Ultraviolet-Induced Change in Normal SkinNCT06068010
UVA Protection Factors of SPF 50 and 50+ Face Sunscreens
An observational study of Ultraviolet-Induced Change in Normal Skin, run by Cosmetique Active International at 6 sites in 4 countries.
Trial summary
The goal of this observational study is to use the International Organization for Standardization (ISO) 24442:2011 in vivo method for assessment of the Ultraviolet A Protection Factor (UVAPF) of topical sunscreen products in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ultraviolet-Induced Change in Normal Skin
- How many people
- 412 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 20 Apr 2018to 15 Dec 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: adults meeting the inclusion and exclusion criteria and willing to adhere to the protocol and study procedures
Who may be able to join
- Fitzpatrick skin phototype: II, III or IV
- colorimetric Individual Typology Angle (ITA°): 20° to 41°
- intact skin on test site
Who cannot join
- pregnant or lactating women
- subjects using medication with photo-sensitizing potential
- subjects receiving chemotherapy or radiotherapy
- subjects who have had UV exposure on the back area in the four weeks prior to UVAPF testing
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
About this study
The goal of this observational study is to use the International Organization for Standardization (ISO) 24442:2011 in vivo method for assessment of the Ultraviolet A Protection Factor (UVAPF) of topical sunscreen products in healthy adults. The main question it aims to answer is to determine the degree of UVA-protection against UVA radiation.
An area of each subject's skin is exposed to UVA light without any protection and another (different) area is exposed after application of the sunscreen product under test. One further area is exposed after application of a reference UVA sunscreen formulation (S2), which is used to validate the procedure.
Read the detailed description
The objective of the study conducted in accordance with the Declaration of Helsinki and national regulations regarding human studies is to evaluate the UVA protection factor of the investigational products against UVA, according to the ISO 24442:2011 methodology comparatively to a standard product (Standard S2) in healthy adult subjects.
Standard reference S2 sunscreen formula is used in a study if any test sample has an expected UVAPF of 12 or above. The mean UVAPF for the reference sample S2 is 12,7. The test result of the reference S2 UVAPF must be between 10,7 and 14,7 or the test is invalid and shall be repeated. The reference S2 may be used to validate any product test.
In order to determine the number of subjects, the 95 % confidence interval (CI) shall be taken into account. The 95 % confidence interval should lie within ±17 % of the mean UVAPF, and a minimum of 10 subjects is required.
- Keywords
- sunscreen, UVA protection, ISO 24442:2011, photoprotection
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the protection factor of the investigational product against UVA
The UVAPF test method uses persistent pigment darkening (PPD) responses of the skin as the end point for evaluating transmitted UVA radiation. The test is restricted to the area of the back of selected human subjects. An area of each subject's skin is exposed to UVA light without any protection and another (different) area is exposed after application of the sunscreen product under test. One further area is exposed after application of a reference UVA sunscreen formulation (S2), which is used to validate the procedure.
To determine the UVAPF, incremental series of UVA exposures are delivered to five or six small sub-sites on the skin to induce darkening responses. These responses are visually assessed for pigment darkness 2 h to 24 h after UVA exposure, by the judgement of a trained evaluator.
Measured: from baseline to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start20 Apr 2018
- Primary completion15 Dec 2020
- Study completion15 Dec 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 Ultraviolet-Induced Change in Normal 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caroline Le Floc'h, Study director, Cosmetique Active International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068010
- Sponsor's protocol ID
- LRP20005-face sunscreens
- Status last verified
- Oct 2023
- First submitted
- 28 Sep 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Young A, Tricaud C, Bernerd F, Yuan Y, Renoux P, Sensenbrenner M, Demessant AL, Floc'h CL, Josso M, Andres P. In Vivo Measurement of UVA Protection Factor (ISO 24442:2011) Across 38 Different SPF 50 and SPF 50+ Sunscreens Reveals High Heterogeneity and Limitations in the Level of Protection. Photodermatol Photoimmunol Photomed. 2026 May;42(3):e70092. doi: 10.1111/phpp.70092.
