Skin PigmentationNCT07537595
Efficacy of Cosmetic Products in Preventing Pigmentation Induced by High Energy Visible Light (HEVL) [400-450nm]
An observational study of Skin Pigmentation and Healthy Volunteers, run by Cosmetique Active International at 1 site in Romania.
Trial summary
The goal of this double-blind, randomized clinical trial is to evaluate the efficacy of anti-pigmentation cosmetic products in preventing skin pigmentation induced by High Energy Visible Light (HEVL) [400-450nm] in healthy volunteers (male and female, aged 18-60 years, Caucasian, phototypes III-IV). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Pigmentation, Healthy Volunteers, Hyperpigmentation
- What is being tested?
- Treated and exposed zones (cosmetic topical products applied) and Untreated and exposed zone (no product applied)
- How many people
- 33 participants
- Where
- 1 siteRomania
- Study dates
- 10 Jun 2024to 6 Dec 2024
- How long will I take part?
- 7 Weeks
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy male and female volunteers from 18 to 60 yo, with Fitzpatrick III and IV and an ITA° between 18° to 35° at screening.
Who may be able to join
- Caucasian subjects
- Male and female participants
- Aged between 18 and 60 years old
- Skin phototypes III-IV
- Average ITA° on the back between 18° and 35° (± 2°) at screening and baseline/inclusion visit
- Uniform skin color over the eight test zones (difference in ITA° between each zone ≤ 4°)
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- Untanned back (no UV exposure - natural or artificial - during the 2 months prior to inclusion)
- No scar, spot, tattoo or excess hair on investigational zones
- Subject having given written informed consent
- Subjects able to read and understand study documents
- Subjects with an official domicile
- Subject covered by health insurance or social security
- Female subjects of child-bearing potential using a safe method of contraception for at least 3 months prior to and throughout the study
Who cannot join
- Pregnant, lactating, or planning to become pregnant during the study
- Planned UV exposure (sunlight or sunbeds) of investigational zones throughout the study
- Sunbed use or sun exposure of investigational zones within the 3 months prior to inclusion
- Presence of sunburn (erythema) on the back
- Dermatological disorders affecting investigational zones (naevi, freckles, excess hair, uneven skin tone, vitiligo, photodermatological problems)
- History of skin cancer
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- History of abnormal response to sun
- Presence of recent suntan or photo-test marks (per investigator opinion)
- History of allergy, hypersensitivity, or serious reaction to any cosmetic product
- Any concomitant medical condition that may interfere with the study (per investigator opinion)
- Use of systemic medication for more than 5 consecutive days within the month prior to inclusion (e.g., steroids, antihistamines, antibiotics, vitamin A derivatives, psoralen)
- Use of depigmenting, whitening or propigmenting topical treatments within the 3 months prior to inclusion
- Physical treatment including laser or phototherapy (PUVA, IPL, PDT) within the past 6 months on investigational sites
- Planned intensive sport (> 5 hours per week) or swimming during the study
- Participation in another clinical study within 30 days prior to inclusion
- Deprived of liberty by adjunction or official decision
- Unable to be contacted by phone in case of emergency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Anti-pigmentation Agents and/or Filters Under Part of Visible Light [400-450 nm] Exposures
The goal of this double-blind, randomized clinical trial is to evaluate the efficacy of anti-pigmentation cosmetic products in preventing skin pigmentation induced by High Energy Visible Light (HEVL) [400-450nm] in healthy volunteers (male and female, aged 18-60 years, Caucasian, phototypes III-IV).
The main questions it aims to answer are:
Read more
Can anti-pigmentation agents and/or HEV filters reduce HEV light-induced skin pigmentation, as measured by the Individual Typological Angle (Delta ITA°)? Can these products improve additional colorimetric parameters (Delta L*, a*, b*, Delta E) and clinical pigmentation and erythema scores (0-13 scale)? Are these formulations safe and well-tolerated under HEVL exposure? Researchers will compare seven cosmetic formulations (Products A to G) to an untreated exposed control zone to assess their ability to prevent HEVL-induced pigmentation.
Participants will:
Attend 36 visits over 7 weeks Receive standardized product applications (2 mg/cm²) on 7 test zones (3x3 cm) delineated on their back. One test zone will be not treated.
