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| Tracking Information | |||||||||
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| First Received Date ICMJE | July 12, 2006 | ||||||||
| Last Updated Date | July 27, 2006 | ||||||||
| Start Date ICMJE | January 2004 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
Evaluation of food supplement effect on the functions of epidermal cells after UV radiation exposure. | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00351689 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Qualitative analysis (activation and/or maturation status) of cutaneous Langerhans cells and macrophages and analysis of their location and Evaluation of the erythema, pigmentation after UV exposure, Evaluation of safety. | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Placebo-Controlled Assessment of the Effect of a Food Supplement on Skin Protection After Exposure to UV Radiation | ||||||||
| Official Title ICMJE | Placebo-Controlled Assessment of the Effect of a Food Supplement on Skin Protection After Exposure to UV Radiation | ||||||||
| 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 (2x1,5MED). 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 |
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| 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 and/or 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 humans.For this purpose, we analyzed whether this dietary supplement could interfere with LC allostimulatory function and activation/maturation phenotypic status of skin DC, after solar-simulated UV irradiation. |
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| Study Phase | Phase I | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE | Photobiology | ||||||||
| Intervention ICMJE | Behavioral: dietary supplement | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 50 | ||||||||
| Completion Date | July 2004 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 20 Years to 40 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00351689 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 1030740 | ||||||||
| Study Sponsor ICMJE | L'Oreal | ||||||||
| Collaborators ICMJE | Nestle Research Center | ||||||||
| Investigators ICMJE |
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| Information Provided By | L'Oreal | ||||||||
| Verification Date | July 2006 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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