Visible Light Exposure on Healthy Back SkinVLADNCT07462845
Agents Effect Under Visible Light on Caucasian, Asian and Darker Skin Types
An observational study of Visible Light Exposure on Healthy Back Skin, run by L'Oreal at 1 site in France.
Trial summary
The study intends to get knowledge on pigmentation induced by visible light on Asian/Chinese skin type and darker skin type, and to evaluate and to compare with a non-treated control zone and between them, the efficacy of photoprotective effect of different products after visible light exposure, between [400-700nm]… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Visible Light Exposure on Healthy Back Skin
- Type of treatment
- Injection or infusion
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 5 Sep 2022to 15 Dec 2022
- Phase
- Observational
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy male and female volunteers from 18 to 50 yo, with Fitzpatrick III to VI and an ITA° between -30° to +36° at screening.
Who may be able to join
- To be enrolled in this study, all subjects must satisfy all the following criteria at study entry:
- Healthy female or male volunteer from 18 to 50 years old
- Caucasian Skin type III-IV according to the Fitzpatrick classification OR Asian Skin type III-IV (chinese population) according to the Fitzpatrick classification OR Darker Skin type VI according to the Fitzpatrick classification
- Average ITA° (Individual Typologic Angle calculated value) on the back between 24° and 36° at screening and inclusion visits with an allowed difference of ± 2° between screening and inclusion visits, for Caucasian volunteers OR Average ITA° (Individual Typologic Angle calculated value) on the back between 24° and 36° at screening and inclusion visits with an allowed difference of ± 2° between screening and inclusion visits, for Asian volunteers OR Average ITA° (Individual Typologic Angle calculated value) on the back less than -30° at screening and inclusion visits with an allowed difference of ± 2° between screening and inclusion visits, for Darker skin volunteers
- Uniform skin color over the four zones (difference in ITA° between each zone should not be more than 4°)
- Absence of freckles, naevi, hypo or hyper pigmented regions, hairs and marks of bronzing on the investigational area on the back
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- Female subject of childbearing potential, who is not sexually active, or using an effective contraceptive method* for at least one month before the beginning of the study, and throughout the study or menopausal female (with absence of menstruations for less than one year) or post-menopausal female (with absence of menstruations for more than one year)
- Effective contraceptive methods: sexually active female of childbearing potential should either be surgically sterile (oophorectomy, hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intravaginal device, intrauterine device (IUD), condom with spermicide
- Female of childbearing potential or menopausal female (with absence of menstruations for less than one year) willing to undergo urine pregnancy test
- Subject willing and able to fulfil the study requirements and schedule
- Subject informed about the study objectives and procedures, and able to understand them
- Subject who has given written informed consent
Who cannot join
- If any following non-inclusion criterion applies, the subject must not be included in the study:
- Subject who is pregnant or lactating or who is planning to become pregnant during the study
- Subject with BMI > 30 except if, according to the investigator's judgement, the subject is able to follow the study procedure without compromising his/her health
- Having planned UV exposure of the investigational area (sunlight or sunbeds) throughout the study
- Having used sunbeds or had excessive sun exposure of the investigational area within the 3 months before inclusion
- Having sunburn (erythema) on the back
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- Dermatological disorders affecting the investigational area (presence of naevi, freckles, excess hair or uneven skin tones, vitiligo, photo-dermatological problems)
- History of skin cancer
- History of abnormal response to sun
