Study the Protection Potency of Sunscreen Products Against Pigmentation Induced by Visible Light Exposure on Healthy Back SkinNCT06796192
Evaluate the Photoprotection Efficacy of Sunscreen Formulas Under Visible Light Exposure
An observational study of Study the Protection Potency of Sunscreen Products Against 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 Protection Potency of Sunscreen Products Against Pigmentation Induced by Visible Light Exposure on Healthy Back Skin
- What is being tested?
- Visible Light Exposure - Treated zones and Visible Light Exposure - Untreated zone
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2017to 7 Jul 2017
- 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
Who may be able to join
- Healthy subject of both sexes, aged from 18 to 50 years, of phototype IIIb, IV or V on the Fitzpatrick scale (1988),
- Subject in good health having normal results for the physical examination and a medical antecedents compatible with the study requirements,
- Female subject of childbearing potential using a reliable means of contraception (contraceptive pill, contraceptive implant, IUD, bilateral tubal ligature/section, condoms) and accepting to not change her contraceptive status from at least one month prior to the start of the study and throughout the entire duration of the study,
- Female subject of non-childbearing potential, that was post-menopause (one year without menstruation), hysterectomy or bilateral ovariectomy,
- Subject having signed and dated the informed consent form before any study related action was initiated,
- Subject who was willing to follow the study procedures and to complete the study course,
- Subject affiliated to or beneficiary to a social security scheme (according to French legislation: Law 2004-806 and its implementing decree n°2006-477 of 26 April 2006).
Who cannot join
- Female who was pregnant or breastfeeding or who planned to become pregnant during the study,
- Subjects with an underlying pathology, or with a surgical, physical or medical status which, according to the investigator, could have interfered with the interpretation of the study results such as:
- Dermatological antecedents (e.g. acne, psoriasis, eczema, urticaria, etc.) or suspicion/antecedents of allergies to cosmetics,
- All systemic or local pathologies,
- Skin anomalies (scars, excessive hair, tattooing, etc.) on the test zones (back, middle section).
- Subjects having been excessively exposed to ultraviolet radiation (UV) natural (sun) or artificial (tanning salon) 2 months before the initial visit or who plans such an exposure during the study,
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- Subjects having antecedents or currently presenting pathologies induced or aggravated by exposure to light or abnormal reactions to sunlight (e.g. : photosensitive dermatitis, polymorphous light reaction, benign summer light reaction, solar urticaria, systemic lupus erythematosus,dermatomyositis …),.
- Subjects having taken a systemic treatment for more than 5 days during the month preceding inclusion (steroids, non-steroidal anti-inflammatories such as aspirin, insulin, antihistamines, antihypertensives, antibiotics such as quinolones, tetracyclines, thiazides and fluoroquinolones, and all other photosensitising treatments) or all other treatments capable of inducing an abnormal response to UV or visible light (vitamin A derivatives, psoralen, aminolevulinic acid derivatives…) or planning 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 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 Effect of Three Sunscreens 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
- Visible Light Exposure - Treated zones, Visible Light Exposure - Untreated zone
- 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 zonesOther
The treated zones were exposed to Visible Light to induce skin pigmentation (144J/cm2), 15 minutes after application.
Visible Light Exposure - Untreated zoneOther
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 |
|---|---|---|
| Product 1 | The test product 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: Visible Light Exposure - Treated zones | |
| Product 2 | The test product 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: Visible Light Exposure - Treated zones | |
| Product 3 | The test product 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: Visible Light Exposure - Treated zones | |
| Untreated zone | non-treated control zone Receives: Other: Visible Light Exposure - Untreated zone |
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), • Pigmentation (Delta E, Delta L* and Delta b* - calculated values), • 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 at Day 12..
