Evaluate the Photoprotection Efficacy of Sunscreen Formulas Under Visible Light Exposure

NCT06796192 | Completed

• 1 other identifier: EV1705-0432
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Study the Protection Potency of Sunscreen Products Against Pigmentation Induced by 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), • Pigmentation (Delta E, Delta L\* and Delta b\* - calculated values), • Erythema (Delta a\* - 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 at Day 12..

Secondary Outcomes (2)

• 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)

Study Arms (4)

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

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 minutes after application.

Product 1; Product 2; Product 3

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 V according to the Fitzpatrick scale

You may qualify if:

• Healthy subject of both sexes, aged from 18 to 50 years, of phototype IIIb, IV or V on the Fitzpatrick scale (1988),
• Subject in good health having normal results for the physical examination and a medical antecedents compatible with the study requirements,
• Female subject of childbearing potential using a reliable means of contraception (contraceptive pill, contraceptive implant, IUD, bilateral tubal ligature/section, condoms) and accepting to not change her contraceptive status from at least one month prior to the start of the study and throughout the entire duration of the study,
• Female subject of non-childbearing potential, that was post-menopause (one year without menstruation), hysterectomy or bilateral ovariectomy,
• Subject having signed and dated the informed consent form before any study related action was initiated,
• Subject who was willing to follow the study procedures and to complete the study course,
• Subject affiliated to or beneficiary to a social security scheme (according to French legislation: Law 2004-806 and its implementing decree n°2006-477 of 26 April 2006).

You may not qualify if:

• Female who was pregnant or breastfeeding or who planned to become pregnant during the study,
• Subjects with an underlying pathology, or with a surgical, physical or medical status which, according to the investigator, could have interfered with the interpretation of the study results such as:
• Dermatological antecedents (e.g. acne, psoriasis, eczema, urticaria, etc.) or suspicion/antecedents of allergies to cosmetics,
• All systemic or local pathologies,
• Skin anomalies (scars, excessive hair, tattooing, etc.) on the test zones (back, middle section).
• Subjects having been excessively exposed to ultraviolet radiation (UV) natural (sun) or artificial (tanning salon) 2 months before the initial visit or who plans such an exposure during the study,
• Subjects having antecedents or currently presenting pathologies induced or aggravated by exposure to light or abnormal reactions to sunlight (e.g. : photosensitive dermatitis, polymorphous light reaction, benign summer light reaction, solar urticaria, systemic lupus erythematosus,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 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

Study Design

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

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 28, 2025
• Study Start: June 7, 2017
• Primary Completion: July 7, 2017
• Study Completion: July 7, 2017
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)