Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04865094
Status:
UNKNOWN
Last Update Posted:
2021-04-29
First Post:
2021-04-26
Brief Title:
Photoprotection Efficacy With Sunscreen Formulas Containing the Cyclic Merocyanine Long-UVA Absorber MCE Under Long-UVA Exposure
Sponsor:
LOreal
Organization:
LOreal
Study Overview
Official Title:
A Monocenter Double-blind Comparative Controlled Randomized Study to Evaluate the Effect of E212657 Compared to Placebo on Long UVA Induced Pigmentation in Healthy Volunteers
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the photo-protector effect of BC_3 E212657 formulated in SPF compared to SPF alone on long-UVA induced pigmentation in healthy volunteers
Detailed Description:
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
The purpose of this clinical proof of concept study is to demonstrate that the addition of the Merocyanine BC_3 E212657 a new long UVA filter in a reference formula improves protection against a long UVA exposure in vivo in human Safety studies have demonstrated that BC_3 E212657 is a safe product Non phototoxic non irritant non sensitizer non photosensitizer and non Genotoxic In vitro studies have shown versus reference a photo-protector effect on fibroblast MMP1 and Cytokines after an 60Jcm² exposure
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
The purpose of this clinical proof of concept study is to demonstrate that the addition of the Merocyanine BC_3 E212657 a new long UVA filter in a reference formula improves protection against a long UVA exposure in vivo in human Safety studies have demonstrated that BC_3 E212657 is a safe product Non phototoxic non irritant non sensitizer non photosensitizer and non Genotoxic In vitro studies have shown versus reference a photo-protector effect on fibroblast MMP1 and Cytokines after an 60Jcm² exposure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None