PhotobiologyPhase 1NCT00351689
Placebo-controlled Assessment of the Effect of a Food Supplement on Skin Protection After Exposure to UV Radiation
A Phase 1 study testing dietary supplement in people with Photobiology, run by L'Oreal at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Photobiology
- What is being tested?
- dietary supplement
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2004to Jul 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subject
- Gender: male.
- Age: greater than 20 years and less than 40 years.
- Phototype: II or III.
- Subject having freely given his informed written consent.
- Cooperative subject, aware of the necessity for and duration of the controls, suggesting complete compliance with the protocol set up by Laboratoire DERMSCAN.
- Subject with Social Security coverage.
- A priori, a low fermented milk product consumer (less than 125 g/d) who, during the study, agrees not to eat fermented milk products containing live bacteria (yogurt, cream cheese, fermented dairy products, unpasteurized cheese, etc.).
Who cannot join
- Subject deprived of freedom by a court or administrative order.
- Minor or major protected by law.
- Subject residing in a health or social care establishment.
- Patient in an emergency setting.
- Subject presenting with skin disease on the test zones.
- Subject presenting with a stable or progressive serious disease (investigator's assessment).
Show all 19Show fewer
- Immunocompromised subject.
- Subject allergic to one of the constituents of the test products or to xylocaine.
- Subject with a history of allergy to solar or UV radiation.
- Immoderate use of alcohol (more than 2 glasses of wine daily or more than 1 glass of spirits daily).
- Immoderate smoker (more than 6 cigarettes/day).
- Subject exposed to the sun or UV radiation in the last 3 months (facial exposure was authorized with use of a total-block sunscreen and sunglasses).
- Subject with cardiovascular or circulatory disease history.
- Subject with a history of skin cancer, malignant melanoma.
- Subject with a history of intestinal surgery.
- Antibiotic, corticosteroid, non-steroidal anti-inflammatory or immunosuppressant intake.
- Strenuous sports (> 5 hours per week) or naturism.
- Subject having taken a course of mineral supplements or vitamins in the 3 months preceding study initiation.
- Vegetarian or vegan diet.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Photobiology
- Being tested
- dietary supplement
- Keywords
- Probiotic bacteria, cutaneous immune homeostasis, UV radiation, dietary supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary supplementBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of food supplement effect on the functions of epidermal cells after UV radiation exposure.
Secondary outcomes (1)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2006 (estimated)
- Study startJan 2004
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhotobiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- L'Oreal
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Société des Produits Nestlé (SPN)
- Investigators
- AUDREY GUENICHE, PhD, Study director, L'OrealTIMO BUETLER, PhD, Study director, Société des Produits Nestlé (SPN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351689
- Sponsor's protocol ID
- 1030740
- Status last verified
- Oct 2012
- First submitted
- 12 Jul 2006
- Last updated
- 3 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-controlled Assessment of the Effect of a Food Supplement on Skin Protection After Exposure to UV Radiation
- ClinicalTrials.gov ID
- NCT00351689
- Acronym / sponsor ID
- 1030740
- Conditions
- Photobiology
- Keywords
- Probiotic bacteria, cutaneous immune homeostasis, UV radiation, dietary supplement
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- L'OrealIndustry (pharma, biotech, devices)
- Collaborators
- Société des Produits Nestlé (SPN)
- Study start
- Jan 2004
- Study completion
- Jul 2004
- First posted
- 13 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy subject
- Gender: male.
- Age: greater than 20 years and less than 40 years.
- Phototype: II or III.
- Subject having freely given his informed written consent.
Key exclusion criteria (19 listed)
- Subject deprived of freedom by a court or administrative order.
- Minor or major protected by law.
- Subject residing in a health or social care establishment.
- Patient in an emergency setting.
- Subject presenting with skin disease on the test zones.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary supplement | Behavioural | – |
Primary outcome
Evaluation of food supplement effect on the functions of epidermal cells after UV radiation exposure.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2012.
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Healthy
Recruiting
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Oral Submucous Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AUDREY GUENICHE, PhD study director
L'Oreal
TIMO BUETLER, PhD study director
Société des Produits Nestlé (SPN)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing dietary supplement in people with Photobiology, run by L'Oreal at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of food supplement effect on the functions of epidermal cells after UV radiation exposure.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2012.