Visible Light Exposure on Healthy Back SkinBIOVI2NCT06937515
MELASYL EFFICACY UNDER PART OF VISIBLE LIGHT
An observational study of Visible Light Exposure on Healthy Back Skin, run by L'Oreal at 1 site in Romania.
Trial summary
The study intends to evaluate the efficacy of an anti-melanogenesis active in different concentrations under part of visible Light [400-450nm] exposures and under full visible light [400-700nm] exposures. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Visible Light Exposure on Healthy Back Skin
- What is being tested?
- Cosmetic topical products
- How many people
- 31 participants
- Where
- 1 siteRomania
- Study dates
- 27 Mar 2023to 1 Sep 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy male and female volunteers from 18 to 65 yo, with Fitzpatrick III and IV and an ITA° between 18° to 34° at screening.
Who may be able to join
- Healthy female or male volunteer from 18 to 65 years old
- Skin type III-IV according to the Fitzpatrick classification
- Average ITA° (Individual Typologic Angle calculated value) on the back between 18° and 34° at screening and inclusion visits with an allowed difference of ± 2° between screening and inclusion visits
- Uniform skin color over the eight 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
- 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)
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- 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 inform consent
Who cannot join
- Subject who is pregnant or lactating or who is planning to become pregnant during the study
- Subject with BMI > 30
- 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
- Dermatological disorders affecting the investigational area (presence of naevi, freckles, excess hair or uneven skin tones, vitiligo, photo-dermatological problems
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- 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 swim 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: EVALUATION OF THE EFFICACY OF AN ANTIMELANOGENESIS AGENT (MELASYL) IN DIFFERENT CONCENTRATIONS UNDER PART OF VISIBLE LIGHT [400-450NM] EXPOSURES AND UNDER FULL VISIBLE LIGHT [400-700NM] EXPOSURES
The study intends to evaluate the efficacy of an anti-melanogenesis active in different concentrations under part of visible Light [400-450nm] exposures and under full visible light [400-700nm] exposures.
It is carried out on cosmetic products for which the safety has been assured by a toxicologist, with the aim of confirming the efficacy of the products, which will be used by a large number of consumers under normal and reasonably foreseeable use conditions.
Read the detailed description
The main objective of this study is to assess the efficacy of an anti-melanogenesis active in different concentrations under [400-450nm] exposures and under [400-700nm] in healthy volunteers by skin colorimetry (Delta E).
The secondary objectives are:
- To assess the efficacy of anti-melanogenesis active in different concentrations under [400-450nm] exposures and under [400-700nm] exposures in healthy volunteers by clinical evaluation and additional colorimetry measurements (Delta L*, a*, b* and ITA°).
- To assess the local tolerance and safety of the topical formulations under [400-450nm] exposure and under [400-700nm] by recording adverse events and safety.
- Being tested
- Cosmetic topical products
- Keywords
- pigmentation, visible light, full visible light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosmetic topical productsOther
Cosmetic topical products efficacy evaluation
| Study group | Role | What they receive |
|---|---|---|
| Melasyl at 1% and 0.5% versus its vehicle under High Energy Visible light or full visible light | A total of eight (8) zones of 3x3cm will be delineated on the back, four (4) zones per hemi-back (left and right) and exposed under UVA1+physical multilayer filter cut-off wavelengths under 400nm for [400-450nm] OR exposed under full visible light for [400-700nm].
- Three (3) zones per hemi-back will be treated with topical treatments during the 7 weeks of the study: IP1: Melasyl 1% in Bright Matte (893286 03) IP2: Melasyl 0.5% in Bright Matte (893286 02) IP3: Bright Matte vehicle (893286 P)
- One (1) zone per hemi-back will not be treated (control NT) Receives: Other: Cosmetic topical products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin color measurement
Measurement of the skin color using Chromameter® (non-invasive assessment) between the exposed zone (ZE) and non-exposed zone (ZNE).
Measured: from Day 1 to Day 47.
Secondary outcomes (2)
Visual scoring of pigmentation
Visual evaluation of the pigmentation using L'Oreal pigmentation scale (0-13 points)
Measured: from Day 1 to Day 47.
Visual scoring of erythema
Visual evaluation of the erythema using L'Oreal pigmentation scale (0-13 points)
Measured: from Day 1 to Day 47.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start27 Mar 2023
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 31 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
- NCT06937515
- Sponsor's protocol ID
- ACR_BIOVI2_23-02381
- Acronym
- BIOVI2
- Status last verified
- Apr 2025
- First submitted
- 20 Apr 2025
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Piffaut V, De Dormael R, Belaidi JP, Bertrand L, Passeron T, Bernerd F, Marionnet C. Topical prevention from high energy visible light-induced pigmentation by 2-mercaptonicotinoyl glycine, but not by ascorbic acid antioxidant: 2 randomized controlled trials. Front Pharmacol. 2025 Oct 9;16:1651068. doi: 10.3389/fphar.2025.1651068. eCollection 2025.
