Clinical trial NCT06796192: Evaluate the Photoprotection Efficacy of Sunscreen Formulas Under Visible Light Exposure
Official title: Assessment of the Protective Effect of Three Sunscreens on Visible Light Induced Pigmentation Compared with an Untreated Control Zone
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Cosmetique Active International
Sponsor class: INDUSTRY
First posted: 2025-01-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
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

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.

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.

The aim of this study was to assess the ability of sunscreens with a protective efficacy in the UV domain to prevent the pigmentation induced by Visible Light.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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:

  1. Dermatological antecedents (e.g. acne, psoriasis, eczema, urticaria, etc.) or suspicion/antecedents of allergies to cosmetics,
  2. All systemic or local pathologies,
  3. 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 ...),.
* Subjects having taken a systemic treatment for more than 5 days during the month preceding inclusion (steroids, non-steroidal anti-inflammatories such as aspirin, insulin, antihistamines, antihypertensives, antibiotics such as quinolones, tetracyclines, thiazides and fluoroquinolones, and all other photosensitising treatments) or all other treatments capable of inducing an abnormal response to UV or visible light (vitamin A derivatives, psoralen, aminolevulinic acid derivatives...) or planning to take these treatments during the study,
* Subjects having applied a local treatment on the back for more than 2 days during the 2 weeks preceding inclusion (steroids, non-steroidal anti-inflammatories, antihistamines, antibiotics) and all other cosmetic products in the previous 24 hours,
* 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 currently participating or having participated in another clinical trial during the month preceding inclusion,
* Subject unable to communicate efficiently with the Investigator or being unable to follow the study requirements.

Primary outcomes:
measure: Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE)
timeFrame: 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:
measure: Clinical investigator's assessment by using clinical scale
timeFrame: 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..
measure: Safety / Local Tolerance
timeFrame: From the informed consent signature date until the end of the study (Day 12)
Other outcomes:
Locations:
city: Nice
country: France
facility: CPCAD (Centre de Pharmacologie Clinique Appliquée à la Dermatologie)
Study officials:
References: