Efficacy of Sunscreen ProductsNCT06803901
Evaluation of the Photoprotection Efficacy with Sunscreen Formulas Under Visible Light Exposure
An observational study of Efficacy of Sunscreen Products and 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
- Efficacy of Sunscreen Products, Healthy Back Skin, Pigmentation Induced by Visible Light Exposure
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2019to 22 Mar 2019
- 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: Twenty (20) subjects* were screened and randomized. All completed the study as planned. *Healthy male and female, from 18 to 50 years old, presenting with phototype III to V
Who may be able to join
- Healthy subject of both sexes aged 18 - 50 years old, having a phototype IIIb, IV or V according to Fitzpatrick classification (4),
- Subject with an ITA° (Individual Typologic Angle calculated value) between -20° and 28° at the screening visit,
- Healthy subject based on physical examination and compatibility of medical history with the study content,
- Woman 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 agreeing to continue adequate contraception during the entire duration of the study,
- Woman of non-childbearing potential (menopausal with one year without bleeding, hysterectomy, bilateral ovariectomy),
- Subject having signed a written informed consent form and dated before any study procedure begins.
- Subject willing to actively cooperate during the study duration and willing to complete the study,
- Subject affiliated to the social security system (according to 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 may have interfered 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 had been overexposed to natural (sun) or artificial ultraviolet (tanning lamps) in the last month prior the first visit or who planned a such exposure during the study;
Show all 15Show fewer
- 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 and photosensitising treatment) or any treatment able to induce abnormal response to UV or visible light (vitamin A derivatives, psoralen, aminolevulinic acid..) or having planned to take these treatments during the study,
- Subject 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,
- Subject requiring enhanced protection (deprived of liberty, minors, under guardianship),
- Subject being in a situation which, according to the Investigator, could have interfered 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 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.
- Conditions
- Efficacy of Sunscreen Products, Healthy Back Skin, Pigmentation Induced by Visible Light Exposure
- Keywords
- Photoprotection, Sunscreen, Visible Light (VL), Pigmentation
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). Subjective symptoms (dryness, pruritus and burning sensation) were assessed on 5-point scale from 0-4:
- No symptom
- Minimal symptoms
- Mild symptoms
- Moderate symptoms
- Severe symptoms
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 posted31 Jan 2025
- Study start4 Feb 2019
- Primary completion22 Mar 2019
- Study completion22 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy of Sunscreen ProductsStudies 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
- NCT06803901
- Sponsor's protocol ID
- 18-14124 / CPC-3554
- Status last verified
- Jan 2025
- First submitted
- 14 Jan 2025
- Last updated
- 31 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 31 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
- NCT06803901
- Acronym / sponsor ID
- 18-14124 / CPC-3554
- Conditions
- Efficacy of Sunscreen Products, Healthy Back Skin, Pigmentation Induced by Visible Light Exposure
- 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
- 4 Feb 2019 (actual)
- Primary completion
- 22 Mar 2019 (actual)
- Study completion
- 22 Mar 2019 (actual)
- First posted
- 31 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
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Twenty (20) subjects* were screened and randomized. All completed the study as planned. *Healthy male and female, from 18 to 50 years old, presenting with phototype III to V
Key inclusion criteria (8 listed)
- Healthy subject of both sexes aged 18 - 50 years old, having a phototype IIIb, IV or V according to Fitzpatrick classification (4),
- Subject with an ITA° (Individual Typologic Angle calculated value) between -20° and 28° at the screening visit,
- Healthy subject based on physical examination and compatibility of medical history with the study content,
- Woman 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 agreeing to continue adequate contraception during the entire duration of the study,
- Woman 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 may have interfered with the interpretation of the clinical trial results such as:
- Subject who had been overexposed to natural (sun) or artificial ultraviolet (tanning lamps) in the last month prior the first visit or who planned a 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 and photosensitising treatment) or any treatment able to induce abnormal response to UV or visible light (vitamin A derivatives, psoralen, aminolevulinic acid..) or having planned 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.
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 31 Jan 2025.
- Individual participant dataSharing planned: No
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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 Efficacy of Sunscreen Products and 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 31 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 31 Jan 2025.