Visible Light Exposures on Healthy Back SkinNCT06796140
Photoprotection Efficacy of a Sunscreen Under Visible Light Exposure by Using Two Different Simulators
An observational study of Visible Light Exposures on Healthy Back Skin, run by Cosmetique Active International at 1 site in Romania.
Trial summary
To assess the ability of a protected agent to prevent the pigmentation under visible light exposures (VL) using two different simulators in healthy volunteers 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 Exposures on Healthy Back Skin
- What is being tested?
- Visible Light Exposure - Treated zone - Left hemi-back, Visible Light Exposure - Treated zone - Right hemi-back and Visible Light Exposure - Untreated zone - Left hemi-back
- How many people
- 15 participants
- Where
- 1 siteRomania
- Study dates
- 8 Mar 2021to 9 Apr 2021
- 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 years old with phototype III to IV according to the Fitzpatrick scale and with an ITA° between 18° to 32° at Screening
Who may be able to join
- Healthy female or male volunteer from 18 to 50 years old
- Skin type III-IV according to the Fitzpatrick classification
- Average ITA° (Individual Typologic Angle calculated value) on the back between 18° and 32° at screening and inclusion visits with an allowed difference of ± 2° between screening and inclusion visits
- 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
- 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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- 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
- 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: Assessment of the Protective Effect of a Sunscreen on Visible Light Induced Pigmentation Using Two Different Simulators, Compared with an Untreated Control Zone
To assess the ability of a protected agent to prevent the pigmentation under visible light exposures (VL) using two different simulators in healthy volunteers
Read the detailed description
The sunscreens usually used as photoprotectors are known to protect in the UV domain (UVB and UVA). However, until recently visible light (400-700 nm) was considered as devoid of any photobiological effects on cutaneous tissue. Over the last two decades, with the development of photodynamic therapies and various dermatological treatments using visible laser light, several studies have reconsidered the cutaneous effect of visible light on the skin, in particular the induction of pigmentation.
This study intends to validate two simulators on visible light exposures with a referent solar formula on visible light protection.
- Being tested
- Visible Light Exposure - Treated zone - Left hemi-back, Visible Light Exposure - Treated zone - Right hemi-back, Visible Light Exposure - Untreated zone - Left hemi-back, Visible Light Exposure - Untreated zone - Right hemi-back
- Keywords
- Photoprotection, Sunscreen, Visible Light (VL), Pigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visible Light Exposure - Treated zone - Left hemi-backOther
The treated zone located on the left side of the hemi-back was exposed to Visible Light with the simulator 1 to induce skin pigmentation (144J/cm2), 15 to 30 minutes after application.
Visible Light Exposure - Treated zone - Right hemi-backOther
The treated zone located on the right side of the hemi-back was exposed to Visible Light with the simulator 2 to induce skin pigmentation (144J/cm2), 15 to 30 minutes after application.
Visible Light Exposure - Untreated zone - Left hemi-backOther
The untreated zone located on the left side of the hemi-back was exposed to Visible Light with the simulator 1 to induce skin pigmentation (144J/cm2), as the same time as the treated zone.
Visible Light Exposure - Untreated zone - Right hemi-backOther
The untreated zone located on the right side of the hemi-back was exposed to Visible Light with the simulator 2 to induce skin pigmentation (144J/cm2), as the same time as the treated zone.
| Study group | Role | What they receive |
|---|---|---|
| Product 1 | The tested product 1 was applied on 2 zones (one zone on each hemi-back), by gentle massage, according to the randomization list, 15 to 30-minutes before the Visible Light exposure. The application was done during 4 consecutive days (From Day 1 to Day 4). Receives: Other: Visible Light Exposure - Treated zone - Left hemi-back; Other: Visible Light Exposure - Treated zone - Right hemi-back | |
| Untreated zone | 2 non-treated control zones (one zone on each hemi-back) Receives: Other: Visible Light Exposure - Untreated zone - Left hemi-back; Other: Visible Light Exposure - Untreated zone - Right hemi-back |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE)
Pigmentation (Delta E - calculated values)
Measured: At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4, Day 5 (24 hours after each Visible Light exposure) and at Day 12.
Secondary outcomes (4)
Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE)
Pigmentation : Individual Typologic Angle (ITA° - calculated value) based on Delta L* and Delta b* - calculated values)
Measured: At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4, Day 5 (24 hours after each Visible Light exposure) and at Day 12.
Clinical investigator's assessment by using clinical scale
Visual scoring of pigmentation, using a pigmentation 14-point scale with 0 (Absence), 1 (Barely visible), 2 (Very pale brown -), 3 (Very pale brown), 4 (Very pale brown +), 5 (Pale brown -), 6 (Pale brown), 7 (Pale brown +), 8 (Brown -), 9 (Brown), 10 (Brown +), 11 (Pronouced brown -), 12 (Pronouced brown), 13 (Pronouced brown +) Visual scoring of erythema, using an erythema 14-point scale with 0 ((Absence), 1 (Barely visible), 2 (Very pale pink -), 3 (Very pale pink), 4 (Very pale pink +), 5 (Pale pink -), 6 (Pale pink), 7 (Pale pink +), 8 (Pink -), 9 (Pink), 10 (Pink +), 11 (Pronouced pink -), 12 (Pronouced pink), 13 (Pronouced pink +)
Measured: At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4, Day 5 (24 hours after each Visible Light exposure) and at Day 12.
