SunscreenNCT05837208
Determination of Product Thickness Applied on Different Areas of the Face Using a Multispectral Imaging Method
An observational study of Sunscreen, run by Pierre Fabre Dermo Cosmetique at 1 site in France.
Trial summary
The aim of the study is to determine: the thickness of the RV4369A truly applied on different areas of the face after single application of the product determined by a multispectral imaging method. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Sunscreen
- What is being tested?
- RV4369A cosmetic product
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2022to 29 Apr 2022
- 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 20 to 55 years
- All sexes
- Adult
Study population: Panel of healthy volonteers
Who may be able to join
- Dry, normal to combination skin
- Phototype I to V inclusive.
- Absence of significant facial hair.
Who cannot join
- Population
- Pregnant, breastfeeding women.
- For men: moustached or bearded.
- Substantial hair on the forearm and face.
- Application of keratolytic or self-tanning products to the face, forearms and arms in the four weeks prior to inclusion.
- With scars or other cutaneous characteristics, sunburn on forearms in the test areas, the size of which is considered incompatible with the study.
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- Application of water, cleansing or beauty products to the forearms and arms since the last wash on the evening before inclusion.
- Diseases :
- Known history of allergy to any of the investigational product ingredients.
- Known history of allergy to latex.
- Skin lesions or skin disease on the face or on the arms and forearms that may affect test results (seborrheic dermatitis, atopic dermatitis, psoriasis, acne, rosacea, etc.).
- Treatments:
- Ongoing local or Oral treatment (retinoids, anti-inflammatory) that may affect test results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Thickness Truly Applied of the SPRAY50+ on Different Areas of the Face Estimated by a Multispectral Imaging Method, After Application of the Product With and Without Recommendations of Use by a Group of Healthy Subjects
The aim of the study is to determine:
- the thickness of the RV4369A truly applied on different areas of the face after single application of the product determined by a multispectral imaging method.
- the influence of a second application of the product 15 to 30 minutes after the first application on the product thickness determined by multispectral imaging method.
- the influence of the recommendations of use provided to the subjects before application of the product on the product thickness determined by multispectral imaging method .
Read the detailed description
This study is a monocentric, comparative, open study performed on the face and forearms of healthy adults.
Planning of the visits:
Visit 1: Inclusion visit (D1) Visit 2: End of study visit (D10), a window of +/- 2 days is allowed for this evaluation, * The theoretical study duration for each subject is 10 days. The maximal study duration for each subject is 12 days.
- Conditions
- Sunscreen
- Being tested
- RV4369A cosmetic product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RV4369A cosmetic productOther
The product is applied 1 or 2 times during the 2 study visits. The product is recovered by the technician after application of the product by the volunteer.
Application modalities:
Inclusion Assessment: The study product is given to the volunteer who applies it to his face (forehead) according to his usual habits.
After a waiting time and Multispectral camera measurements, the study product is again applied by the volunteer to his face according to his usual habits.
Final assessment: The study product is applied by the Clinical Research Technician on the subject's forearm on 4 delimited areas at specific quantities.
After a waiting period and Multispectral camera measurements on the forearm areas, the study product is given to the volunteer who applies it on his face according to the recommendations of use provided by the Technician.
| Study group | Role | What they receive |
|---|---|---|
| Treated Group | all subjects will apply the study product RV4369A Receives: Other: RV4369A cosmetic product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amounts of sun spray applied to the face, measured by multispectral imaging after single application by the subject
The product quantity applied by the subject (mg/cm2) will be extrapolated from a reference curve build using an image analysis technique
Measured: Visit 1 (Day 1)
Amounts of sun spray applied to the face, measured by multispectral imaging after 2 applications by the subject
The product quantity applied by the subject (mg/cm2) will be extrapolated from a reference curve build using an image analysis technique
Measured: Visit 1 (Day 1)
Amounts of sun spray applied to the face, measured by multispectral imaging after 1 application by the subject and according to the recommendations of use provided by the technician
The product quantity applied by the subject (mg/cm2) will be extrapolated from a reference curve build using an image analysis technique
Measured: Visit 2 (Day 10)
Comparisons between measurements of sun spray amounts determined by multispectral imaging
Comparaisons between an application without recommendations of use (Visit 1), an application without recommendations followed by a second application (Visit 1) and an application according to the recommendations of use (Visit 2)
Measured: Visit 1 (Day1) and visit 2 (Day 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start4 Apr 2022
- Primary completion29 Apr 2022
- Study completion29 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SunscreenStudies 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thérèse Nocera, MD, Principal investigator, Pierre Fabre Dermo Cosmetique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837208
- Sponsor's protocol ID
- ADPROTECTPF
- Status last verified
- Apr 2023
- First submitted
- 19 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Thickness Truly Applied of the SPRAY50+ on Different Areas of the Face Estimated by a Multispectral Imaging Method, After Application of the Product With and Without Recommendations of Use by a Group of Healthy Subjects
- ClinicalTrials.gov ID
- NCT05837208
- Acronym / sponsor ID
- ADPROTECTPF
- Conditions
- Sunscreen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 1 May 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 aim of the study is to determine:
- the thickness of the RV4369A truly applied on different areas of the face after single application of the product determined by a multispectral imaging method.
