Agents Effect Under Visible Light on Caucasian, Asian and Darker Skin Types

NCT07462845 | Completed

• 1 other identifier: ACR_VLAD_22-08057
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The study intends to get knowledge on pigmentation induced by visible light on Asian/Chinese skin type and darker skin type, and to evaluate and to compare with a non-treated control zone and between them, the efficacy of photoprotective effect of different products after visible light exposure, between \[400-700nm\], on these skin types compared to Caucasian for whom the investigators already got knowledge.

Conditions

Visible Light Exposure on Healthy Back Skin

Keywords

pigmentation; visible light

Outcome Measures

Primary Outcomes (2)

• Skin color measurement with ITA° angle

  The device Chromameter® (non-invasive assessment) will be used to measure the skin color, between the exposed zone (ZE) and non-exposed zone (ZNE), through the ITA° angle calculation, using formula \[Arc Tangent ((L\* - 50) / b\*)\] 180 / p. The L\* defines the perceptual lightness from black at 0 to white at 100. The b\* represents the blue-yellow opponents, with negative numbers toward blue and positive toward yellow.

  From enrollment at Day 1 to the end of study at Day 12

• Skin pigmentation contrast

  The device Chromameter® (non-invasive assessment) will be used to measure the skin contrast, between the exposed zone (ZE) and non-exposed zone (ZNE), through the Delta E calculation, using formula √ (ΔL\*2+Δa\*2+Δb\*2)). The L\* defines the perceptual lightness from black at 0 to white at 100. The a\* axis is relative to the green-red opponent colors, with negative values toward green and positive values toward red. The b\* represents the blue-yellow opponents, with negative numbers toward blue and positive toward yellow.

  From enrollment at Day 1 to the end of study at Day 12

Secondary Outcomes (2)

• Visual scoring of pigmentation

  From enrollment at Day 1 to the end of study at Day 12

• Visual scoring of erythema

  From enrollment at Day 1 to the end of study at Day 12

Study Arms (3)

Caucasian

22 volunteers Caucasian skin with a skin phototype III or IV

Asian

22 volunteers Asian skin with a skin phototype III-IV

Darker skin

22 volunteers darker skin with a skin phototype VI

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy male and female volunteers from 18 to 50 yo, with Fitzpatrick III to VI and an ITA° between -30° to +36° at screening.

You may qualify if:

• To be enrolled in this study, all subjects must satisfy all the following criteria at study entry:
• Healthy female or male volunteer from 18 to 50 years old
• Caucasian Skin type III-IV according to the Fitzpatrick classification OR Asian Skin type III-IV (chinese population) according to the Fitzpatrick classification OR Darker Skin type VI according to the Fitzpatrick classification
• Uniform skin color over the four zones (difference in ITA° between each zone should not be more than 4°)
• Absence of freckles, naevi, hypo or hyper pigmented regions, hairs and marks of bronzing on the investigational area on the back
• Female subject of childbearing potential, who is not sexually active, or using an effective contraceptive method\* for at least one month before the beginning of the study, and throughout the study or menopausal female (with absence of menstruations for less than one year) or post-menopausal female (with absence of menstruations for more than one year)
• \*Effective contraceptive methods: sexually active female of childbearing potential should either be surgically sterile (oophorectomy, hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intravaginal device, intrauterine device (IUD), condom with spermicide
• Female of childbearing potential or menopausal female (with absence of menstruations for less than one year) willing to undergo urine pregnancy test
• Subject willing and able to fulfil the study requirements and schedule
• Subject informed about the study objectives and procedures, and able to understand them
• Subject who has given written informed consent

You may not qualify if:

• Subject who is pregnant or lactating or who is planning to become pregnant during the study
• Subject with BMI \> 30 except if, according to the investigator's judgement, the subject is able to follow the study procedure without compromising his/her health
• Having planned UV exposure of the investigational area (sunlight or sunbeds) throughout the study
• Having sunburn (erythema) on the back
• Dermatological disorders affecting the investigational area (presence of naevi, freckles, excess hair or uneven skin tones, vitiligo, photo-dermatological problems)
• History of skin cancer
• History of abnormal response to sun
• Presence of recent suntan (according to Investigator opinion) or photo-test marks
• History of allergy, hypersensitivity, or any serious reaction to any cosmetic product
• Any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator
• Having used, within the past 6 months, any physical treatment including laser or phototherapy (PUVA, IPL, PDT…) on the investigational area, or having planned to use these treatments during the study
• Having planned to perform intensive sport (\> 5 hours per week) or to swim or to practice hammam/sauna during the study
• Subject who declares to be deprived of freedom by administrative or legal decision
• Subject who cannot be contacted by telephone in case of emergency

Sponsors & Collaborators

• L'Oreal: lead

Study Sites (1)

L'Oréal

Aulnay-sous-Bois, 93600, France

Location

Study Design

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

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 10, 2026
• Study Start: September 5, 2022
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)