Photoprotection Efficacy of a Sunscreen Under Visible Light Exposure by Using Two Different Simulators

NCT06796140 | Completed

• 1 other identifier: ACR_VALVI2_21-00740
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the ability of a protected agent to prevent the pigmentation under visible light exposures (VL) using two different simulators in healthy volunteers

Conditions

Visible Light Exposures on Healthy Back Skin

Keywords

Photoprotection; Sunscreen; Visible Light (VL); Pigmentation

Outcome Measures

Primary Outcomes (1)

• Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE)

  Pigmentation (Delta E - calculated values)

  At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4, Day 5 (24 hours after each Visible Light exposure) and at Day 12.

Secondary Outcomes (4)

• Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE)

  At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4, Day 5 (24 hours after each Visible Light exposure) and at Day 12.

• Clinical investigator's assessment by using clinical scale

  At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4, Day 5 (24 hours after each Visible Light exposure) and at Day 12.

• Safety and Local Tolerance

  From the informed consent signature date until the end of the study Day 12

• Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE)

  At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4, Day 5 (24 hours after each Visible Light exposure) and Day 12.

Study Arms (2)

Product 1

The tested product 1 was applied on 2 zones (one zone on each hemi-back), by gentle massage, according to the randomization list, 15 to 30-minutes before the Visible Light exposure. The application was done during 4 consecutive days (From Day 1 to Day 4).

Other: Visible Light Exposure - Treated zone - Left hemi-back; Other: Visible Light Exposure - Treated zone - Right hemi-back

Untreated zone

2 non-treated control zones (one zone on each hemi-back)

Other: Visible Light Exposure - Untreated zone - Left hemi-back; Other: Visible Light Exposure - Untreated zone - Right hemi-back

Interventions

Visible Light Exposure - Treated zone - Left hemi-back OTHER

The treated zone located on the left side of the hemi-back was exposed to Visible Light with the simulator 1 to induce skin pigmentation (144J/cm2), 15 to 30 minutes after application.

Product 1

Visible Light Exposure - Treated zone - Right hemi-back OTHER

The treated zone located on the right side of the hemi-back was exposed to Visible Light with the simulator 2 to induce skin pigmentation (144J/cm2), 15 to 30 minutes after application.

Product 1

Visible Light Exposure - Untreated zone - Left hemi-back OTHER

The untreated zone located on the left side of the hemi-back was exposed to Visible Light with the simulator 1 to induce skin pigmentation (144J/cm2), as the same time as the treated zone.

Untreated zone

Visible Light Exposure - Untreated zone - Right hemi-back OTHER

The untreated zone located on the right side of the hemi-back was exposed to Visible Light with the simulator 2 to induce skin pigmentation (144J/cm2), as the same time as the treated zone.

Untreated zone

Eligibility Criteria

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

Study Population

Healthy male and female volunteers from 18 to 50 years old with phototype III to IV according to the Fitzpatrick scale and with an ITA° between 18° to 32° at Screening

You may qualify if:

• Healthy female or male volunteer from 18 to 50 years old
• Skin type III-IV 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
• 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 swim 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

• Cosmetique Active International: lead

Study Sites (1)

CIDP Biotechnology S.R.L

Bucharest, 011607, Romania

Location

Study Design

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

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 28, 2025
• Study Start: March 8, 2021
• Primary Completion: April 9, 2021
• Study Completion: April 9, 2021
• Last Updated: January 30, 2025

Record last verified: 2025-01

Locations

RO (1)