UVA Protection Factors of SPF 50 and 50+ Face Sunscreens

NCT06068010 | Completed

• 1 other identifier: LRP20005-face sunscreens
• Study Type: observational
• Target: 412
• Locations: 4 countries
• Sites: 6

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.

Conditions

Ultraviolet-Induced Change in Normal Skin

Keywords

sunscreen; UVA protection; ISO 24442:2011; photoprotection

Outcome Measures

Primary Outcomes (1)

• Evaluate the protection factor of the investigational product against UVA

  The UVAPF test method uses persistent pigment darkening (PPD) responses of the skin as the end point for evaluating transmitted UVA radiation. The test is restricted to the area of the back of selected human subjects. 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. To determine the UVAPF, incremental series of UVA exposures are delivered to five or six small sub-sites on the skin to induce darkening responses. These responses are visually assessed for pigment darkness 2 h to 24 h after UVA exposure, by the judgement of a trained evaluator.

  from baseline to 24 hours

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adults meeting the inclusion and exclusion criteria and willing to adhere to the protocol and study procedures

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cosmetique Active International: lead

Study Sites (6)

Allergisa

Campinas, Brazil

Location

EVIC

Bordeaux, France

Location

Intertek

Paris, France

Location

Eurofins Dermscan France

Villeurbanne, France

Location

Eurofins Dermscan Poland

Gdansk, Poland

Location

CIDP

Bucharest, Romania

Location

Study Officials

• Caroline Le Floc'h

  Cosmetique Active International

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 5, 2023
• Study Start: April 20, 2018
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: October 6, 2023

Record last verified: 2023-10

Locations

RO (1); PL (1); BR (1); FR (3)