Study the Potency of Sunscreen to Protect Against the Pigmentation Induced by Visible Light Exposure on Healthy Back SkinNCT06796088
Evaluate the Photoprotection Efficiency of Sunscreen Formulas Under Visible Light Exposure
An observational study of Study the Potency of Sunscreen to Protect Against the Pigmentation Induced by Visible Light Exposure on Healthy Back Skin, run by Cosmetique Active International at 1 site in France.
Trial summary
To evaluate the protective effect of three sunscreens on the pigmentation caused by visible light in comparison to an untreated control zone 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
- Study the Potency of Sunscreen to Protect Against the Pigmentation Induced by Visible Light Exposure on Healthy Back Skin
- What is being tested?
- Treated zones exposed to Visible Light source and Untreated zone exposed to Visible Light source
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 23 Sep 2020to 29 Oct 2020
- 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 V according to the Fitzpatrick scale, with a ITA° betwwen -20° and 28° at screening
Who may be able to join
- Healthy subjects of both sexes aged 18 - 50 years old, having a phototype IIIb, IV or V according to Fitzpatrick classification,
- Subject with an ITA° (Individual Typologic Angle calculated value) between -20° and 28° at the screening visit,
- Healthy subjects based on physical examination and compatibility of medical history with the study content,
- Women of childbearing potential using adequate contraception (oral contraception, intra-uterine devices, contraceptive implants or vaginal rings, tubal sections or ligations, condoms) for at least 1 month prior to first visit and agree to continue adequate contraception during the entire duration of the study,
- Women of non-childbearing potential (menopausal with one year without bleeding, hysterectomy, bilateral ovariectomy),
- Subjects having signed a written informed consent form and dated before any study procedure began.
- Subjects willing to actively cooperate during the study duration and willing to complete the study,
- Subject affiliated to the social security system (in accordance with the French Law 2004-806 and its implementing decree n°2006-477 of 26 April 2006).
Who cannot join
- Female who was pregnant or breast feeding or planning a pregnancy during the study,
- Subject having an underlying known disease, or surgical, physical, or medical condition that, in the opinion of the Investigator could interfere with the interpretation of the clinical trial results such as:
- History of recurrent dermatologic conditions (e.g., psoriasis, eczema, urticaria…) or suspicion/history of allergy to cosmetics,
- Any systemic or local disease pathology
- Skin abnormality (scars, excessive hair, tattoos…) at the level of the test zones (middle part of the back),
- Subject who was overexposed to natural (sun) or artificial ultraviolet (tanning lamps) in the last month prior the first visit or who planneda such exposure during the study;
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- Subject having history or presenting pathologies induced or aggravated by sun exposure or having abnormal reactions to the sun (ex : photosensitive dermatitis, polymorphic light eruption, solar urticaria, systemic erythematous lupus, dermatomyositis),
- Subject having taken a systemic treatment more than 5 days in the month preceding the inclusion (steroids, nonsteroidal anti-inflammatory drugs such as aspirin, antihistamine, insulin, hypertensors, antibiotics such as quinolones, tetracyclins, thiazids, fluoroquinolons and photosensitising treatment) or any treatment able to induce abnormal response to UV or visible light (vitamin A derivatives, psoralen, aminolevulinic acid etc.) or having plane to take these treatments during the study,
- Subjects having applied a local treatment on the back for more than 2 days during the 2 weeks preceding inclusion (steroids, non-steroidal anti-inflammatories, antihistamines, antibiotics) and all other cosmetic products in the previous 24 hours,
- Subject having antecedents of clinically significant allergy, particularly to study product components,
- Subjects requiring enhanced protection (deprived of liberty, minors, under guardianship),
- Subject being in a situation which, according to the Investigator, could interfere with an optimal participation in the study,
- Subject currently participating or having participated in another clinical trial during the month preceding inclusion,
- Subject under care of guardian or legal guardianship or subject hospitalized in a medical or social establishment for any reason,
- Subject unable to communicate efficiently with the Investigator or being unable to follow the study requirements.
Trial locations and contacts
1 site in 1 country.
France1 site
CPCAD (Centre de Pharmacologie Clinique Appliquée à la Dermatologie)
Nice, 06202
About this study
Official title: Assessment of the Protective Effects of Three Sunscreen Products on Visible Light Induced Pigmentation Compared with an Untreated Control Zone
To evaluate the protective effect of three sunscreens on the pigmentation caused by visible light in comparison to an untreated control zone 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.
