Clinical trial NCT06068010: UVA Protection Factors of SPF 50 and 50+ Face Sunscreens
Official title: UVA Protection Factors of SPF 50 and 50+ Face Sunscreens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultraviolet-Induced Change in Normal Skin
Keywords: sunscreen
UVA protection
ISO 24442:2011
photoprotection
Lead sponsor: Cosmetique Active International
Sponsor class: INDUSTRY
First posted: 2023-10-05
Enrollment: 412
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults meeting the inclusion and exclusion criteria and willing to adhere to the protocol and study procedures

Brief summary: The goal of this observational study is to use the International Organization for Standardization (ISO) 24442:2011 in vivo method for assessment of the Ultraviolet A Protection Factor (UVAPF) of topical sunscreen products in healthy adults. The main question it aims to answer is to determine the degree of UVA-protection against UVA radiation.

An area of each subject's skin is exposed to UVA light without any protection and another (different) area is exposed after application of the sunscreen product under test. One further area is exposed after application of a reference UVA sunscreen formulation (S2), which is used to validate the procedure.

Detailed description: The objective of the study conducted in accordance with the Declaration of Helsinki and national regulations regarding human studies is to evaluate the UVA protection factor of the investigational products against UVA, according to the ISO 24442:2011 methodology comparatively to a standard product (Standard S2) in healthy adult subjects.

Standard reference S2 sunscreen formula is used in a study if any test sample has an expected UVAPF of 12 or above. The mean UVAPF for the reference sample S2 is 12,7. The test result of the reference S2 UVAPF must be between 10,7 and 14,7 or the test is invalid and shall be repeated. The reference S2 may be used to validate any product test.

In order to determine the number of subjects, the 95 % confidence interval (CI) shall be taken into account. The 95 % confidence interval should lie within ±17 % of the mean UVAPF, and a minimum of 10 subjects is required.

Eligibility criteria: Inclusion Criteria:

* Fitzpatrick skin phototype: II, III or IV
* colorimetric Individual Typology Angle (ITA°): 20° to 41°
* intact skin on test site

Exclusion Criteria:

* pregnant or lactating women
* subjects using medication with photo-sensitizing potential
* subjects receiving chemotherapy or radiotherapy
* subjects who have had UV exposure on the back area in the four weeks prior to UVAPF testing

Primary outcomes:
measure: Evaluate the protection factor of the investigational product against UVA
timeFrame: from baseline to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Allergisa
city: Bordeaux
country: France
facility: EVIC
city: Paris
country: France
facility: Intertek
city: Villeurbanne
country: France
facility: Eurofins Dermscan France
city: Gdańsk
country: Poland
facility: Eurofins Dermscan Poland
city: Bucharest
country: Romania
facility: CIDP
Study officials:
affiliation: Cosmetique Active International
name: Caroline Le Floc'h
role: STUDY_DIRECTOR
References: