Sun Damaged SkinNCT05926791
Photoprotective Effects of a SPF50+ Sunscreen on Skin Genotoxicity Induced by Repeated Chronic Outdoor Sun Exposure
An observational study of Sun Damaged Skin, run by Pierre Fabre Dermo Cosmetique at 1 site in France.
Trial summary
Between 2 and 3 million non-melanoma skin cancers and 132,000 melanoma skin cancers occur globally each year. Sun protection continues to be a major public health issue and has always been a priority research area for Pierre Fabre laboratories. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Sun Damaged Skin
- What is being tested?
- Cosmetic product
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jun 2021to 13 Sep 2021
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects will be recruited from the investigation centre's panel. The participants will be selected on the basis of inclusion and non-inclusion criteria specific to the study and on their ability to comply with the constraints required by the protocol. The participants will be definitely included in the study after a specific interview and a clinical examination
Who may be able to join
- Male or female adults aged between 18 and 55 years included
- Subject with a habit of using little or no sunscreen products with low protection index (SPF < 25) during sun exposure.
- Subject's commitment to have a self-reported sun exposure of at least 3 hours per day for the 5 days of their last week of vacation
- Subjects agreeing not to expose themselves to UVs (natural or artificial) before the planned outdoor sun exposure period
Who cannot join
- - Criteria related to the population:
- Smoker of more than 10 cigarettes per day containing nicotine, paper and/or electronic cigarette equivalent
- Subject having received on study areas artificial UV exposure or excessive, prolonged, and unprotected exposure to natural sunlight within the 4 weeks before the inclusion visit or planning one during the study
- Subject having performed excessive and prolonged physical activity (e.g. trail, long distance running, race…) within 7 days before the inclusion visit
- - Criteria related to the diseases / skin condition:
- Subject with a known history of photosensitivity (toxic, allergic)
Show all 14Show fewer
- Subject with a known personal or family history of skin cancer
- Subject having hereditary or acquired disorders of hemostasis.
- - Criteria related to the treatments and/or products:
- Physical treatment (radiotherapy, phototherapy, chemical peeling, laser, ...) on the study area within 4 weeks before the inclusion visit or planned during the study.
- Systemic or topical treatment applied on the study area (e.g. anti-allergic, anti-inflammatory treatment) within two weeks before the inclusion visit, ongoing or planned during the study and likely to interfere with the study according to the investigator's assessment
- Use of anti-aging products (containing retinoids and / or α-hydroxy acids) on the target areas (face and/or forearms) in the 2 weeks before the inclusion visit.
- Systemic or topical treatment with photosensitizing or phototoxic potential (NSAIDs, antihistamines, psychotropic drugs, antidepressants, anti-migraine drugs, cyclines, quinolone, antibiotics, beta-blockers, etc.), taken or applied to the study area within the previous weeks, ongoing or planned during the study, and likely to interfere with the study according to the investigator's assessment
- Subject taking creatine dietary supplements and/or practicing prolonged fasting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Photoprotective Effects of a SPF50+ Sunscreen on Photo-induced Cell Damage in Epidermal and Urine Samples, Following a Repeated Chronic Outdoor Sun Exposure in Healthy Adults
Between 2 and 3 million non-melanoma skin cancers and 132,000 melanoma skin cancers occur globally each year. Sun protection continues to be a major public health issue and has always been a priority research area for Pierre Fabre laboratories. The involvement of ultraviolet radiation of the solar spectrum in skin carcinogenesis is well known, through its ability to damage the DNA of skin cells and the induction of oxidative processes.
The aim of this exploratory study is to perform the quantification of:
Read more
- DNA photoproducts excised from the genome by the biological repair systems in urine samples
- cellular DNA damage in the epidermis following chronic exposure to natural sunlight.
This study will allow us to better understand and quantify the benefit of sunscreens on photoinduced cellular damage and their elimination in urine.
Read the detailed description
This trial is a monocentric, exploratory, randomized, controlled, open-label, parallel-group study conducted in healthy adult subjects.
The target population consists of subjects who are accustomed to using few products or using low protection index during sun exposure.
The study area is the whole body for sun exposure. The target areas are the face and forearms for the samplings and measurements.
In this design, in order not to impose any strong constraint to the subjects in terms of sun exposure, the duration of the exposure period is left free and can vary between 5 and 21 days. Within this window, subjects can freely determine their sun exposure episodes (choice of time slot, number and duration). However, subjects have to expose themselves for at least 3 hours /day, for 5 days in the week prior to visit 2 (which will be scheduled no more than 3 days after their last sun exposure).
The study includes 3 visits:
- Visit 1: Inclusion (D1)
- Visit 2: Intermediate visit (D7 to D39)
- Visit 3: Wound healing evaluation and end of study (V2 + 15 days +/- 2 days)
The period of outdoor sun exposure varies between 5 and 21 days depending on the duration planned by the subjects themselves. This is also the duration of application of the investigational product for the subjects in group 1.
