AcneNCT05168397
Sunscreen Efficacy Against the Reccurence of Lesions Post-sun Exposure in Acneic Subjects
An observational study of Acne, run by Pierre Fabre Dermo Cosmetique at 1 site in Portugal.
Trial summary
The aim of this study is firstly to assess the tolerance of the sunscreen RV4857A-CD2110 after 28 days and 57 days of at least a twice daily on the study areas, secondly to assess anti-imperfection efficacy after 28 days and 57 days of use and its efficacy against recurrence of acne lesions post-sun exposure. Read more about this study
- Who is it for?
- Ages 12 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- RV4857A
- How many people
- 45 participants
- Where
- 1 sitePortugal
- Study dates
- 16 Jul 2020to 9 Nov 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 12 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, 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
- Related to the population:
- Females and/or males (with at least 25% of male)
- Age: adults from 18 to 40 years old and adolescent from 12 to 17 years old (33% to 50% of the total population)
- Considered "healthy subject" by the Investigator
- Being of Phototype I to IV
- Subject with combination to oily skin
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- Subject who foresees sun exposure during the first 2 months of the study
- Subjects must be registered with health social security or health social insurance (if required by national regulations)
- Subject and/or parent(s)/legal representative(s) who have signed his/her/their written informed consent for his/her participation in the study (or his/her/their child participation in the study) and a photograph authorization
- For woman of childbearing potential: committing herself to use effective contraceptive method since at least 3 months before the beginning of the study and committing to it throughout the study
- Regular users of very high protection sunscreen products.
- Related to the disease:
- For adults and adolescents: subject with mild to moderate acne with a total of 10 to 40 acne lesions (at least 5 non-inflammatory lesions (open and closed comedones) and at least 3 to 10 inflammatory lesions (papules and pustules) maximum on the face, excluding the nose area), at the inclusion.
- Subject prone to have recurrence of acne lesions in autumn (declarative)
Who cannot join
- Related to the population:
- Having participated in another clinical trial within 4 weeks before the inclusion visit and for a longer period if required in the Investigator's opinion Taking part or planning to participate in another clinical trial during the study in the same or another investigation centre
- Breastfeeding or pregnant or not willing to take necessary precautions to avoid pregnancy during the study and for at least 3 months before the inclusion visit (for the woman of childbearing potential)
- Subject or parent(s)/legal representative(s) deprived of freedom by administrative or legal decision or under guardianship
- Subject or parent(s)/legal representative(s) not able to be contacted in case of emergency
- Subject admitted in a sanitary or social facility
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- Subject planning a hospitalization during the study
- Related to the disease
- Cutaneous pathology (psoriasis, atopic dermatitis, skin infectious disease of viral, bacterial, fungus or parasitic origin …) or dermatological condition (especially pityriasis versicolor, severe pigmentation disorders) on the studied zone other than acne liable to interfere with the data of the study
- Severe acne
- Clinical signs of hormonal disfunctions or hyperandrogenism
- Excessive exposure to sunlight or UV-rays within the previous month
- Having history of abnormal reactions from exposure to sunlight
- Use of self tanning product during the previous month History of hypersensitivity or intolerance to any cosmetic product
- Related to treatments
- Use of a systemic or topical medication with anti-inflammatory or photosensitising products during the previous 2 weeks and for systemic medication with corticoids and/or antihistaminics during the previous 4 weeks
- Use of a systemic treatment for acne during the previous month for antibiotics, zinc gluconate and hormonal treatment and during the 6 previous months for isotretinoin
- Use of a topical treatment for acne during the previous month (benzoil peroxide, retinoid, antibiotics, azelaic acid…)
- Use of anti-acneic or anti-seborrheic cosmestic care (containing alpha hydroxy-acids, retinoic derivatives..) during the 15 previous days
- Use of other topical or systemic treatment during the previous weeks liable to interfere with the assessment of the cutaneous tolerance and efficacy of the studied product (according to the investigator's appreciation)
- Any surgery, chemical or physical treatment on the experimental area within the 12 months prior to the study or foreseeing it for the duration of the study
- Woman whose oral contraception is instaured or changed for less than 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Cutaneous and Ocular Tolerance of RV4857A Sunscreen Product and Its Efficacy Against the Recurrence of Lesions Post Sun Exposure in Subjects With Facial Acne
The aim of this study is firstly to assess the tolerance of the sunscreen RV4857A-CD2110 after 28 days and 57 days of at least a twice daily on the study areas, secondly to assess anti-imperfection efficacy after 28 days and 57 days of use and its efficacy against recurrence of acne lesions post-sun exposure.