- the influence of a second application of the product 15 to 30 minutes after the first application on the product thickness determined by multispectral imaging method.
- the influence of the recommendations of use provided to the subjects before application of the product on the product thickness determined by multispectral imaging method .
Detailed description
This study is a monocentric, comparative, open study performed on the face and forearms of healthy adults.
Planning of the visits:
Visit 1: Inclusion visit (D1) Visit 2: End of study visit (D10), a window of +/- 2 days is allowed for this evaluation, * The theoretical study duration for each subject is 10 days. The maximal study duration for each subject is 12 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated Group | – | Other: RV4369A cosmetic productall subjects will apply the study product RV4369A |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Age groups
- Adult
- Study population
- Panel of healthy volonteers
Key inclusion criteria (3 listed)
- Dry, normal to combination skin
- Phototype I to V inclusive.
- Absence of significant facial hair.
Key exclusion criteria (13 listed)
- Population
- Pregnant, breastfeeding women.
- For men: moustached or bearded.
- Substantial hair on the forearm and face.
- Application of keratolytic or self-tanning products to the face, forearms and arms in the four weeks prior to inclusion.
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 |
|---|---|---|
| RV4369A cosmetic productThe product is applied 1 or 2 times during the 2 study visits. The product is recovered by the technician after application of the product by the volunteer. Application modalities: Inclusion Assessment: The study product is given to the volunteer who applies it to his face (forehead) according to his usual habits. After a waiting time and Multispectral camera measurements, the study product is again applied by the volunteer to his face according to his usual habits. Final assessment: The study product is applied by the Clinical Research Technician on the subject's forearm on 4 delimited areas at specific quantities. After a waiting period and Multispectral camera measurements on the forearm areas, the study product is given to the volunteer who applies it on his face according to the recommendations of use provided by the Technician. | Other | Treated Group |
Primary outcome
Amounts of sun spray applied to the face, measured by multispectral imaging after single application by the subject
Time frame: Visit 1 (Day 1)
The product quantity applied by the subject (mg/cm2) will be extrapolated from a reference curve build using an image analysis technique
Amounts of sun spray applied to the face, measured by multispectral imaging after 2 applications by the subject
Time frame: Visit 1 (Day 1)
The product quantity applied by the subject (mg/cm2) will be extrapolated from a reference curve build using an image analysis technique
Amounts of sun spray applied to the face, measured by multispectral imaging after 1 application by the subject and according to the recommendations of use provided by the technician
Time frame: Visit 2 (Day 10)
The product quantity applied by the subject (mg/cm2) will be extrapolated from a reference curve build using an image analysis technique
Comparisons between measurements of sun spray amounts determined by multispectral imaging
Time frame: Visit 1 (Day1) and visit 2 (Day 10)
Comparaisons between an application without recommendations of use (Visit 1), an application without recommendations followed by a second application (Visit 1) and an application according to the recommendations of use (Visit 2)
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 May 2023.
Related trials for Sunscreen
Active, not recruiting
Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions
Melanoma (Skin Cancer)
RecruitingPhase 4
A Clinical Study to Evaluate the Efficacy and SPF of Two Test Materials According to an Adaptation of the Guidelines of the FDA Sunscreen Drug Products for Over-the-Counter Human Use
Epidermis, Ultraviolet Exposure
Recruiting
A Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Participants
Post-inflammatory Hyperpigmentation, Melasma
Enrolling by invitationObservational study
Expert Consensus on Photoprotection Practices: A Delphi Study
Photoprotection, Sunscreen
Enrolling by invitation
Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics
Sunburn, Sun Damaged Skin
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.
Thérèse Nocera, MD principal investigator
Pierre Fabre Dermo Cosmetique
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 Sunscreen, 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 3 inclusion and 13 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 May 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?
Amounts of sun spray applied to the face, measured by multispectral imaging after single application by the subject (time frame: Visit 1 (Day 1)). The study lists 4 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 May 2023.