An observational study in Acne, sponsored by Pierre Fabre Dermo Cosmetique. Completed at 1 site in Portugal. Open to participants aged 12 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-23.
Sponsored by Pierre Fabre Dermo Cosmetique · Observational
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.
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 :
The study includes 4 visits :
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.
Pierre Fabre Dermo Cosmetique is the lead sponsor of 58 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Related to the population:
Related to the disease:
Exclusion Criteria:
Related to the population:
Related to the disease
Related to treatments
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.
Other: RV4857A
RV4857A formula CD2110 is a sunscreen product
Assessment of the dermatological physical signs
The assessment of the dermatological physical signs is based on a visual examination
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from Baseline to 29 days later
Change of the number of total acne lesions on the face
by counting according to the method of Lucky
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
by counting according to the method of Lucky
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
by counting according to the method of Lucky
Time frame: 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
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
* 0: Clear * 1: Almost clear * 2: Mild * 3: Moderate * 4: Severe * 5 : Very Severe
Time frame: 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, 1. Mild improvement, 2. Moderate improvement, 3. Good improvement, 4. Very good improvement
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
Questions Q24 and Q25 at D85 in the self-questionnaire
Time frame: 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)
Time frame: 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
Time frame: Change from Baseline to 29 and 57 days later
Plan to share: No
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This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Pierre Fabre Dermo Cosmetique