light regimens representative of portions of the natural sunlight spectrum and that contain Deep UVA wavelengths with or without HEV Blue Light, as compared to non-irradiated control skin. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Pigmentation, Photobiology
- What is being tested?
- Deep UVA Irradiation and Deep UVA+HEV Blue Light Irradiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2024to 26 Nov 2024
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Uniform skin color over the whole test area (the lower back) with minimal variation between test sites.
- At least 3 subjects per skin type, as defined by self-reported reaction to sun exposure and Chromameter measurements.
- Generally in good health.
- Able to read, write, speak, and understand English.
- Intends to complete the study and is willing and able to follow the subject responsibilities.
Who cannot join
- In another study without approval by the study site.
- Has known allergies or negative reactions to common topical skincare products or UV light.
- Has a history of abnormal responses to sunlight or UV radiation.
- Has used a tanning bed/lamp, has had extended sun exposure of the test area, or has participated in a UV exposure study within the past 4 weeks.
- Has a current illness/condition/situation, a medical history of a disease/condition, or a skin condition (e.g., psoriasis, rashes, eczema, seborrheic, severe excoriations, etc.) that could confuse the study results, interfere with participation, or increase health risk to the subject, as determined by the study investigator.
- Has shaved/waxed the test area within 2 weeks before Visit 1.
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- Has used any products in the test area within 24 hours before Visit 1.
- Has sunburn, suntan, scars, tattoos, active dermal lesions, nevi, or other conditions in the test area that could confuse the study results or increase health risk to the subject, as determined by the study investigator.
- Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication.
- Is immunosuppressed (such as HIV-positive, transplant patients, undergoing chemotherapy or radiotherapy, etc.).
- Has been using a product or medication that the study investigator determines will increase health risk to the subject or confuse the study results
- Has a personal or family history of skin cancer.
- Skeletal protrusions and/or extreme areas of curvature in the test area.
- Is pregnant, nursing, or planning to become pregnant.
- 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 Union Research Center, a Division of SGS North America, Inc.
Union City, New Jersey, 07083
About this study
Official title: A Controlled, Single Center Study to Evaluate the Cutaneous Effects of Deep Ultraviolet A (UVA) +/- High-Energy Visible (HEV) Blue Light Exposure
The objective of this study is to assess the level of pigmentation following an acute exposure of skin to light regimens representative of portions of the natural sunlight spectrum and that contain Deep UVA wavelengths with or without HEV Blue Light, as compared to non-irradiated control skin.
- Conditions
- Skin Pigmentation, Photobiology
- Being tested
- Deep UVA Irradiation, Deep UVA+HEV Blue Light Irradiation
- Keywords
- Skin Pigmentation, Photobiology
- Medical subject headings
- Pigmentation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep UVA IrradiationOther
A timed series of 6 UV doses will be administered to subsites 2 to 7 within Test Site 1 and 2 using an accurately calibrated solar simulator by varying the irradiation intensity for each subsite and keeping the duration of irradiation constant for all subsites. The duration of irradiation for each test site will be 30 minutes.
Deep UVA+HEV Blue Light IrradiationOther
A timed series of 6 UV doses will be administered to subsites 2 to 7 within Test Site 3 and 4 using an accurately calibrated solar simulator by varying the irradiation intensity for each subsite and keeping the duration of irradiation constant for all subsites. The duration of irradiation for each test site will be 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Regimen 1: Deep UVA | Experimental | Deep UVA, 380-400nm, will be used for subsites 2 to 7 of Test Sites 1 and 2. Receives: Other: Deep UVA Irradiation |
| Regimen 2: Deep UVA + HEV Blue Light | Experimental | Deep UVA + HEV Blue Light, 380-420 nm, will be used for subsites 2 to 7 of Test Sites 3 and 4 Receives: Other: Deep UVA+HEV Blue Light Irradiation |
| Non-irradiated control | No intervention | Subsite 1 in each test site (Test Sites 1-4) will be a non-irradiated control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pigmentation level as determined by clinical evaluation
The subsites of each test site will be graded for immediate or persistent pigmentation darkening (IPD/PPD) by a trained evaluator using a 0-2 grading scale, where 0 = no pigmentation darkening and 2 = moderate to intense pigmentation darkening.The mean values will be compared between each irradiated subsite and the non-irradiated subsite within the same test site and between each subsite in Regimen 1 compared to its corresponding subsite in Regimen 2.
Measured: 15 mins and 18-22 hours Post-Irradiation
Secondary outcomes (2)
Pigmentation response as quantified by imaging
Images of each test site will be analyzed to quantify the level of pigmentation using L* and b* color space values, where an increase in pigmentation corresponds to a decrease in L* values and a potential decrease in b* values or increase in a* values. Change from baseline will be calculated. The mean values will be compared between each irradiated subsite and the non-irradiated subsite within the same test site and between each subsite in Regimen 1 compared to its corresponding subsite in Regimen 2.