- Presence of recent suntan (according to Investigator opinion) or photo-test marks
- History of allergy, hypersensitivity, or any serious reaction to any cosmetic product
- Any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator
- Having used within the month before inclusion any systemic medication for more than 5 consecutive days (e.g. steroidal and non-steroidal anti-inflammatory drugs, corticoids, insulin, antihistamines, antihypertensive, antibiotics such as quinolone, tetracycline, thiazides, fluoroquinolones)
- Having used within the month before inclusion any medication known to cause abnormal responses to UV exposure (e.g. vitamin A derivative, psoralen, aminolevulinic acid derivatives, etc.), or having planned to use these medications during the study
- Having used within the 3 months before inclusion any depigmenting / whitening or pro-pigmenting topical treatments, or any systemic treatment that would interfere with the study assessments (anti-inflammatory drugs, corticoids, retinoids, hydroquinone, etc.) or having planned to use these treatments during the study
- Having used, within the past 6 months, any physical treatment including laser or phototherapy (PUVA, IPL, PDT…) on the investigational area, or having planned to use these treatments during the study
- Having planned to perform intensive sport (> 5 hours per week) or to swim or to practice hammam/sauna during the study
- Subject who declares to be deprived of freedom by administrative or legal decision
- Subject who cannot be contacted by telephone in case of emergency
- Subject having participated within the 30 days before inclusion or currently participating in another clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Protective Effect of Different Agents on Visible Light Induced Pigmentation Compared With an Untreated Control Zone, on Caucasian, Asian and Darker Skin Types
The study intends to get knowledge on pigmentation induced by visible light on Asian/Chinese skin type and darker skin type, and to evaluate and to compare with a non-treated control zone and between them, the efficacy of photoprotective effect of different products after visible light exposure, between [400-700nm], on these skin types compared to Caucasian for whom the investigators already got knowledge.
Read the detailed description
The main objective of this study is:
- To assess the ability of protective agents to prevent the pigmentation under visible light exposures (VL) in healthy volunteers with different skin type (caucasian, asian and darker skin) by skin colorimetry (Delta E) and clinical evaluation.
The secondary objectives are:
- To assess the local tolerance and safety of the products under VL exposure by recording adverse events and safety
- To assess the safety of the different Investigational Products.
- Keywords
- pigmentation, visible light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Caucasian | 22 volunteers Caucasian skin with a skin phototype III or IV | |
| Asian | 22 volunteers Asian skin with a skin phototype III-IV | |
| Darker skin | 22 volunteers darker skin with a skin phototype VI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin color measurement with ITA° angle
The device Chromameter® (non-invasive assessment) will be used to measure the skin color, between the exposed zone (ZE) and non-exposed zone (ZNE), through the ITA° angle calculation, using formula [Arc Tangent ((L* - 50) / b*)] 180 / p.
The L* defines the perceptual lightness from black at 0 to white at 100. The b* represents the blue-yellow opponents, with negative numbers toward blue and positive toward yellow.
Measured: From enrollment at Day 1 to the end of study at Day 12
Skin pigmentation contrast
The device Chromameter® (non-invasive assessment) will be used to measure the skin contrast, between the exposed zone (ZE) and non-exposed zone (ZNE), through the Delta E calculation, using formula √ (ΔL*2+Δa*2+Δb*2)).
The L* defines the perceptual lightness from black at 0 to white at 100. The a* axis is relative to the green-red opponent colors, with negative values toward green and positive values toward red.
The b* represents the blue-yellow opponents, with negative numbers toward blue and positive toward yellow.