Visit 1 can be performed up to 15 days before the beginning of the sun exposure period and visit 2 up to 3 days after the last sun exposure.
The duration of participation for a subject varies between 20 and 56 days (from inclusion to the end of the study).
- Conditions
- Sun Damaged Skin
- Being tested
- Cosmetic product
- Keywords
- Sunscreen, Chromametry and pigmentation, Suction blister, Liquid chromatography-High resolution Mass spectrometry, Mass spectrometry lipid analysis, Urine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosmetic productOther
The educated group receives the cosmetic product SPF50+ according to the randomization list established at V1 and returns the products at V2
| Study group | Role | What they receive |
|---|---|---|
| Educated group with product | Subjects receiving the SPF50+ sunscreen product and a targeted educational action
* Route of administration: Topical
* Application duration: from 5 up to 21 days
* Application modalities: The investigational product will be applied during the outdoor sun exposure on all exposed parts of the body (face and body). The investigational product will be applied in sufficient amount to cover the exposed areas (2mg/cm2 recommended), 15 to 30 minutes before each sun exposure. The product should be reapplied as many times as required during sun exposure (systematic reapplication of the product after sweating and/or swimming and/or wiping). Receives: Other: Cosmetic product | |
| Control group | Subjects receiving neither product nor targeted education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in photoinduced DNA damage products in urine samples before and after outdoor sun exposure
Quantitative analysis of photoinduced DNA damage products by high performance liquid chromatography-coupled to tandem Mass Spectrometry (HPLC/MS-MS)
Measured: Change from baseline (day 1) to visit 2 (occuring between day 7 to 39 depending on the duration of sun exposure)
Number of CPD (Cyclobutane Pyrimidine Dimer) lesions in epidermal samples collected from the forearm following the outdoor sun exposure period
Number of CPD (Cyclobutane Pyrimidine Dimer) lesions in epidermal samples by high performance liquid chromatography-coupled to tandem Mass Spectrometry (HPLC/MS-MS)
Measured: Day 7 to 39 (depending on the duration of sun exposure)
Change in colorimetric parameters before and after outdoor sun exposure
Colorimetric parameters assessed by chromametry on the face and forearm
Measured: Change from baseline (day 1) to visit 2 (between day 7 to 39 depending on the duration of sun exposure)
Change in pigmentation parameters before and after outdoor sun exposure
Pigmentation parameters assessed by Multispectral analysis on the face and forearms
Measured: Change from baseline (day 1) to visit 2 (between day 7 to 39 depending on the duration of sun exposure)
Change in cellular damages before and after outdoor sun exposure
Cellular damage assessed by Mass spectrometry lipid analysis in D-Squame samples collected on the face and forearm before and after outdoor sun exposure
Measured: Change from baseline (day 1) to visit 2 (between day 7 to 39 depending on the duration of sun exposure) up to visit 3 ( between day 20 to 56)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start28 Jun 2021
- Primary completion13 Sep 2021
- Study completion13 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sun Damaged 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926791
- Sponsor's protocol ID
- DNAOUTDOOR
- Status last verified
- Jun 2023
- First submitted
- 12 Jan 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Photoprotective Effects of a SPF50+ Sunscreen on Photo-induced Cell Damage in Epidermal and Urine Samples, Following a Repeated Chronic Outdoor Sun Exposure in Healthy Adults
- ClinicalTrials.gov ID
- NCT05926791
- Acronym / sponsor ID
- DNAOUTDOOR
- Conditions
- Sun Damaged Skin
- Keywords
- Sunscreen, Chromametry and pigmentation, Suction blister, Liquid chromatography-High resolution Mass spectrometry, Mass spectrometry lipid analysis, Urine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 13 Sep 2021 (actual)
- Study completion
- 13 Sep 2021 (actual)
- First posted
- 3 Jul 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.
Between 2 and 3 million non-melanoma skin cancers and 132,000 melanoma skin cancers occur globally each year. Sun protection continues to be a major public health issue and has always been a priority research area for Pierre Fabre laboratories. The involvement of ultraviolet radiation of the solar spectrum in skin carcinogenesis is well known, through its ability to damage the DNA of skin cells and the induction of oxidative processes.
The aim of this exploratory study is to perform the quantification of:
- DNA photoproducts excised from the genome by the biological repair systems in urine samples
- cellular DNA damage in the epidermis following chronic exposure to natural sunlight.
This study will allow us to better understand and quantify the benefit of sunscreens on photoinduced cellular damage and their elimination in urine.
Detailed description
This trial is a monocentric, exploratory, randomized, controlled, open-label, parallel-group study conducted in healthy adult subjects.