Safety and Local Tolerance
Safety was assessed by recording Adverse Events, including cutaneous reactions related to Visible Light exposures or Investigational Product (local intolerance).
Measured: From the informed consent signature date until the end of the study Day 12
Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE)
Erythema (Delta a* - calculated value)
Measured: At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4, Day 5 (24 hours after each Visible Light exposure) and Day 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start8 Mar 2021
- Primary completion9 Apr 2021
- Study completion9 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visible Light Exposures 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
- Other
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796140
- Sponsor's protocol ID
- ACR_VALVI2_21-00740
- Status last verified
- Jan 2025
- First submitted
- 16 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Protective Effect of a Sunscreen on Visible Light Induced Pigmentation Using Two Different Simulators, Compared with an Untreated Control Zone
- ClinicalTrials.gov ID
- NCT06796140
- Acronym / sponsor ID
- ACR_VALVI2_21-00740
- Keywords
- Photoprotection, Sunscreen, Visible Light (VL), Pigmentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 9 Apr 2021 (actual)
- Study completion
- 9 Apr 2021 (actual)
- First posted
- 28 Jan 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.
To assess the ability of a protected agent to prevent the pigmentation under visible light exposures (VL) using two different simulators in healthy volunteers
Detailed description
The sunscreens usually used as photoprotectors are known to protect in the UV domain (UVB and UVA). However, until recently visible light (400-700 nm) was considered as devoid of any photobiological effects on cutaneous tissue. Over the last two decades, with the development of photodynamic therapies and various dermatological treatments using visible laser light, several studies have reconsidered the cutaneous effect of visible light on the skin, in particular the induction of pigmentation.
This study intends to validate two simulators on visible light exposures with a referent solar formula on visible light protection.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Product 1 | – | Other: Visible Light Exposure - Treated zone - Left hemi-back, Other: Visible Light Exposure - Treated zone - Right hemi-backThe tested product 1 was applied on 2 zones (one zone on each hemi-back), by gentle massage, according to the randomization list, 15 to 30-minutes before the Visible Light exposure. The application was done during 4 consecutive days (From Day 1 to Day 4). |
| Untreated zone | – | Other: Visible Light Exposure - Untreated zone - Left hemi-back, Other: Visible Light Exposure - Untreated zone - Right hemi-back2 non-treated control zones (one zone on each hemi-back) |
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 years old with phototype III to IV according to the Fitzpatrick scale and with an ITA° between 18° to 32° at Screening
Key inclusion criteria (11 listed)
- Healthy female or male volunteer from 18 to 50 years old
- Skin type III-IV according to the Fitzpatrick classification
- Average ITA° (Individual Typologic Angle calculated value) on the back between 18° and 32° at screening and inclusion visits with an allowed difference of ± 2° between screening and inclusion visits
- 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
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 |
|---|---|---|
| Visible Light Exposure - Treated zone - Left hemi-backThe treated zone located on the left side of the hemi-back was exposed to Visible Light with the simulator 1 to induce skin pigmentation (144J/cm2), 15 to 30 minutes after application. | Other | Product 1 |
| Visible Light Exposure - Treated zone - Right hemi-backThe treated zone located on the right side of the hemi-back was exposed to Visible Light with the simulator 2 to induce skin pigmentation (144J/cm2), 15 to 30 minutes after application. | Other | Product 1 |
| Visible Light Exposure - Untreated zone - Left hemi-backThe untreated zone located on the left side of the hemi-back was exposed to Visible Light with the simulator 1 to induce skin pigmentation (144J/cm2), as the same time as the treated zone. | Other | Untreated zone |
| Visible Light Exposure - Untreated zone - Right hemi-backThe untreated zone located on the right side of the hemi-back was exposed to Visible Light with the simulator 2 to induce skin pigmentation (144J/cm2), as the same time as the treated zone. | Other | Untreated zone |
Primary outcome
Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE)
Time frame: At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4, Day 5 (24 hours after each Visible Light exposure) and at Day 12.
Pigmentation (Delta E - calculated values)
4 secondary outcomes
Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE)
Time frame: At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4, Day 5 (24 hours after each Visible Light exposure) and at Day 12.
Clinical investigator's assessment by using clinical scale
Time frame: At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4, Day 5 (24 hours after each Visible Light exposure) and at Day 12.
Safety and Local Tolerance
Time frame: From the informed consent signature date until the end of the study Day 12
Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE)
Time frame: At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4, Day 5 (24 hours after each Visible Light exposure) and 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 30 Jan 2025.
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 Exposures on Healthy Back Skin, run by Cosmetique Active International 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 11 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 30 Jan 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?
Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE) (time frame: At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4, Day 5 (24 hours after each Visible Light exposure) and at Day 12.). 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 30 Jan 2025.