Skin SensitivityPhase 3NCT01368224
Two Supplemented Against Skin Reactivity
A Phase 3 study testing Lactobacillus paracasei NCC 2461 and Bifidobacterium longum NCC3001 in people with Skin Sensitivity and Trans-epidermal Water Loss, run by L'Oreal at 1 site in France.
Trial summary
In recent decades, the incidence of subjects presenting reactive skin has considerably increased in industrialized countries. Probiotics are live microorganisms which, when ingested in sufficient amounts, have beneficial effects on human health. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Sensitivity, Trans-epidermal Water Loss, Clinical Score
- What is being tested?
- Lactobacillus paracasei NCC 2461 and Bifidobacterium longum NCC3001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2004to Mar 2006
- Phase
- Phase 3
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subject.
- Gender: female.
- Subject aged more than 18 years and less than 35 years (inclusive)
- Phototype: I to IV
- Caucasian race.
- For women of child-bearing potential, effective contraception for at least 12 weeks and maintained throughout the study and for 1 month after completion of the study.
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- Sensitive skin: (1) as per the subjective evaluation questionnaire in appendix 12.2. (with at least 1 positive response to one of the first 3 questions) and (2) responder to the capsaicin test at one of the 3 lowest concentrationsSubject known to have dry leg skin (clinical score of at least 2 as per the scale).
- Subject known to have rough cheek skin (clinical score of at least 3 as per the scale).
- Low consumers of fermented dairy products (less than 125 g/d) and agreeing not to eat fermented dairy products containing live bacteria (yogurt, cottage cheese, fermented dairy products, unpasteurized cheese, etc.) for the duration of the study.
Who cannot join
- Post-menopausal woman.
- Pregnant or breast-feeding woman or woman planning pregnancy during the study.
- --Volunteer with a skin disease in the test areas (particularly acne rosacea). Volunteer presenting a stable or progressive serious disease (investigator's assessment).
- Immunocompromised subject.
- Subject allergic to one of the constituents of the test products and, in particular, capsaicin or pepper.
- Alcohol intake greater than 2 glasses of wine daily or 1 glass of liquor daily.
Show all 17Show fewer
- Smoker of more than 6 cigarettes/day.
- Subject presenting excessive exposure to sunlight or UV radiation (investigator's assessment).
- Subjects regularly practicing aquatic or nautical sports.
- Subjects regularly attending a sauna.
- Subject with cardiovascular or circulatory history.
- Subject with a history of skin cancer or malignant melanoma.
- Subject with a history of intestinal surgery.
- Intake of antibiotics, corticosteroids, non-steroidal anti-inflammatories or immune-suppressants.
- Subject practicing sports for more than 5 hours per week.
- Subject having taken mineral or vitamin supplements in the 3 months preceding the study (investigator's assessment).
- Lacto-ovo-vegetarian, vegetarian.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PLACEBO-CONTROLLED STUDY OF THE EFFECT OF TWO FOOD SUPPLEMENTS ON SKIN REACTIVITY
In recent decades, the incidence of subjects presenting reactive skin has considerably increased in industrialized countries. Probiotics are live microorganisms which, when ingested in sufficient amounts, have beneficial effects on human health. The mechanism underlying the effect of probiotics involves, in part, regulation of the composition and/or metabolic activity of the intestinal microbiota.. It is postulated that following interaction of probiotics with the intestinal epithelium, associated intestinal cells become activated and consequently mediators are released into the blood circulation. Mediators, activated intestinal epithelial cells and possibly bacterial fractions might reach the skin through the bloodstream where they potentially could exert effects.The objective of this study was to assess the effects of probiotics on reactive skin symptoms. The strain Lactobacillus paracasei NCC2461 was tested alone and in combination with the strain Bifidobacterium longum NCC3001 in a randomized, double-blind study. The two strains were selected for their immune-modulatory properties demonstrated in in vitro and other preclinical studies as well as in a pilot clinical trial.
Ninety-six women presenting reactive skin were randomized to 3 groups: placebo (n = 32), L. paracasei NCC2461 alone (n = 32) and L. paracasei NCC2461 + B. longum NCC3001 (n = 32). The supplements were administered by the oral route for 58 days (1010 CFU/day).
Read more
The objective of the clinical trial was to determine, in vivo, the effect of food supplements on reactive skin symptoms (as measured by skin sensitivity and the reconstruction of barrier function post-repeated tape stripping).
The secondary objectives were to determine the effect of the food supplements on leg skin dryness and facial skin roughness and the associated biochemical, immunological and microbiological factors.
Accordingly, the subjects' skin sensitivity was determined by the capsaicin test. The reconstruction of barrier function was determined by measuring the trans-epidermal water loss (TEWL) post-repeated stripping using a SERVOMED evaporimeter. A clinical score for skin dryness and roughness was assigned by a dermatologist. The subjects also assessed their leg and facial skin dryness themselves. Each analysis was conducted at the various time points.