Measured: From enrollment at Day 1 to the end of study at Day 12
Secondary outcomes (2)
Visual scoring of pigmentation
A trained investigator will visually score the skin pigmentation, using L'Oreal pigmentation scale :
0 Absence
- Barely visible
- Very pale brown -
- Very pale brown
- Very pale brown +
- Pale brown -
- Pale brown
- Pale brown +
- Brown -
- Brown
- Brown +
- Pronounced brown -
- Pronounced brown
- Pronounced brown +
Measured: From enrollment at Day 1 to the end of study at Day 12
Visual scoring of erythema
A trained investigator will visually score the skin erythema, using L'Oreal erythema scale :
0 Absence
- Barely visible
- Very pale pink -
- Very pale pink
- Very pale pink +
- Pale pink -
- Pale pink
- Pale pink +
- Pink -
- Pink
- Pink +
- Pronounced pink -
- Pronounced pink
- Pronounced pink +
Measured: From enrollment at Day 1 to the end of study at Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start5 Sep 2022
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visible Light Exposure on Healthy Back SkinStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- L'Oreal
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462845
- Sponsor's protocol ID
- ACR_VLAD_22-08057
- Acronym
- VLAD
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2026
- Last updated
- 10 Mar 2026
- 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 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Protective Effect of Different Agents on Visible Light Induced Pigmentation Compared With an Untreated Control Zone, on Caucasian, Asian and Darker Skin Types
- ClinicalTrials.gov ID
- NCT07462845
- Acronym / sponsor ID
- VLAD / ACR_VLAD_22-08057
- Keywords
- pigmentation, visible light
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- L'OrealIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 10 Mar 2026 (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 study intends to get knowledge on pigmentation induced by visible light on Asian/Chinese skin type and darker skin type, and to evaluate and to compare with a non-treated control zone and between them, the efficacy of photoprotective effect of different products after visible light exposure, between [400-700nm], on these skin types compared to Caucasian for whom the investigators already got knowledge.
Detailed description
The main objective of this study is:
- To assess the ability of protective agents to prevent the pigmentation under visible light exposures (VL) in healthy volunteers with different skin type (caucasian, asian and darker skin) by skin colorimetry (Delta E) and clinical evaluation.
The secondary objectives are:
- To assess the local tolerance and safety of the products under VL exposure by recording adverse events and safety
- To assess the safety of the different Investigational Products.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Caucasian | – | –22 volunteers Caucasian skin with a skin phototype III or IV |
| Asian | – | –22 volunteers Asian skin with a skin phototype III-IV |
| Darker skin | – | –22 volunteers darker skin with a skin phototype VI |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy male and female volunteers from 18 to 50 yo, with Fitzpatrick III to VI and an ITA° between -30° to +36° at screening.
Key inclusion criteria (12 listed)
- To be enrolled in this study, all subjects must satisfy all the following criteria at study entry:
- Effective contraceptive methods: sexually active female of childbearing potential should either be surgically sterile (oophorectomy, hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intravaginal device, intrauterine device (IUD), condom with spermicide
Key exclusion criteria (20 listed)
- If any following non-inclusion criterion applies, the subject must not be included in 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.
Primary outcome
Skin color measurement with ITA° angle
Time frame: From enrollment at Day 1 to the end of study at Day 12
The device Chromameter® (non-invasive assessment) will be used to measure the skin color, between the exposed zone (ZE) and non-exposed zone (ZNE), through the ITA° angle calculation, using formula [Arc Tangent ((L* - 50) / b*)] 180 / p. The L* defines the perceptual lightness from black at 0 to white at 100. The b* represents the blue-yellow opponents, with negative numbers toward blue and positive toward yellow.
Skin pigmentation contrast
Time frame: From enrollment at Day 1 to the end of study at Day 12
The device Chromameter® (non-invasive assessment) will be used to measure the skin contrast, between the exposed zone (ZE) and non-exposed zone (ZNE), through the Delta E calculation, using formula √ (ΔL*2+Δa*2+Δb*2)). The L* defines the perceptual lightness from black at 0 to white at 100. The a* axis is relative to the green-red opponent colors, with negative values toward green and positive values toward red. The b* represents the blue-yellow opponents, with negative numbers toward blue and positive toward yellow.
2 secondary outcomes
Visual scoring of pigmentation
Time frame: From enrollment at Day 1 to the end of study at Day 12
Visual scoring of erythema
Time frame: From enrollment at Day 1 to the end of study at Day 12
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 10 Mar 2026.
- Individual participant dataSharing planned: No
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?
An observational study of Visible Light Exposure on Healthy Back Skin, run by L'Oreal at 1 site in France.
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 12 inclusion and 20 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 10 Mar 2026. 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 France. 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?
Skin color measurement with ITA° angle (time frame: From enrollment at Day 1 to the end of study at Day 12). 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?
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 10 Mar 2026.