Evaluation of the Photoprotection Efficacy of Three Sunscreen Products Under Visible Light Exposure.

NCT06796205 | Completed

• 1 other identifier: EV2106-0253 / CPC-3608
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the protective effect of three sunscreens products on the pigmentation caused 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)

  Individual Typologic Angle (ITA° - calculated value)

  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.

Secondary Outcomes (4)

• 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 / 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.

• 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 (4)

Sunscreen product 1

The test sunscreen 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: Treated zones exposed with Visible Light source

Sunscreen product 2

The test sunscreen 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: Treated zones exposed with Visible Light source

Sunscreen product 3

The test sunscreen 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: Treated zones exposed with Visible Light source

Untreated zone

non-treated control zone

Other: Untreated zone exposed with Visible Light source

Interventions

Treated zones exposed with Visible Light source OTHER

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

Sunscreen product 1; Sunscreen product 2; Sunscreen product 3

Untreated zone exposed with Visible Light source 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 V according to the Fitzpatrick scale and with an ITA° between -28° to 20° at Screening

You may qualify if:

• Healthy subjects of both sexes aged 18 - 50 years old, having a phototype IIIb, IV or V according to Fitzpatrick classification,
• Subject with an ITA° (Individual Typologic Angle calculated value) between -20° and 28° at the screening visit,
• Healthy subjects based on physical examination and compatibility of medical history with the study content,
• Women of childbearing potential using adequate contraception (oral contraception, intra-uterine devices, contraceptive implants or vaginal rings, tubal sections or ligations, condoms) for at least 1 month prior to first visit and agree to continue adequate contraception during the entire duration of the study,
• Women of non-childbearing potential (menopausal with one year without bleeding, hysterectomy, bilateral ovariectomy),
• Subjects having signed a written informed consent form and dated before any study procedure began.
• Subjects willing to actively cooperate during the study duration and willing to complete the study,
• Subject affiliated to the social security system (in accordance with the French Law 2004-806 and its implementing decree n°2006-477 of 26 April 2006).

You may not qualify if:

• Female who was pregnant or breast feeding or planning a pregnancy during the study,
• Subject having an underlying known disease, or surgical, physical, or medical condition that, in the opinion of the Investigator could interfere with the interpretation of the clinical trial results such as:
• History of recurrent dermatologic conditions (e.g., psoriasis, eczema, urticaria…) or suspicion/history of allergy to cosmetics,
• Any systemic or local disease pathology
• Skin abnormality (scars, excessive hair, tattoos…) at the level of the test zones (middle part of the back),
• Subject who was overexposed to natural (sun) or artificial ultraviolet (tanning lamps) in the last month prior the first visit or who planneda such exposure during the study;
• Subject having history or presenting pathologies induced or aggravated by sun exposure or having abnormal reactions to the sun (ex : photosensitive dermatitis, polymorphic light eruption, solar urticaria, systemic erythematous lupus, dermatomyositis),
• Subject having antecedents of clinically significant allergy, particularly to study product components,
• Subjects requiring enhanced protection (deprived of liberty, minors, under guardianship),
• Subject being in a situation which, according to the Investigator, could interfere with an optimal participation in the study,
• Subject under care of guardian or legal guardianship or subject hospitalized in a medical or social establishment for any reason,
• Subject unable to communicate efficiently with the Investigator or being unable to follow the study requirements.

Sponsors & Collaborators

• Cosmetique Active International: lead

Study Sites (1)

CPCAD (Centre de Pharmacologie Clinique Appliquée à la Dermatologie)

Nice, 06202, France

Location

Related Publications (1)

• Renoux P, Jouni H, Laloux C, Touti R, Vieu DL, Lamarche F, Santos SM, Bernerd F, Marionnet C. Visible Light-Induced Pigmentation: Improved In Vivo Methodology for Measuring Efficacy of 30 Products in 9 Randomised Controlled Trials and Correlation With In Vitro Assessment. Exp Dermatol. 2025 Sep;34(9):e70167. doi: 10.1111/exd.70167.

  PMID: 40922539 DERIVED

Study Design

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

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 28, 2025
• Study Start: June 9, 2021
• Primary Completion: July 16, 2021
• Study Completion: July 16, 2021
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)