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

NCT ID: NCT06796140

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-08
• Study Completion Date: 2021-04-09

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

Detailed Description

The sunscreens usually used as photoprotectors are known to protect in the UV domain (UVB and UVA). However, until recently visible light (400-700 nm) was considered as devoid of any photobiological effects on cutaneous tissue. Over the last two decades, with the development of photodynamic therapies and various dermatological treatments using visible laser light, several studies have reconsidered the cutaneous effect of visible light on the skin, in particular the induction of pigmentation.

This study intends to validate two simulators on visible light exposures with a referent solar formula on visible light protection.

Conditions

Visible Light Exposures on Healthy Back Skin

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Study Groups

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).

Visible Light Exposure - Treated zone - Left hemi-back

Intervention Type: 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.

Visible Light Exposure - Treated zone - Right hemi-back

Intervention Type: 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.

Untreated zone

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

Visible Light Exposure - Untreated zone - Left hemi-back

Intervention Type: 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.

Visible Light Exposure - Untreated zone - Right hemi-back

Intervention Type: 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.

Interventions

Visible Light Exposure - Treated zone - Left hemi-back

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.

Intervention Type: OTHER

Visible Light Exposure - Treated zone - Right hemi-back

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.

Intervention Type: OTHER

Visible Light Exposure - Untreated zone - Left hemi-back

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.

Intervention Type: OTHER

Visible Light Exposure - Untreated zone - Right hemi-back

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Healthy female or male volunteer from 18 to 50 years old

2. Skin type III-IV according to the Fitzpatrick classification

3. Average ITA° (Individual Typologic Angle calculated value) on the back between 18° and 32° at screening and inclusion visits with an allowed difference of ± 2° between screening and inclusion visits

4. Uniform skin color over the four zones (difference in ITA° between each zone should not be more than 4°)

5. Absence of freckles, naevi, hypo or hyper pigmented regions, hairs and marks of bronzing on the investigational area on the back

6. 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

7. Female of childbearing potential or menopausal female (with absence of menstruations for less than one year) willing to undergo urine pregnancy test

8. Subject willing and able to fulfil the study requirements and schedule

9. Subject informed about the study objectives and procedures, and able to understand them

10. Subject who has given written informed consent

Exclusion Criteria

1. Subject who is pregnant or lactating or who is planning to become pregnant during the study

2. Subject with BMI > 30

3. Having planned UV exposure of the investigational area (sunlight or sunbeds) throughout the study

4. Having used sunbeds or had excessive sun exposure of the investigational area within the 3 months before inclusion

5. Having sunburn (erythema) on the back

6. Dermatological disorders affecting the investigational area (presence of naevi, freckles, excess hair or uneven skin tones, vitiligo, photo-dermatological problems

7. History of skin cancer

8. History of abnormal response to sun

9. Presence of recent suntan (according to Investigator opinion) or photo-test marks

10. History of allergy, hypersensitivity, or any serious reaction to any cosmetic product

11. Any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator

12. Having used within the month before inclusion any systemic medication for more than 5 consecutive days (e.g. steroidal and non-steroidal anti-inflammatory drugs, corticoids, insulin, antihistamines, antihypertensive, antibiotics such as quinolone, tetracycline, thiazides, fluoroquinolones)

13. Having used within the month before inclusion any medication known to cause abnormal responses to UV exposure (e.g. vitamin A derivative, psoralen, aminolevulinic acid derivatives, etc.), or having planned to use these medications during the study

14. Having used within the 3 months before inclusion any depigmenting / whitening or pro-pigmenting topical treatments, or any systemic treatment that would interfere with the study assessments (anti-inflammatory drugs, corticoids, retinoids, hydroquinone, etc.) or having planned to use these treatments during the study

15. 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

16. Having planned to perform intensive sport (> 5 hours per week) or swim during the study

17. Subject who declares to be deprived of freedom by administrative or legal decision

18. Subject who cannot be contacted by telephone in case of emergency

19. Subject having participated within the 30 days before inclusion or currently participating in another clinical study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cosmetique Active International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CIDP Biotechnology S.R.L

Bucharest, , Romania

Countries

Romania

Other Identifiers

ACR_VALVI2_21-00740

Identifier Type: -

Identifier Source: org_study_id