In parallel, assessment of the skin moisturizing factors and serum inflammatory and immune-regulatory cytokines were performed. Finally, key components of the intestinal microbiota were analyzed.
Read the detailed description
The probiotics and particularly Lactobacillus paracasei and Bifidobacterium longum are of value with respect to the homeostasis of dry and sensitive skin.
An initial study (study report No. 1020813, DERMSCAN dated 2/10/2004) showed that the combination of L. paracasei NCC2461 (ST11) with Bifidobacterium lactis NCC2818 (Bb12) induced an improvement in certain parameters related to skin reactivity. However, the probiotics have not been tested separately.
It was thus considered important to conduct a clinical trial aiming at confirming and documenting the data generated by the previous study and, also determining the specific efficacy of L. paracasei NCC2461 (ST11) on reactive skin symptoms. The latter probiotic strain was selected on the basis of its proven immune-modulatory properties (scientific dossier ST11-Nestec Benyacoub and Gueniche. Scientific evidence supporting the use of Lactobacillus paracasei NCC2461 (ST11) for Innéov. Report 11.02.2005 and references 23, 24, 31-33). The strain was combined or not with a probiotic of the Bifidobacterium genus, particularly Bifidobacterium longum NCC3001. The data generated by various preclinical studies (NRC in-house studies) and clinical studies (public) show that this probiotic strain is able to modulate immune mechanisms and could interfere with inflammatory reactions.
Moreover, the probiotic combination concept enables providing potential benefit all along the gastrointestinal tract, inducing maintenance of an optimum intestinal flora.
- Conditions
- Skin Sensitivity, Trans-epidermal Water Loss, Clinical Score, Assessment of Skin Moisturization Factors, Assessment of Serum Immune-regulatory Cytokine, Evaluation of Intestinal Flora Composition
- Being tested
- Lactobacillus paracasei NCC 2461 and Bifidobacterium longum NCC3001
- Keywords
- Skin sensitivity, Trans-epidermal water loss, Clinical score, skin moisturization factors, serum immune-regulatory cytokine, Evaluation of intestinal flora composition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus paracasei NCC 2461 and Bifidobacterium longum NCC3001Dietary supplement
1 treatment unit, in the form of a sachet of powder, to be reconstituted in a glass of water and taken once daily for 8 weeks (from D1 to D57), except if the last visit is bring forward or put back for no more than 3 days, in which case the subject will continue treatment until the final visit.
Oral route.
| Study group | Role | What they receive |
|---|---|---|
| Maltodextrin | Placebo comparator | Not described Receives: Dietary Supplement: Lactobacillus paracasei NCC 2461 and Bifidobacterium longum NCC3001 |
| Lactobacillus paracasei NCC 2461 (ST 11) | Experimental | 1x1010 CFU of Lactobacillus paracasei NCC 2461 (ST 11) Receives: Dietary Supplement: Lactobacillus paracasei NCC 2461 and Bifidobacterium longum NCC3001 |
| Lactobacillus paracasei+ Bifidobacterium longum | Experimental | 1x1010 CFU of Lactobacillus paracasei NCC 2461 (ST 11) + 1x1010 CFU of Bifidobacterium longum (NCC3001) Receives: Dietary Supplement: Lactobacillus paracasei NCC 2461 and Bifidobacterium longum NCC3001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin sensitivity and skin barrier reconstruction
determining the effect of food supplements on skin reactivity (measured by skin sensitivity and the skin barrier function reconstruction after repeated tape-stripping).
Secondary outcomes (1)
dryness , roughness, biochemical factors and safety
- determining the effect of the food supplements on leg skin dryness and facial skin roughness,
- determining the effect of the food supplements on the associated biochemical and immunological factors,
- Evaluating the safety of the study products.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startJun 2004
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin SensitivityStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- L'Oreal
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Société des Produits Nestlé (SPN)
- Investigators
- Frédéric BOUDJEMA, MD, Principal investigator, Dermscan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368224
- Sponsor's protocol ID
- 1040341
- Status last verified
- Jun 2011
- First submitted
- 6 Jun 2011
- Last updated
- 7 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLACEBO-CONTROLLED STUDY OF THE EFFECT OF TWO FOOD SUPPLEMENTS ON SKIN REACTIVITY
- ClinicalTrials.gov ID
- NCT01368224
- Acronym / sponsor ID
- 1040341
- Conditions
- Skin Sensitivity, Trans-epidermal Water Loss, Clinical Score, Assessment of Skin Moisturization Factors, Assessment of Serum Immune-regulatory Cytokine, Evaluation of Intestinal Flora Composition
- Keywords
- Skin sensitivity, Trans-epidermal water loss, Clinical score, skin moisturization factors, serum immune-regulatory cytokine, Evaluation of intestinal flora composition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- L'OrealIndustry (pharma, biotech, devices)
- Collaborators
- Société des Produits Nestlé (SPN)
- Study start
- Jun 2004
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 7 Jun 2011 (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.
