Evaluation of the Photoprotection Efficacy with Sunscreen Formulas Under Visible Light Exposure

NCT06803901 | Completed

• 1 other identifier: 18-14124 / CPC-3554
• 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

Efficacy of Sunscreen Products; Healthy Back Skin; Pigmentation Induced by Visible Light Exposure

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)

Eligibility Criteria

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

Study Population

Twenty (20) subjects\* were screened and randomized. All completed the study as planned. \*Healthy male and female, from 18 to 50 years old, presenting with phototype III to V

You may qualify if:

• Healthy subject of both sexes aged 18 - 50 years old, having a phototype IIIb, IV or V according to Fitzpatrick classification (4),
• Subject with an ITA° (Individual Typologic Angle calculated value) between -20° and 28° at the screening visit,
• Healthy subject based on physical examination and compatibility of medical history with the study content,
• Woman 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 agreeing to continue adequate contraception during the entire duration of the study,
• Woman of non-childbearing potential (menopausal with one year without bleeding, hysterectomy, bilateral ovariectomy),
• Subject having signed a written informed consent form and dated before any study procedure begins.
• Subject willing to actively cooperate during the study duration and willing to complete the study,
• Subject affiliated to the social security system (according to 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 may have interfered 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 had been overexposed to natural (sun) or artificial ultraviolet (tanning lamps) in the last month prior the first visit or who planned a 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,
• Subject requiring enhanced protection (deprived of liberty, minors, under guardianship),
• Subject being in a situation which, according to the Investigator, could have interfered 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

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 31, 2025
• Study Start: February 4, 2019
• Primary Completion: March 22, 2019
• Study Completion: March 22, 2019
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)