Sunscreen Efficacy Against the Reccurence of Lesions Post-sun Exposure in Acneic Subjects

NCT05168397 | Completed

• 1 other identifier: RV4857A202092
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acne

Keywords

Sunscreen; Lesions post sun exposure; Anti-imperfections

Outcome Measures

Primary Outcomes (7)

• Assessment of the dermatological physical signs

  The assessment of the dermatological physical signs is based on a visual examination

  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

  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

  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

  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

  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

  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

  Change from Baseline to 29 days later

Secondary Outcomes (9)

• Change of the number of total acne lesions on the face

  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

  Change from Baseline to 29, 57 and 85 days later

• Change of the number of inflammatory lesions (papules, pustules, nodules) on the face

  Change from Baseline to 29, 57 and 85 days later

• Assessment of the non-comedogenic potential

  Change from Baseline to 29 days later

• Change of the acne severity, assess by Global Acne Evaluation (GEA) on a 6-point scale

  Change from Baseline to 29, 57 and 85 days later

Study Arms (1)

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.

Other: RV4857A

Interventions

RV4857A OTHER

RV4857A formula CD2110 is a sunscreen product

RV4857A arm

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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
• 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:
• Subject prone to have recurrence of acne lesions in autumn (declarative)

You may not qualify if:

• Related to the population:
• 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
• 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

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

PhD Trials®

Lisbon, 1750-182, Portugal

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Pedro Contreiras Pinto, PhD

  PhD Trials®

  STUDY CHAIR

• Leonor Girão, MD

  PhD Trials®

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: December 23, 2021
• Study Start: July 16, 2020
• Primary Completion: November 9, 2020
• Study Completion: November 9, 2020
• Last Updated: December 23, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)