Secondary outcomes (2)
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
Safety was assessed by recording Adverse Events, including cutaneous reactions (local intolerance) assessed using the following 5-point score system:
0 (no sign/symptom of local intolerance); 0.5 (doubtful sign/symptom of local intolerance); 1 (mild sign/symptom of local intolerance); 2 (moderate sign/symptom of local intolerance); 3 (severe sign/symptom of local intolerance)
Measured: From the informed consent signature date until the end of the study (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 start7 Jun 2017
- Primary completion7 Jul 2017
- Study completion7 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Study the Protection Potency of Sunscreen Products Against 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
- NCT06796192
- Sponsor's protocol ID
- EV1705-0432
- Status last verified
- Jan 2025
- First submitted
- 14 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
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 Effect of Three Sunscreens on Visible Light Induced Pigmentation Compared with an Untreated Control Zone
- ClinicalTrials.gov ID
- NCT06796192
- Acronym / sponsor ID
- EV1705-0432
- 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
- 7 Jun 2017 (actual)
- Primary completion
- 7 Jul 2017 (actual)
- Study completion
- 7 Jul 2017 (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 |
|---|---|---|
| Product 1 | – | Other: Visible Light Exposure - Treated zonesThe test product 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). |
| Product 2 | – | Other: Visible Light Exposure - Treated zonesThe test product 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). |
| Product 3 | – | Other: Visible Light Exposure - Treated zonesThe test product 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: Visible Light Exposure - Untreated zonenon-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
Key inclusion criteria (7 listed)
- Healthy subject of both sexes, aged from 18 to 50 years, of phototype IIIb, IV or V on the Fitzpatrick scale (1988),
- Subject in good health having normal results for the physical examination and a medical antecedents compatible with the study requirements,
- Female subject of childbearing potential using a reliable means of contraception (contraceptive pill, contraceptive implant, IUD, bilateral tubal ligature/section, condoms) and accepting to not change her contraceptive status from at least one month prior to the start of the study and throughout the entire duration of the study,
- Female subject of non-childbearing potential, that was post-menopause (one year without menstruation), hysterectomy or bilateral ovariectomy,
- Subject having signed and dated the informed consent form before any study related action was initiated,
Key exclusion criteria (14 listed)
- Female who was pregnant or breastfeeding or who planned to become pregnant during the study,
- Subjects with an underlying pathology, or with a surgical, physical or medical status which, according to the investigator, could have interfered with the interpretation of the study results such as:
- Subjects having been excessively exposed to ultraviolet radiation (UV) natural (sun) or artificial (tanning salon) 2 months before the initial visit or who plans such an exposure during the study,
- Subjects having antecedents or currently presenting pathologies induced or aggravated by exposure to light or abnormal reactions to sunlight (e.g. : photosensitive dermatitis, polymorphous light reaction, benign summer light reaction, solar urticaria, systemic lupus erythematosus,dermatomyositis …),.
- Subjects having taken a systemic treatment for more than 5 days during the month preceding inclusion (steroids, non-steroidal anti-inflammatories such as aspirin, insulin, antihistamines, antihypertensives, antibiotics such as quinolones, tetracyclines, thiazides and fluoroquinolones, and all other photosensitising treatments) or all other treatments capable of inducing an abnormal response to UV or visible light (vitamin A derivatives, psoralen, aminolevulinic acid derivatives…) or planning 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 |
|---|---|---|
| Visible Light Exposure - Treated zonesThe treated zones were exposed to Visible Light to induce skin pigmentation (144J/cm2), 15 minutes after application. | Other | Product 1, Product 2, Product 3 |
| Visible Light Exposure - Untreated zoneThe 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, Day 5 (24 hours after each Visible Light exposure) and at Day 12..
Individual Typologic Angle (ITA° - calculated value), • Pigmentation (Delta E, Delta L* and Delta b* - calculated values), • Erythema (Delta a* - calculated value).
2 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 until the end of the study (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 28 Jan 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 Study the Protection Potency of Sunscreen Products Against 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 7 inclusion and 14 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, 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 28 Jan 2025.