PubMed 41968398
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UVA Protection Factors of SPF 50 and 50+ Face Sunscreens
- ClinicalTrials.gov ID
- NCT06068010
- Acronym / sponsor ID
- LRP20005-face sunscreens
- Keywords
- sunscreen, UVA protection, ISO 24442:2011, photoprotection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 5 Oct 2023 (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 observational study is to use the International Organization for Standardization (ISO) 24442:2011 in vivo method for assessment of the Ultraviolet A Protection Factor (UVAPF) of topical sunscreen products in healthy adults. The main question it aims to answer is to determine the degree of UVA-protection against UVA radiation.
An area of each subject's skin is exposed to UVA light without any protection and another (different) area is exposed after application of the sunscreen product under test. One further area is exposed after application of a reference UVA sunscreen formulation (S2), which is used to validate the procedure.
Detailed description
The objective of the study conducted in accordance with the Declaration of Helsinki and national regulations regarding human studies is to evaluate the UVA protection factor of the investigational products against UVA, according to the ISO 24442:2011 methodology comparatively to a standard product (Standard S2) in healthy adult subjects.
Standard reference S2 sunscreen formula is used in a study if any test sample has an expected UVAPF of 12 or above. The mean UVAPF for the reference sample S2 is 12,7. The test result of the reference S2 UVAPF must be between 10,7 and 14,7 or the test is invalid and shall be repeated. The reference S2 may be used to validate any product test.
In order to determine the number of subjects, the 95 % confidence interval (CI) shall be taken into account. The 95 % confidence interval should lie within ±17 % of the mean UVAPF, and a minimum of 10 subjects is required.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adults meeting the inclusion and exclusion criteria and willing to adhere to the protocol and study procedures
Key inclusion criteria (3 listed)
- Fitzpatrick skin phototype: II, III or IV
- colorimetric Individual Typology Angle (ITA°): 20° to 41°
- intact skin on test site
Key exclusion criteria (4 listed)
- pregnant or lactating women
- subjects using medication with photo-sensitizing potential
- subjects receiving chemotherapy or radiotherapy
- subjects who have had UV exposure on the back area in the four weeks prior to UVAPF testing
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
Evaluate the protection factor of the investigational product against UVA
Time frame: from baseline to 24 hours
The UVAPF test method uses persistent pigment darkening (PPD) responses of the skin as the end point for evaluating transmitted UVA radiation. The test is restricted to the area of the back of selected human subjects. An area of each subject's skin is exposed to UVA light without any protection and another (different) area is exposed after application of the sunscreen product under test. One further area is exposed after application of a reference UVA sunscreen formulation (S2), which is used to validate the procedure. To determine the UVAPF, incremental series of UVA exposures are delivered to five or six small sub-sites on the skin to induce darkening responses. These responses are visually assessed for pigment darkness 2 h to 24 h after UVA exposure, by the judgement of a trained evaluator.
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 6 Oct 2023.
- Derived from this study: PubMed 41968398Young A, Tricaud C, Bernerd F, Yuan Y, Renoux P, Sensenbrenner M, Demessant AL, Floc'h CL, Josso M, Andres P. In Vivo Measurement of UVA Protection Factor (ISO 24442:2011) Across 38 Different SPF 50 and SPF 50+ Sunscreens Reveals High Heterogeneity and Limitations in the Level of Protection. Photodermatol Photoimmunol Photomed. 2026 May;42(3):e70092. doi: 10.1111/phpp.70092.
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Recruiting
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Skin Cancer, Heat Tolerance
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.
Caroline Le Floc'h study director
Cosmetique Active International
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultraviolet-Induced Change in Normal Skin, run by Cosmetique Active International at 6 sites in 4 countries.
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 3 inclusion and 4 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 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Brazil, Poland, 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?
Evaluate the protection factor of the investigational product against UVA (time frame: from baseline to 24 hours). 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 NCT06068010, 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 6 Oct 2023.