Read the detailed description
This is a monocentric study on adults and adolescents with acne prone skin on the face. This open-labelled study aim first to assess the dermatological and ophthalmological tolerance of the investigational sunscreen product RV4857A formula CD2110 after 28 days and, dermatological tolerance after 57 days of at least a twice daily on the study areas, under normal conditions of use, on 40 subjects intending to have a minimum of 10 days per month of sun exposure duration ≥ 1h, in the time slot 11am-4pm and intending to have a minimum of 4 swimming sessions (sea or swimming pool) during at least the first month of the study.
Secondary objectives :
- To assess the anti-imperfection efficacy of the product during the summer
- To assess the "non" rebound effect (non recurrence of acne) one month after stopping the application of the sunscreen and without any sun exposure at D85 (difference between D85 and D0)
- To evaluate the impact on Quality of Life of subjects through CADI and DLQI questionnaires (or CDLQI questionnaire for adolescent from 12 to 16 years-old) completed at baseline, D29 and D57
The study includes 4 visits :
- Visit 1: Inclusion visit (D1)
- Visit 2: Intermediate visit (D29)
- Visit 3: Intermediate visit "end of summer" (D57), a Stop the application of the sunscreen product (and stop sun exposure) between Visit 3 and the end of the study Visit 4: End of study visit in autumn (D85)
The theoretical study duration for each subject will be 85 days with at least 57 days of product use. The study interest areas are Face and Neck.
- Conditions
- Acne
- Being tested
- RV4857A
- Keywords
- Sunscreen, Lesions post sun exposure, Anti-imperfections
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RV4857AOther
RV4857A formula CD2110 is a sunscreen product
| Study group | Role | What they receive |
|---|---|---|
| RV4857A arm | Application of the product before and during each sun exposure, at least twice a day.
During sun exposures, the applications were renewed as often as necessary, in particular after swimming, perspiring, towelling, in order to ensure a good protection. On days of bad weather, the product was applied in the morning and at the beginning of the afternoon. Receives: Other: RV4857A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the dermatological physical signs
The assessment of the dermatological physical signs is based on a visual examination
Measured: Change from Baseline to 30 minutes after product application, to 29 and 57 days later
Assessment of the dermatological functional signs
The functional signs is assessed by questioning the subject
Measured: Change from Baseline to 30 minutes after product application, to 29 and 57 days later
Assessment of the ophthalmological physical signs
The assessment of the ophthalmological physical signs is based on a dermatologist visual examination
Measured: Change from Baseline to 30 minutes after product application, to 29 and 57 days later
Assessment of the ophthalmological functional signs
The functional signs is assessed by questioning the subject
Measured: Change from Baseline to 30 minutes after product application, to 29 and 57 days later
Assessment of the Tear film Break Up Time (BUT)
The tear film break-up time is a test to measure the relative stability of the pre-corneal tear film. This examination is performed by the same Ophthalmologist thanks to a biomicroscope after blinking (using a chronometer). The measured time will be expressed in seconds
Measured: Change from Baseline to 30 minutes after product application, to 29 and 57 days later
Assessment of global tolerance assessment (dermatogical assesment), a 5-point scale
- Excellent: no functional nor physical signs related to the investigational product observed or reported by the subjects
- Very good
- Good
- Moderate
- Bad
Measured: Change from Baseline to 29 and 57 days later
Assessment of global tolerance assessment (ophthalmological assessment), a 5-point scale
- Excellent: no functional nor physical signs related to the investigational product observed or reported by the subjects
- Very good
- Good
- Moderate
- Bad
