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临床试验/NCT04866797
NCT04866797Unknown不适用

A Monocenter, Double Blind Controlled Study to Assess the Photo-protector Effect of a Topical Product E212657+SPF Compare to SPF Alone Under UVDL Exposure in Healthy Volunteers

L'Oreal2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年4月29日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
2
主要终点
Biophysical non-invasive assessment of skin color by using Chromameter

研究概览

简要总结

To evaluate the photo-protector effect of BC_3 (E212657) formulated in SPF compared to SPF alone on UV Day Light induced pigmentation in healthy volunteers

详细描述

The sun emits numerous radiations, of which 10% are constituted by ultraviolet light. Only ultraviolet B (UVB, 280-320 nm) and ultraviolet A (UVA, 320-400 nm) reach the surface of the earth. Poor penetrating UVB reach only to the deepest layers of the epidermis and cause DNA damage. UVA rays pass through the epidermis and reach the dermis due to their greater penetration property. UVA mainly generate intracellular oxidative stress. We can distinguish short UVA (320-340 nm) and long UVA (340-400 nm).

Sun exposure causes short-term consequences such as sunburn and reflects a reaction erythema, inflammatory type, and stimulation of pigmentation. One of the long-term deleterious consequences is represented by the development of skin cancers, which are the most dramatic result of sun exposure and are associated with mutations resulting from DNA damage badly repaired. The other long-term consequence is illustrated by the clinical signs of photoaging, associated with a major disruption in the dermal structure, linked both the decrease in collagen content and an increase in its degradation by some enzymes in the family of MMPs (matrix metalloproteinases). At the cellular and molecular level, many genes have their basal expression modulated in response to UV exposure (transcription factors and genes involved in DNA repair, inflammation, apoptosis, cell adhesion). Chronic sun exposure is also associated with the development or aggravation of pigmentary disorders, zones of hypo- or hyperpigmentation, actinic lentigo, melasma.

To protect ourselves from harmful effects of sun exposure, solar formulas applied to the skin, constitute a "barrier" against UV radiation. Currently, the most efficient sunscreen formulas from the market can absorb very efficiently and most of UVB and UVA rays. However, a part of long UVA (370-400nm) is not absorbed by these formulas, while these wavelengths seem to be involved in the generation of adverse biological effects on the skin, which may participate in clinical consequences of sun exposure, such as photo-aging and carcinogenesis. Biologically these wavelengths have been found to induce alteration at the tissue level, in particular the dermal layer, but also at the cellular and molecular levels, with for example the generation of oxidative stress and DNA damage.

Internal in vitro studies on skin cells in culture or on reconstructed skin showed that long UVA were the generators of oxidative stress, damage to DNA, cytotoxicity and modulation of genes or proteins involved in inflammation, the response to oxidative stress or photo-aging.

New sunscreens that are able to absorb beyond 370 nm, are now available. We have shown in an in vitro cultured cells or reconstructed skin that adding this type of filter in a state of the art formulation, allowed to shift the absorption spectrum beyond 370 nm and more. Thus it is possible to significantly reduce the biological impact of UVA long. These in vitro results strongly suggest a gain of biological protection by shifting the spectrum absorption beyond 370 nm.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy female or male volunteer;
  • 18 to 40 years old;
  • uniform skin color all over on the investigational zones;
  • skin type III or IV according to the Fitzpatrick classification;
  • ITA° between 10° and 35° at screening and inclusion visit with an authorize delta of ± 2° between screening and inclusion visit (Individual Typologic Angle calculated value);
  • female of childbearing potential who are sexually actives using a reliable mean of contraception (for at least three month before the beginning of the study, and throughout the study);
  • Female of childbearing potential willing to undergo urine pregnancy test
  • informed about the study objectives and procedures, and able to understand them;
  • Able to stay on the prone position more than 2 hours.
  • willing and able to fulfill the study requirements and schedule.
  • All subjects will have to give their written informed consent.

排除标准

  • Female in pregnancy (positive pregnancy-test performed before inclusion) or lactation or without effective contraception ;
  • having planned U.V. exposure of the investigational zones (sunlight or sunbeds) throughout the study;
  • having used sunbed or sun exposure of the investigational zones within the 3 months before inclusion;
  • having sunburn (erythema) on the back;
  • dermatological disorders affecting the investigational zones (presence of naevi, freckles, excess hair or uneven skin tones, vitiligo, photo-dermatological problems);
  • history of skin cancer;
  • history of abnormal response to sun;
  • presence of recent suntan (according to Investigator opinion) or photo-test marks;
  • history of allergy, hypersensitivity, or any serious reaction to any cosmetic product;
  • any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator;
  • having used within the month before inclusion any systemic medication for more than 5 consecutive days (e.g. steroidal and non-steroidal anti-inflammatory drugs, insulin, antihistamines, antihypertensive, antibiotics -e.g. quinolone, tetracycline, thiazides, fluoroquinolones-), or any medication known to cause abnormal responses to U.V. exposure (e.g. vitamin A derivatives, psoralen, aminolevulinic acid derivatives, etc.), or having planned to use these medications during the study;
  • having used within the 3 months before inclusion any depigmenting / whitening or propigmenting topical treatments, or any systemic treatment that would interfere with the study assessments (anti-inflammatory drugs, corticoids, retinoids, hydroquinone, etc.);
  • unable to be contacted by phone in case of emergency;
  • having participated within the 30 days before inclusion or currently participating in another clinical study.
  • Deprived of liberty by adjunction or by official decision.

结局指标

主要结局

Biophysical non-invasive assessment of skin color by using Chromameter

时间窗: Change from baseline at Day 7

Delta E, ITA, Delta a

Clinical investigator's assessment by clinical score

时间窗: Change from baseline at Day 7

Visual scoring of pigmentation from 0 to 9

次要结局

  • Safety was assessed by recording Adverse Events, including cutaneous reactions (local intolerance)(Change from baseline at Day 7)

研究者

发起方
L'Oreal
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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