Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00351689
Status:
COMPLETED
Last Update Posted:
2012-10-03
First Post:
2006-07-12
Brief Title:
Placebo-controlled Assessment of the Effect of a Food Supplement on Skin Protection After Exposure to UV Radiation
Sponsor:
LOreal
Organization:
LOreal
Study Overview
Official Title:
Placebo-controlled Assessment of the Effect of a Food Supplement on Skin Protection After Exposure to UV Radiation
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
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:
A probiotic bacterial strain was tested in a randomized double blind placebo controlled clinical trial with 54 healthy male volunteers Half the volunteers received the dietary supplement the other half placebo during 6 weeks prior to exposure to solar-simulated UV irradition 2x15MED Blister roofs and skin biopsies were recovered 1 4 and 10 days after UV exposure from unirradiated and irradiated skin and used for immunohistochemical analysis and mixed epidermal cell lymphocyte reaction
Detailed Description:
Langerhans cells LC the dendritic cells DC from epidermis constitute the first line of immune defense against environmental attacks Under steady state conditions LC turnover is very low The LCs reside in the epidermis in an immature state and can be distinguished from other epidermal cells by their surface expression of HLA-DR CD1a and langerin Upon stimulation by inflammatory mediators LCs are activated and acquire CCR7 expression the chemokine receptor for CCL21 that mediates their migration to lymph nodes Moreover activated LCs display a mature phenotype characterized by increased expression of co-stimulatory molecules and acquisition of maturation markers that facilitate their interaction with T-cells and aid in the elicitation of the immune response
It has long been known that in addition to being carcinogenic via DNA damage and mutations solar UV radiation induces local and systemic immune suppression which represents a major risk for skin cancer induction and progression in sun-exposed areas The process is mostly related to direct LC damage through induction of apoptosis and impairment of antigen-presenting function Moreover UV radiation elicits an inflammatory response and subsequent recruitment of immune cells including CD36 monocytic cells These cells colonize the epidermis in the days following UV exposure and are the major source of immunosuppressive cytokines such as IL-10 All these mechanisms ultimately lead to impaired cell-mediated reactions and establishment of immune tolerance
Nutritional intervention particularly with dietary antioxidants and vitamins has been proposed to protect against UV-induced skin damage and to a certain extent skin cancer occurrence In recent years there has been an increasing interest for probiotics defined as live microorganisms which when consumed in adequate amounts confer a health benefit upon the host Particular focus has been on species of lactic acid bacteria including Lactobacilli and Bifidobacteria that are part of the natural human intestinal microbiota Indeed it is well documented that the endogenous intestinal microbiota plays a crucial role in immune maturation gut integrity and defense against pathogens Recently it has been shown that some probiotic bacteria possess the ability to modulate the immune system at both the local and systemic levels and thereby improve immune defense mechanisms andor down-regulate immune disorders such as intestinal inflammations or allergies
The Probiotic used as the dietary supplement was isolated from healthy adult microbiota and was shown to have a strong anti-pathogenic activity against a wide range of entero-pathogens Furthermore a pre-clinical study demonstrated that it can maintain the epidermal LC density
Here we analyzed in a randomized double blind placebo controlled clinical trial whether this dietary supplement could also modulate the cutaneous immune homeostasis after solar-simulated UV exposure in humansFor this purpose we analyzed whether this dietary supplement could interfere with LC allostimulatory function and activationmaturation phenotypic status of skin DC after solar-simulated UV irradiation
It has long been known that in addition to being carcinogenic via DNA damage and mutations solar UV radiation induces local and systemic immune suppression which represents a major risk for skin cancer induction and progression in sun-exposed areas The process is mostly related to direct LC damage through induction of apoptosis and impairment of antigen-presenting function Moreover UV radiation elicits an inflammatory response and subsequent recruitment of immune cells including CD36 monocytic cells These cells colonize the epidermis in the days following UV exposure and are the major source of immunosuppressive cytokines such as IL-10 All these mechanisms ultimately lead to impaired cell-mediated reactions and establishment of immune tolerance
Nutritional intervention particularly with dietary antioxidants and vitamins has been proposed to protect against UV-induced skin damage and to a certain extent skin cancer occurrence In recent years there has been an increasing interest for probiotics defined as live microorganisms which when consumed in adequate amounts confer a health benefit upon the host Particular focus has been on species of lactic acid bacteria including Lactobacilli and Bifidobacteria that are part of the natural human intestinal microbiota Indeed it is well documented that the endogenous intestinal microbiota plays a crucial role in immune maturation gut integrity and defense against pathogens Recently it has been shown that some probiotic bacteria possess the ability to modulate the immune system at both the local and systemic levels and thereby improve immune defense mechanisms andor down-regulate immune disorders such as intestinal inflammations or allergies
The Probiotic used as the dietary supplement was isolated from healthy adult microbiota and was shown to have a strong anti-pathogenic activity against a wide range of entero-pathogens Furthermore a pre-clinical study demonstrated that it can maintain the epidermal LC density
Here we analyzed in a randomized double blind placebo controlled clinical trial whether this dietary supplement could also modulate the cutaneous immune homeostasis after solar-simulated UV exposure in humansFor this purpose we analyzed whether this dietary supplement could interfere with LC allostimulatory function and activationmaturation phenotypic status of skin DC after solar-simulated UV irradiation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None