Photoprotection Efficacy of Different Topical Agents Under Visible Light Exposure

NCT06796153 | Completed

• 1 other identifier: ACR_VLSP_21-02775
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the protective effect of seven sunscreens on the pigmentation induced by visible light in comparison to an untreated control zone in healthy volunteers

Conditions

Visible Light Exposure 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 and Day 5 (24 hours after each Visible Light exposure).

Secondary Outcomes (4)

• Clinical investigator's assessment by using clinical scale

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

• 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 and Day 5 (24 hours after each Visible Light exposure).

• Safety / Local Tolerance

  From the informed consent signature date until the end of the study (Day 5)

• 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 and Day 5 (24 hours after each Visible Light exposure)

Study Arms (8)

Product 1

The test product 1 was applied (2 mg/cm²) on the attributed zone according to the randomization list. The application was done during 4 consecutive days (From Day 1 to Day 4).

Other: Visible Light Exposure - Treated zones

Product 2

The test product 2 was applied (2 mg/cm²) on the attributed zone according to the randomization list. The application was done during 4 consecutive days (From Day 1 to Day 4).

Other: Visible Light Exposure - Treated zones

Product 3

The test product 3 was applied (2 mg/cm²) on the attributed zone according to the randomization list. The application was done during 4 consecutive days (From Day 1 to Day 4).

Other: Visible Light Exposure - Treated zones

Product 4

The test product 4 was applied (2 mg/cm²) on the attributed zone according to the randomization list. The application was done during 4 consecutive days (From Day 1 to Day 4).

Other: Visible Light Exposure - Treated zones

Product 5

The test product 5 was applied (2 mg/cm²) on the attributed zone according to the randomization list. The application was done during 4 consecutive days (From Day 1 to Day 4).

Other: Visible Light Exposure - Treated zones

Product 6

The test product 6 was applied (2 mg/cm²) on the attributed zone according to the randomization list. The application was done during 4 consecutive days (From Day 1 to Day 4).

Other: Visible Light Exposure - Treated zones

Product 7

The test product 7 was applied (2 mg/cm²) on the attributed zone according to the randomization list. The application was done during 4 consecutive days (From Day 1 to Day 4).

Other: Visible Light Exposure - Treated zones

Untreated zone

non-treated control zone

Other: Visible Light Exposure - Untreated zone

Interventions

Visible Light Exposure - Treated zones OTHER

The treated zones were exposed to Visible Light to induce skin pigmentation (144J/cm2), 15 to 30 minutes after application.

Product 1; Product 2; Product 3; Product 4; Product 5; Product 6; Product 7

Visible Light Exposure - Untreated zone OTHER

The untreated zone was exposed to Visible Light to induce skin pigmentation (144J/cm2), as the same time as the treated zones.

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 eight 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
• Having 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: April 23, 2021
• Primary Completion: June 18, 2021
• Study Completion: June 18, 2021
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)