Photoprotection Efficiency with Sunscreen Formulas Under Visible Light Exposure.

NCT06827392 | Completed

• 1 other identifier: VCA1601
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the protective effect of three Laboratoire VICHY formulations on the pigmentation caused by visible light in comparison to a non-treated control zone in healthy volunteers

Conditions

Efficiency of Agents; Against Pigmentation Induced by Visible Light Exposures

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 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).

• 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).

• 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).

Eligibility Criteria

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

Study Population

Adults meeting the inclusion and exclusion criteria and willing to adhere to the protocol and study procedures

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 a normal results at the physical examination and having medical antecedents compatible with the study requirements,
• Woman of childbearing potential using a reliable means of contraception (contraceptive pill, contraceptive implant, IUD, bilateral tubal ligature/section, condoms) and agreeing to not change her method of contraception from one month before the start of the study and for the entire duration of the study,
• Healthy woman of non-childbearing potential, that is post-menopausal (absence of menstrual bleeding for one year prior to screening, hysterectomy or bilateral ovariectomy),
• Subject having signed and dated the informed consent form before any action connected to the study was performed,
• Subject willing and able to follow all the study procedures and complete the whole study,
• Subject affiliated to a social security system (according to French legislation: Law 2004-806 and its implementing decree n°2006-477 of 26 April 2006).

You may not qualify if:

• Woman who was pregnant or lactating or who planned to become pregnant during the study period,
• Subject having an underlying pathology, or a surgical, physical or medical status which, according to the investigator, could interfere with the interpretation of the study results, such as:
• A history of dermatological problems (e.g. psoriasis, eczema, urticaria..) or a suspicion/history of allergies to cosmetics or adhesives,
• All systemic or local pathologies,
• Skin anomalies (e.g. scars, hirsutism, tattoos…) on the test zones test (middle part of the back),
• Subject having been exposed excessively to ultraviolet light (UV) either natural (sun) or artificial (tanning salon) during the 4 weeks before the screening visit or who planned to expose himself/herself during the study,
• Subject having antecedent or current pathologies induced or aggravated by exposure to light or having abnormal reactions to sunlight (e.g. photosensitive dermatitis, polymorphous light eruption, solar urticaria, systemic lupus erythematosus, dermatomyositis),
• Subject with clinically significant allergic antecedents, particularly to components of the test products
• Person requiring enhanced protection (person deprived of liberty, minor, placed under guardianship),
• Subject being in a situation which, according to the opinion of the Investigator, would have interfered with an optimal participation in the study
• Subject unable to communicate effectively with the investigator or not able to follow the study imperatives.

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: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: February 14, 2025
• Study Start: September 6, 2016
• Primary Completion: October 7, 2016
• Study Completion: October 7, 2016
• Last Updated: February 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)