Measured: Change from Baseline to 29 days later
Secondary outcomes (9)
Change of the number of total acne lesions on the face
by counting according to the method of Lucky
Measured: Change from Baseline to 29, 57 and 85 days later
Change of the number of non-inflammatory lesions (open and closed comedones) on the face
by counting according to the method of Lucky
Measured: Change from Baseline to 29, 57 and 85 days later
Change of the number of inflammatory lesions (papules, pustules, nodules) on the face
by counting according to the method of Lucky
Measured: Change from Baseline to 29, 57 and 85 days later
Assessment of the non-comedogenic potential
by statistical comparison of open and closed comedones counted by the investigator on the face before and after 28 days of application of investigational product
Measured: Change from Baseline to 29 days later
Change of the acne severity, assess by Global Acne Evaluation (GEA) on a 6-point scale
- 0: Clear
- 1: Almost clear
- 2: Mild
- 3: Moderate
- 4: Severe
- 5 : Very Severe
Measured: Change from Baseline to 29, 57 and 85 days later
Evaluation of the global acne evolution on a 6-point scale
-1: Worsening, 0: No change,
- Mild improvement,
- Moderate improvement,
- Good improvement,
- Very good improvement
Measured: Change from Baseline to 29 and 57 days later
Evaluation of the global product efficacy by the subjects themselves regarding rebound effect in Autumn
Questions Q24 and Q25 at D85 in the self-questionnaire
Measured: Change from Baseline to 85 days later
Assessment of the cosmetic acceptability and perceived efficacy of the product
The self subject assemsment consists of different questions concerning participants' perception of the product's efficacy (majority of scales ranging from 0 to 10 where 0 was the worst satisfaction and 10 the best one)
Measured: Change from Baseline to 29 and 57 days later
To evaluate the impact on Quality of Life of subjects through questionnaires
Quality of Life questionnaires consist of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week
Measured: Change from Baseline to 29 and 57 days later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start16 Jul 2020
- Primary completion9 Nov 2020
- Study completion9 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pedro Contreiras Pinto, PhD, Study chair, PhD Trials®Leonor Girão, MD, Principal investigator, PhD Trials®
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168397
- Sponsor's protocol ID
- RV4857A202092
- Status last verified
- Dec 2021
- First submitted
- 29 Sep 2021
- Last updated
- 23 Dec 2021
- 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 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Cutaneous and Ocular Tolerance of RV4857A Sunscreen Product and Its Efficacy Against the Recurrence of Lesions Post Sun Exposure in Subjects With Facial Acne
- ClinicalTrials.gov ID
- NCT05168397
- Acronym / sponsor ID
- RV4857A202092
- Conditions
- Acne
- Keywords
- Sunscreen, Lesions post sun exposure, Anti-imperfections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 9 Nov 2020 (actual)
- Study completion
- 9 Nov 2020 (actual)
- First posted
- 23 Dec 2021 (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 this study is firstly to assess the tolerance of the sunscreen RV4857A-CD2110 after 28 days and 57 days of at least a twice daily on the study areas, secondly to assess anti-imperfection efficacy after 28 days and 57 days of use and its efficacy against recurrence of acne lesions post-sun exposure.
Detailed description
This is a monocentric study on adults and adolescents with acne prone skin on the face. This open-labelled study aim first to assess the dermatological and ophthalmological tolerance of the investigational sunscreen product RV4857A formula CD2110 after 28 days and, dermatological tolerance after 57 days of at least a twice daily on the study areas, under normal conditions of use, on 40 subjects intending to have a minimum of 10 days per month of sun exposure duration ≥ 1h, in the time slot 11am-4pm and intending to have a minimum of 4 swimming sessions (sea or swimming pool) during at least the first month of the study.