The target population consists of subjects who are accustomed to using few products or using low protection index during sun exposure.
The study area is the whole body for sun exposure. The target areas are the face and forearms for the samplings and measurements.
In this design, in order not to impose any strong constraint to the subjects in terms of sun exposure, the duration of the exposure period is left free and can vary between 5 and 21 days. Within this window, subjects can freely determine their sun exposure episodes (choice of time slot, number and duration). However, subjects have to expose themselves for at least 3 hours /day, for 5 days in the week prior to visit 2 (which will be scheduled no more than 3 days after their last sun exposure).
The study includes 3 visits:
- Visit 1: Inclusion (D1)
- Visit 2: Intermediate visit (D7 to D39)
- Visit 3: Wound healing evaluation and end of study (V2 + 15 days +/- 2 days)
The period of outdoor sun exposure varies between 5 and 21 days depending on the duration planned by the subjects themselves. This is also the duration of application of the investigational product for the subjects in group 1.
Visit 1 can be performed up to 15 days before the beginning of the sun exposure period and visit 2 up to 3 days after the last sun exposure.
The duration of participation for a subject varies between 20 and 56 days (from inclusion to the end of the study).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educated group with product | – | Other: Cosmetic productSubjects receiving the SPF50+ sunscreen product and a targeted educational action * Route of administration: Topical * Application duration: from 5 up to 21 days * Application modalities: The investigational product will be applied during the outdoor sun exposure on all exposed parts of the body (face and body). The investigational product will be applied in sufficient amount to cover the exposed areas (2mg/cm2 recommended), 15 to 30 minutes before each sun exposure. The product should be reapplied as many times as required during sun exposure (systematic reapplication of the product after sweating and/or swimming and/or wiping). |
| Control group | – | –Subjects receiving neither product nor targeted education |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects will be recruited from the investigation centre's panel. The participants will be selected on the basis of inclusion and non-inclusion criteria specific to the study and on their ability to comply with the constraints required by the protocol. The participants will be definitely included in the study after a specific interview and a clinical examination
Key inclusion criteria (4 listed)
- Male or female adults aged between 18 and 55 years included
- Subject with a habit of using little or no sunscreen products with low protection index (SPF < 25) during sun exposure.
- Subject's commitment to have a self-reported sun exposure of at least 3 hours per day for the 5 days of their last week of vacation
- Subjects agreeing not to expose themselves to UVs (natural or artificial) before the planned outdoor sun exposure period
Key exclusion criteria (14 listed)
- - Criteria related to the population:
- - Criteria related to the diseases / skin condition:
- - Criteria related to the treatments and/or products:
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 |
|---|---|---|
| Cosmetic productThe educated group receives the cosmetic product SPF50+ according to the randomization list established at V1 and returns the products at V2 | Other | Educated group with product |
Primary outcome
Change in photoinduced DNA damage products in urine samples before and after outdoor sun exposure
Time frame: Change from baseline (day 1) to visit 2 (occuring between day 7 to 39 depending on the duration of sun exposure)
Quantitative analysis of photoinduced DNA damage products by high performance liquid chromatography-coupled to tandem Mass Spectrometry (HPLC/MS-MS)
Number of CPD (Cyclobutane Pyrimidine Dimer) lesions in epidermal samples collected from the forearm following the outdoor sun exposure period
Time frame: Day 7 to 39 (depending on the duration of sun exposure)
Number of CPD (Cyclobutane Pyrimidine Dimer) lesions in epidermal samples by high performance liquid chromatography-coupled to tandem Mass Spectrometry (HPLC/MS-MS)
Change in colorimetric parameters before and after outdoor sun exposure
Time frame: Change from baseline (day 1) to visit 2 (between day 7 to 39 depending on the duration of sun exposure)
Colorimetric parameters assessed by chromametry on the face and forearm
Change in pigmentation parameters before and after outdoor sun exposure
Time frame: Change from baseline (day 1) to visit 2 (between day 7 to 39 depending on the duration of sun exposure)
Pigmentation parameters assessed by Multispectral analysis on the face and forearms
Change in cellular damages before and after outdoor sun exposure
Time frame: Change from baseline (day 1) to visit 2 (between day 7 to 39 depending on the duration of sun exposure) up to visit 3 ( between day 20 to 56)
Cellular damage assessed by Mass spectrometry lipid analysis in D-Squame samples collected on the face and forearm before and after outdoor sun 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 3 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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 Sun Damaged Skin, run by Pierre Fabre Dermo Cosmetique 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 4 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 3 Jul 2023. 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?
Change in photoinduced DNA damage products in urine samples before and after outdoor sun exposure (time frame: Change from baseline (day 1) to visit 2 (occuring between day 7 to 39 depending on the duration of sun exposure)). The study lists 5 primary outcomes in all. 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 3 Jul 2023.