Be exposed to HEVL light [400-450nm] at 35 J/cm² over 4 consecutive days (Days 8-11) Undergo colorimetric measurements and clinical assessments of pigmentation and erythema at 13 time points
- Conditions
- Skin Pigmentation, Healthy Volunteers, Hyperpigmentation
- Being tested
- Treated and exposed zones (cosmetic topical products applied), Untreated and exposed zone (no product applied)
- Keywords
- High Energy Visible Light (HEVL)
- Medical subject headings
- Pigmentation Disorders, Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treated and exposed zones (cosmetic topical products applied)Other
exposed to HEVL source to induce skin pigmentation (35 J/cm²) during 4 consecutive days (from Day 8 to Day 11)
Untreated and exposed zone (no product applied)Other
exposed to HEVL source to induce skin pigmentation (35 J/cm²) during 4 consecutive days (from Day 8 to Day 11)
| Study group | Role | What they receive |
|---|---|---|
| Product A | Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47 Receives: Other: Treated and exposed zones (cosmetic topical products applied) | |
| Product B | Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47 Receives: Other: Treated and exposed zones (cosmetic topical products applied) | |
| Product C | Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47 Receives: Other: Treated and exposed zones (cosmetic topical products applied) | |
| Product D | Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47 Receives: Other: Treated and exposed zones (cosmetic topical products applied) | |
| Product E | Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47 Receives: Other: Treated and exposed zones (cosmetic topical products applied) | |
| Product F | Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47 Receives: Other: Treated and exposed zones (cosmetic topical products applied) | |
| Product G | Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47 Receives: Other: Treated and exposed zones (cosmetic topical products applied) | |
| Control | non treated zone Receives: Other: Untreated and exposed zone (no product applied) |
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 the adjacent 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 erythema 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 posted17 Apr 2026
- Study start10 Jun 2024
- Primary completion6 Dec 2024
- Study completion6 Dec 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
- Target duration
- 7 Weeks
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537595
- Sponsor's protocol ID
- EV2404-0384 / ID24-06795
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 17 Apr 2026
- 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 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Anti-pigmentation Agents and/or Filters Under Part of Visible Light [400-450 nm] Exposures
- ClinicalTrials.gov ID
- NCT07537595
- Acronym / sponsor ID
- EV2404-0384 / ID24-06795
- Conditions
- Skin Pigmentation, Healthy Volunteers, Hyperpigmentation
- Keywords
- High Energy Visible Light (HEVL)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 17 Apr 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 goal of this double-blind, randomized clinical trial is to evaluate the efficacy of anti-pigmentation cosmetic products in preventing skin pigmentation induced by High Energy Visible Light (HEVL) [400-450nm] in healthy volunteers (male and female, aged 18-60 years, Caucasian, phototypes III-IV).
The main questions it aims to answer are:
Can anti-pigmentation agents and/or HEV filters reduce HEV light-induced skin pigmentation, as measured by the Individual Typological Angle (Delta ITA°)? Can these products improve additional colorimetric parameters (Delta L*, a*, b*, Delta E) and clinical pigmentation and erythema scores (0-13 scale)? Are these formulations safe and well-tolerated under HEVL exposure? Researchers will compare seven cosmetic formulations (Products A to G) to an untreated exposed control zone to assess their ability to prevent HEVL-induced pigmentation.
Participants will:
Attend 36 visits over 7 weeks Receive standardized product applications (2 mg/cm²) on 7 test zones (3x3 cm) delineated on their back. One test zone will be not treated.
Be exposed to HEVL light [400-450nm] at 35 J/cm² over 4 consecutive days (Days 8-11) Undergo colorimetric measurements and clinical assessments of pigmentation and erythema at 13 time points
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 7 Weeks
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Product A | – | Other: Treated and exposed zones (cosmetic topical products applied)Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47 |
| Product B | – | Other: Treated and exposed zones (cosmetic topical products applied)Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47 |
| Product C | – | Other: Treated and exposed zones (cosmetic topical products applied)Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47 |
| Product D | – | Other: Treated and exposed zones (cosmetic topical products applied)Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47 |
| Product E | – | Other: Treated and exposed zones (cosmetic topical products applied)Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47 |
| Product F | – | Other: Treated and exposed zones (cosmetic topical products applied)Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47 |
| Product G | – | Other: Treated and exposed zones (cosmetic topical products applied)Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47 |
| Control | – | Other: Untreated and exposed zone (no product applied)non treated zone |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy male and female volunteers from 18 to 60 yo, with Fitzpatrick III and IV and an ITA° between 18° to 35° at screening.
Key inclusion criteria (13 listed)
- Caucasian subjects
- Male and female participants
- Aged between 18 and 60 years old
- Skin phototypes III-IV
- Average ITA° on the back between 18° and 35° (± 2°) at screening and baseline/inclusion visit
Key exclusion criteria (17 listed)
- Pregnant, lactating, or planning to become pregnant during the study
- Planned UV exposure (sunlight or sunbeds) of investigational zones throughout the study
- Sunbed use or sun exposure of investigational zones within the 3 months prior to inclusion
- Presence of sunburn (erythema) on the back
- Dermatological disorders affecting investigational zones (naevi, freckles, excess hair, uneven skin tone, vitiligo, photodermatological problems)
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 |
|---|---|---|
| Treated and exposed zones (cosmetic topical products applied)exposed to HEVL source to induce skin pigmentation (35 J/cm²) during 4 consecutive days (from Day 8 to Day 11) | Other | Product A, Product B, Product C, Product D, Product E, Product F, Product G |
| Untreated and exposed zone (no product applied)exposed to HEVL source to induce skin pigmentation (35 J/cm²) during 4 consecutive days (from Day 8 to Day 11) | Other | Control |
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 the adjacent 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 17 Apr 2026.
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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?
An observational study of Skin Pigmentation and Healthy Volunteers, 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 13 inclusion and 17 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 17 Apr 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 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?
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 17 Apr 2026.