Measured: Baseline, 15 mins and 18-22 hours Post-Irradiation
Pigmentation response as quantified by Chromameter
A Chromameter will be used to quantify the level of pigmentation of subsites 1 and 7 using L* and b* color space values, where an increase in pigmentation corresponds to a decrease in L* values and a potential decrease in b* values or increase in a* values. Change from baseline will be calculated. The mean values will be compared between each irradiated subsite and the non-irradiated subsite within the same test site and between each subsite in Regimen 1 compared to its corresponding subsite in Regimen 2.
Measured: Baseline, 15 mins and 18-22 hours Post-Irradiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start23 Oct 2024
- Primary completion26 Nov 2024
- Study completion26 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin PigmentationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 4 test sites will be defined on the subjects' backs. Each test site will contain 7 subsites
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT06654102
- Sponsor's protocol ID
- CS2024SK100175
- Status last verified
- Dec 2024
- First submitted
- 21 Oct 2024
- Last updated
- 11 Dec 2024
- 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 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled, Single Center Study to Evaluate the Cutaneous Effects of Deep Ultraviolet A (UVA) +/- High-Energy Visible (HEV) Blue Light Exposure
- ClinicalTrials.gov ID
- NCT06654102
- Acronym / sponsor ID
- CS2024SK100175
- Conditions
- Skin Pigmentation, Photobiology
- Keywords
- Skin Pigmentation, Photobiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 26 Nov 2024 (actual)
- Study completion
- 26 Nov 2024 (actual)
- First posted
- 23 Oct 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 objective of this study is to assess the level of pigmentation following an acute exposure of skin to light regimens representative of portions of the natural sunlight spectrum and that contain Deep UVA wavelengths with or without HEV Blue Light, as compared to non-irradiated control skin.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 4 test sites will be defined on the subjects' backs. Each test site will contain 7 subsites
| Arm | Type | Receives |
|---|---|---|
| Regimen 1: Deep UVA | Experimental | Other: Deep UVA IrradiationDeep UVA, 380-400nm, will be used for subsites 2 to 7 of Test Sites 1 and 2. |
| Regimen 2: Deep UVA + HEV Blue Light | Experimental | Other: Deep UVA+HEV Blue Light IrradiationDeep UVA + HEV Blue Light, 380-420 nm, will be used for subsites 2 to 7 of Test Sites 3 and 4 |
| Non-irradiated control | No intervention | –Subsite 1 in each test site (Test Sites 1-4) will be a non-irradiated control |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Uniform skin color over the whole test area (the lower back) with minimal variation between test sites.
- At least 3 subjects per skin type, as defined by self-reported reaction to sun exposure and Chromameter measurements.
- Generally in good health.
- Able to read, write, speak, and understand English.
- Intends to complete the study and is willing and able to follow the subject responsibilities.
Key exclusion criteria (15 listed)
- In another study without approval by the study site.
- Has known allergies or negative reactions to common topical skincare products or UV light.
- Has a history of abnormal responses to sunlight or UV radiation.
- Has used a tanning bed/lamp, has had extended sun exposure of the test area, or has participated in a UV exposure study within the past 4 weeks.
- Has a current illness/condition/situation, a medical history of a disease/condition, or a skin condition (e.g., psoriasis, rashes, eczema, seborrheic, severe excoriations, etc.) that could confuse the study results, interfere with participation, or increase health risk to the subject, as determined by the study investigator.
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 |
|---|---|---|
| Deep UVA IrradiationA timed series of 6 UV doses will be administered to subsites 2 to 7 within Test Site 1 and 2 using an accurately calibrated solar simulator by varying the irradiation intensity for each subsite and keeping the duration of irradiation constant for all subsites. The duration of irradiation for each test site will be 30 minutes. | Other | Regimen 1: Deep UVA |
| Deep UVA+HEV Blue Light IrradiationA timed series of 6 UV doses will be administered to subsites 2 to 7 within Test Site 3 and 4 using an accurately calibrated solar simulator by varying the irradiation intensity for each subsite and keeping the duration of irradiation constant for all subsites. The duration of irradiation for each test site will be 30 minutes. | Other | Regimen 2: Deep UVA + HEV Blue Light |
Primary outcome
Pigmentation level as determined by clinical evaluation
Time frame: 15 mins and 18-22 hours Post-Irradiation
The subsites of each test site will be graded for immediate or persistent pigmentation darkening (IPD/PPD) by a trained evaluator using a 0-2 grading scale, where 0 = no pigmentation darkening and 2 = moderate to intense pigmentation darkening.The mean values will be compared between each irradiated subsite and the non-irradiated subsite within the same test site and between each subsite in Regimen 1 compared to its corresponding subsite in Regimen 2.
2 secondary outcomes
Pigmentation response as quantified by imaging
Time frame: Baseline, 15 mins and 18-22 hours Post-Irradiation
Pigmentation response as quantified by Chromameter
Time frame: Baseline, 15 mins and 18-22 hours Post-Irradiation
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 11 Dec 2024.
- Individual participant dataSharing planned: No
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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.
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 Deep UVA Irradiation and Deep UVA+HEV Blue Light Irradiation in people with Skin Pigmentation and Photobiology, 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 5 inclusion and 15 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 Dec 2024. 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?
Pigmentation level as determined by clinical evaluation (time frame: 15 mins and 18-22 hours Post-Irradiation). 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 11 Dec 2024.