PubMed 41142247
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE EFFICACY OF AN ANTIMELANOGENESIS AGENT (MELASYL) IN DIFFERENT CONCENTRATIONS UNDER PART OF VISIBLE LIGHT [400-450NM] EXPOSURES AND UNDER FULL VISIBLE LIGHT [400-700NM] EXPOSURES
- ClinicalTrials.gov ID
- NCT06937515
- Acronym / sponsor ID
- BIOVI2 / ACR_BIOVI2_23-02381
- Keywords
- pigmentation, visible light, full visible light
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- L'OrealIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 22 Apr 2025 (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 evaluate the efficacy of an anti-melanogenesis active in different concentrations under part of visible Light [400-450nm] exposures and under full visible light [400-700nm] exposures.
It is carried out on cosmetic products for which the safety has been assured by a toxicologist, with the aim of confirming the efficacy of the products, which will be used by a large number of consumers under normal and reasonably foreseeable use conditions.
Detailed description
The main objective of this study is to assess the efficacy of an anti-melanogenesis active in different concentrations under [400-450nm] exposures and under [400-700nm] in healthy volunteers by skin colorimetry (Delta E).
The secondary objectives are:
- To assess the efficacy of anti-melanogenesis active in different concentrations under [400-450nm] exposures and under [400-700nm] exposures in healthy volunteers by clinical evaluation and additional colorimetry measurements (Delta L*, a*, b* and ITA°).
- To assess the local tolerance and safety of the topical formulations under [400-450nm] exposure and under [400-700nm] by recording adverse events and safety.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Melasyl at 1% and 0.5% versus its vehicle under High Energy Visible light or full visible light | – | Other: Cosmetic topical productsA total of eight (8) zones of 3x3cm will be delineated on the back, four (4) zones per hemi-back (left and right) and exposed under UVA1+physical multilayer filter cut-off wavelengths under 400nm for [400-450nm] OR exposed under full visible light for [400-700nm]. - Three (3) zones per hemi-back will be treated with topical treatments during the 7 weeks of the study: IP1: Melasyl 1% in Bright Matte (893286 03) IP2: Melasyl 0.5% in Bright Matte (893286 02) IP3: Bright Matte vehicle (893286 P) - One (1) zone per hemi-back will not be treated (control NT) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy male and female volunteers from 18 to 65 yo, with Fitzpatrick III and IV and an ITA° between 18° to 34° at screening.
Key inclusion criteria (10 listed)
- Healthy female or male volunteer from 18 to 65 years old
- Skin type III-IV according to the Fitzpatrick classification
- Average ITA° (Individual Typologic Angle calculated value) on the back between 18° and 34° at screening and inclusion visits with an allowed difference of ± 2° between screening and inclusion visits
- Uniform skin color over the eight 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
Key exclusion criteria (19 listed)
- Subject who is pregnant or lactating or who is planning to become pregnant during the study
- Subject with BMI > 30
- 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
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 |
|---|---|---|
| Cosmetic topical productsCosmetic topical products efficacy evaluation | Other | Melasyl at 1% and 0.5% versus its vehicle under High Energy Visible light or full visible light |
Primary outcome
Skin color measurement
Time frame: from Day 1 to Day 47.
Measurement of the skin color using Chromameter® (non-invasive assessment) between the exposed zone (ZE) and non-exposed zone (ZNE).
2 secondary outcomes
Visual scoring of pigmentation
Time frame: from Day 1 to Day 47.
Visual scoring of erythema
Time frame: from Day 1 to Day 47.
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 22 Apr 2025.
- Derived from this study: PubMed 41142247Piffaut V, De Dormael R, Belaidi JP, Bertrand L, Passeron T, Bernerd F, Marionnet C. Topical prevention from high energy visible light-induced pigmentation by 2-mercaptonicotinoyl glycine, but not by ascorbic acid antioxidant: 2 randomized controlled trials. Front Pharmacol. 2025 Oct 9;16:1651068. doi: 10.3389/fphar.2025.1651068. eCollection 2025.
- 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 Romania.
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 10 inclusion and 19 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 22 Apr 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 Romania. 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 (time frame: from Day 1 to Day 47.). 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 NCT06937515, which also lists 1 linked publication.
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 22 Apr 2025.