Secondary objectives :
- To assess the anti-imperfection efficacy of the product during the summer
- To assess the "non" rebound effect (non recurrence of acne) one month after stopping the application of the sunscreen and without any sun exposure at D85 (difference between D85 and D0)
- To evaluate the impact on Quality of Life of subjects through CADI and DLQI questionnaires (or CDLQI questionnaire for adolescent from 12 to 16 years-old) completed at baseline, D29 and D57
The study includes 4 visits :
- Visit 1: Inclusion visit (D1)
- Visit 2: Intermediate visit (D29)
- Visit 3: Intermediate visit "end of summer" (D57), a Stop the application of the sunscreen product (and stop sun exposure) between Visit 3 and the end of the study Visit 4: End of study visit in autumn (D85)
The theoretical study duration for each subject will be 85 days with at least 57 days of product use. The study interest areas are Face and Neck.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RV4857A arm | – | Other: RV4857AApplication of the product before and during each sun exposure, at least twice a day. During sun exposures, the applications were renewed as often as necessary, in particular after swimming, perspiring, towelling, in order to ensure a good protection. On days of bad weather, the product was applied in the morning and at the beginning of the afternoon. |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, 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 (14 listed)
- Related to the population:
- Related to the disease:
Key exclusion criteria (22 listed)
- Related to the population:
- Related to the disease
- Related to treatments
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 |
|---|---|---|
| RV4857ARV4857A formula CD2110 is a sunscreen product | Other | RV4857A arm |
Primary outcome
Assessment of the dermatological physical signs
Time frame: Change from Baseline to 30 minutes after product application, to 29 and 57 days later
The assessment of the dermatological physical signs is based on a visual examination
Assessment of the dermatological functional signs
Time frame: Change from Baseline to 30 minutes after product application, to 29 and 57 days later
The functional signs is assessed by questioning the subject
Assessment of the ophthalmological physical signs
Time frame: Change from Baseline to 30 minutes after product application, to 29 and 57 days later
The assessment of the ophthalmological physical signs is based on a dermatologist visual examination
Assessment of the ophthalmological functional signs
Time frame: Change from Baseline to 30 minutes after product application, to 29 and 57 days later
The functional signs is assessed by questioning the subject
Assessment of the Tear film Break Up Time (BUT)
Time frame: Change from Baseline to 30 minutes after product application, to 29 and 57 days later
The tear film break-up time is a test to measure the relative stability of the pre-corneal tear film. This examination is performed by the same Ophthalmologist thanks to a biomicroscope after blinking (using a chronometer). The measured time will be expressed in seconds
Assessment of global tolerance assessment (dermatogical assesment), a 5-point scale
Time frame: Change from Baseline to 29 and 57 days later
* Excellent: no functional nor physical signs related to the investigational product observed or reported by the subjects * Very good * Good * Moderate * Bad
Assessment of global tolerance assessment (ophthalmological assessment), a 5-point scale
Time frame: Change from Baseline to 29 days later
* Excellent: no functional nor physical signs related to the investigational product observed or reported by the subjects * Very good * Good * Moderate * Bad
9 secondary outcomes
Change of the number of total acne lesions on the face
Time frame: Change from Baseline to 29, 57 and 85 days later
Change of the number of non-inflammatory lesions (open and closed comedones) on the face
Time frame: Change from Baseline to 29, 57 and 85 days later
Change of the number of inflammatory lesions (papules, pustules, nodules) on the face
Time frame: Change from Baseline to 29, 57 and 85 days later
Assessment of the non-comedogenic potential
Time frame: Change from Baseline to 29 days later
Change of the acne severity, assess by Global Acne Evaluation (GEA) on a 6-point scale
Time frame: Change from Baseline to 29, 57 and 85 days later
Evaluation of the global acne evolution on a 6-point scale
Time frame: Change from Baseline to 29 and 57 days later
Evaluation of the global product efficacy by the subjects themselves regarding rebound effect in Autumn
Time frame: Change from Baseline to 85 days later
Assessment of the cosmetic acceptability and perceived efficacy of the product
Time frame: Change from Baseline to 29 and 57 days later
To evaluate the impact on Quality of Life of subjects through questionnaires
Time frame: Change from Baseline to 29 and 57 days later
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 23 Dec 2021.
- 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.
Pedro Contreiras Pinto, PhD study chair
PhD Trials®
Leonor Girão, MD principal investigator
PhD Trials®
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 Acne, run by Pierre Fabre Dermo Cosmetique at 1 site in Portugal.
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 14 inclusion and 22 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 23 Dec 2021. 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 Portugal. 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?
Assessment of the dermatological physical signs (time frame: Change from Baseline to 30 minutes after product application, to 29 and 57 days later). The study lists 7 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 23 Dec 2021.