The aim of this study was to assess the ability of sunscreens with a protective efficacy in the UV domain to prevent the pigmentation induced by Visible Light.
- Being tested
- Treated zones exposed to Visible Light source, Untreated zone exposed to Visible Light source
- 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.
Treated zones exposed to Visible Light sourceOther
The treated zones were exposed to Visible Light to induce skin pigmentation (144J/cm2), 15 to 30 minutes after application.
Untreated zone exposed to Visible Light sourceOther
The untreated zone was exposed to Visible Light to induce skin pigmentation (144J/cm2), as the same time as the treated zones.
| Study group | Role | What they receive |
|---|---|---|
| Sunscreen 1 | The test sunscreen 1 was applied (2 mg/cm²) on the attributed zone according to the randomization list. The application was done during 4 consecutive days (From Day 1 to Day 4). Receives: Other: Treated zones exposed to Visible Light source | |
| Sunscreen 2 | The test sunscreen 2 was applied (2 mg/cm²) on the attributed zone according to the randomization list. The application was done during 4 consecutive days (From Day 1 to Day 4). Receives: Other: Treated zones exposed to Visible Light source | |
| Sunscreen 3 | The test sunscreen 3 was applied (2 mg/cm²) on the attributed zone according to the randomization list. The application was done during 4 consecutive days (From Day 1 to Day 4). Receives: Other: Treated zones exposed to Visible Light source | |
| Untreated zone | non-treated control zone Receives: Other: Untreated zone exposed to Visible Light source |
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)
Individual Typologic Angle (ITA° - calculated value)
Measured: At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4 and Day 5 (24 hours after each Visible Light exposure).
Secondary outcomes (4)
Clinical investigator's assessment by using clinical scale
Visual scoring of pigmentation, using a pigmentation 11-point scale with 0 (No pigmentation), 1 (Doubtful), 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 +) Visual scoring of erythema, using an erythema 4-point scale with 0 (Absent), 0.5 (Doubtful), 1 (Weak but well-defined erythema), 2 (Moderate), 3 (Severe)
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 / Local Tolerance
To assess the local tolerance and the overall tolerability of the test products on the basis of undesirable effect reporting and on subjective symptoms (dryness, pruritus and burning sensation) assessed on 5-point scale from 0-4: No symptom (0); Minimal symptoms (1); Mild symptoms (2); Moderate symptoms (3); Severe symptoms (4)
Measured: From the informed consent signature date (Screening visit) 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)
Pigmentation (Delta E, Delta L* and Delta b* - calculated values)
Measured: At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4 and Day 5 (24 hours after each Visible Light exposure).
Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE)
Erythema (Delta a* calculated values)
Measured: At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4 and Day 5 (24 hours after each Visible Light exposure).
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 start23 Sep 2020
- Primary completion29 Oct 2020
- Study completion29 Oct 2020
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 Study the Potency of Sunscreen to Protect Against the Pigmentation Induced by 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
- Other
- Enrolment
- 20 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
- NCT06796088
- Sponsor's protocol ID
- 20-09917 / CPC-3595
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Renoux P, Jouni H, Laloux C, Touti R, Vieu DL, Lamarche F, Santos SM, Bernerd F, Marionnet C. Visible Light-Induced Pigmentation: Improved In Vivo Methodology for Measuring Efficacy of 30 Products in 9 Randomised Controlled Trials and Correlation With In Vitro Assessment. Exp Dermatol. 2025 Sep;34(9):e70167. doi: 10.1111/exd.70167.
PubMed 40922539
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Protective Effects of Three Sunscreen Products on Visible Light Induced Pigmentation Compared with an Untreated Control Zone
- ClinicalTrials.gov ID
- NCT06796088
- Acronym / sponsor ID
- 20-09917 / CPC-3595
- Keywords
- Photoprotection, Sunscreen, Visible Light (VL), Pigmentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 29 Oct 2020 (actual)
- Study completion
- 29 Oct 2020 (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 evaluate the protective effect of three sunscreens on the pigmentation caused by visible light in comparison to an untreated control zone 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.
The aim of this study was to assess the ability of sunscreens with a protective efficacy in the UV domain to prevent the pigmentation induced by Visible Light.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sunscreen 1 | – | Other: Treated zones exposed to Visible Light sourceThe test sunscreen 1 was applied (2 mg/cm²) on the attributed zone according to the randomization list. The application was done during 4 consecutive days (From Day 1 to Day 4). |
| Sunscreen 2 | – | Other: Treated zones exposed to Visible Light sourceThe test sunscreen 2 was applied (2 mg/cm²) on the attributed zone according to the randomization list. The application was done during 4 consecutive days (From Day 1 to Day 4). |
| Sunscreen 3 | – | Other: Treated zones exposed to Visible Light sourceThe test sunscreen 3 was applied (2 mg/cm²) on the attributed zone according to the randomization list. The application was done during 4 consecutive days (From Day 1 to Day 4). |
| Untreated zone | – | Other: Untreated zone exposed to Visible Light sourcenon-treated control zone |
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 V according to the Fitzpatrick scale, with a ITA° betwwen -20° and 28° at screening
Key inclusion criteria (8 listed)
- Healthy subjects of both sexes aged 18 - 50 years old, having a phototype IIIb, IV or V according to Fitzpatrick classification,
- Subject with an ITA° (Individual Typologic Angle calculated value) between -20° and 28° at the screening visit,
- Healthy subjects based on physical examination and compatibility of medical history with the study content,
- Women of childbearing potential using adequate contraception (oral contraception, intra-uterine devices, contraceptive implants or vaginal rings, tubal sections or ligations, condoms) for at least 1 month prior to first visit and agree to continue adequate contraception during the entire duration of the study,
- Women of non-childbearing potential (menopausal with one year without bleeding, hysterectomy, bilateral ovariectomy),
Key exclusion criteria (15 listed)
- Female who was pregnant or breast feeding or planning a pregnancy during the study,
- Subject having an underlying known disease, or surgical, physical, or medical condition that, in the opinion of the Investigator could interfere with the interpretation of the clinical trial results such as:
- Subject who was overexposed to natural (sun) or artificial ultraviolet (tanning lamps) in the last month prior the first visit or who planneda such exposure during the study;
- Subject having history or presenting pathologies induced or aggravated by sun exposure or having abnormal reactions to the sun (ex : photosensitive dermatitis, polymorphic light eruption, solar urticaria, systemic erythematous lupus, dermatomyositis),
- Subject having taken a systemic treatment more than 5 days in the month preceding the inclusion (steroids, nonsteroidal anti-inflammatory drugs such as aspirin, antihistamine, insulin, hypertensors, antibiotics such as quinolones, tetracyclins, thiazids, fluoroquinolons and photosensitising treatment) or any treatment able to induce abnormal response to UV or visible light (vitamin A derivatives, psoralen, aminolevulinic acid etc.) or having plane to take these treatments during 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treated zones exposed to Visible Light sourceThe treated zones were exposed to Visible Light to induce skin pigmentation (144J/cm2), 15 to 30 minutes after application. | Other | Sunscreen 1, Sunscreen 2, Sunscreen 3 |
| Untreated zone exposed to Visible Light sourceThe untreated zone was exposed to Visible Light to induce skin pigmentation (144J/cm2), as the same time as the treated zones. | 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 and Day 5 (24 hours after each Visible Light exposure).
Individual Typologic Angle (ITA° - calculated value)
4 secondary outcomes
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 / Local Tolerance
Time frame: From the informed consent signature date (Screening visit) 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 and Day 5 (24 hours after each Visible Light exposure).
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 and Day 5 (24 hours after each Visible Light exposure).
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 28 Jan 2025.
- Derived from this study: PubMed 40922539Renoux P, Jouni H, Laloux C, Touti R, Vieu DL, Lamarche F, Santos SM, Bernerd F, Marionnet C. Visible Light-Induced Pigmentation: Improved In Vivo Methodology for Measuring Efficacy of 30 Products in 9 Randomised Controlled Trials and Correlation With In Vitro Assessment. Exp Dermatol. 2025 Sep;34(9):e70167. doi: 10.1111/exd.70167.
- 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 Study the Potency of Sunscreen to Protect Against the Pigmentation Induced by Visible Light Exposure on Healthy Back Skin, run by Cosmetique Active International 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 8 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 28 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 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?
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 and Day 5 (24 hours after each Visible Light exposure).). 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 NCT06796088, 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 28 Jan 2025.