In recent decades, the incidence of subjects presenting reactive skin has considerably increased in industrialized countries. Probiotics are live microorganisms which, when ingested in sufficient amounts, have beneficial effects on human health. The mechanism underlying the effect of probiotics involves, in part, regulation of the composition and/or metabolic activity of the intestinal microbiota.. It is postulated that following interaction of probiotics with the intestinal epithelium, associated intestinal cells become activated and consequently mediators are released into the blood circulation. Mediators, activated intestinal epithelial cells and possibly bacterial fractions might reach the skin through the bloodstream where they potentially could exert effects.The objective of this study was to assess the effects of probiotics on reactive skin symptoms. The strain Lactobacillus paracasei NCC2461 was tested alone and in combination with the strain Bifidobacterium longum NCC3001 in a randomized, double-blind study. The two strains were selected for their immune-modulatory properties demonstrated in in vitro and other preclinical studies as well as in a pilot clinical trial.
Ninety-six women presenting reactive skin were randomized to 3 groups: placebo (n = 32), L. paracasei NCC2461 alone (n = 32) and L. paracasei NCC2461 + B. longum NCC3001 (n = 32). The supplements were administered by the oral route for 58 days (1010 CFU/day).
The objective of the clinical trial was to determine, in vivo, the effect of food supplements on reactive skin symptoms (as measured by skin sensitivity and the reconstruction of barrier function post-repeated tape stripping).
The secondary objectives were to determine the effect of the food supplements on leg skin dryness and facial skin roughness and the associated biochemical, immunological and microbiological factors.
Accordingly, the subjects' skin sensitivity was determined by the capsaicin test. The reconstruction of barrier function was determined by measuring the trans-epidermal water loss (TEWL) post-repeated stripping using a SERVOMED evaporimeter. A clinical score for skin dryness and roughness was assigned by a dermatologist. The subjects also assessed their leg and facial skin dryness themselves. Each analysis was conducted at the various time points.
In parallel, assessment of the skin moisturizing factors and serum inflammatory and immune-regulatory cytokines were performed. Finally, key components of the intestinal microbiota were analyzed.
Detailed description
The probiotics and particularly Lactobacillus paracasei and Bifidobacterium longum are of value with respect to the homeostasis of dry and sensitive skin.
An initial study (study report No. 1020813, DERMSCAN dated 2/10/2004) showed that the combination of L. paracasei NCC2461 (ST11) with Bifidobacterium lactis NCC2818 (Bb12) induced an improvement in certain parameters related to skin reactivity. However, the probiotics have not been tested separately.
It was thus considered important to conduct a clinical trial aiming at confirming and documenting the data generated by the previous study and, also determining the specific efficacy of L. paracasei NCC2461 (ST11) on reactive skin symptoms. The latter probiotic strain was selected on the basis of its proven immune-modulatory properties (scientific dossier ST11-Nestec Benyacoub and Gueniche. Scientific evidence supporting the use of Lactobacillus paracasei NCC2461 (ST11) for Innéov. Report 11.02.2005 and references 23, 24, 31-33). The strain was combined or not with a probiotic of the Bifidobacterium genus, particularly Bifidobacterium longum NCC3001. The data generated by various preclinical studies (NRC in-house studies) and clinical studies (public) show that this probiotic strain is able to modulate immune mechanisms and could interfere with inflammatory reactions.
Moreover, the probiotic combination concept enables providing potential benefit all along the gastrointestinal tract, inducing maintenance of an optimum intestinal flora.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Maltodextrin | Placebo comparator | Dietary Supplement: Lactobacillus paracasei NCC 2461 and Bifidobacterium longum NCC3001 |
| Lactobacillus paracasei NCC 2461 (ST 11) | Experimental | Dietary Supplement: Lactobacillus paracasei NCC 2461 and Bifidobacterium longum NCC30011x1010 CFU of Lactobacillus paracasei NCC 2461 (ST 11) |
| Lactobacillus paracasei+ Bifidobacterium longum | Experimental | Dietary Supplement: Lactobacillus paracasei NCC 2461 and Bifidobacterium longum NCC30011x1010 CFU of Lactobacillus paracasei NCC 2461 (ST 11) + 1x1010 CFU of Bifidobacterium longum (NCC3001) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy subject.
- Gender: female.
- Subject aged more than 18 years and less than 35 years (inclusive)
- Phototype: I to IV
- Caucasian race.
Key exclusion criteria (17 listed)
- Post-menopausal woman.
- Pregnant or breast-feeding woman or woman planning pregnancy during the study.
- --Volunteer with a skin disease in the test areas (particularly acne rosacea). Volunteer presenting a stable or progressive serious disease (investigator's assessment).
- Immunocompromised subject.
- Subject allergic to one of the constituents of the test products and, in particular, capsaicin or pepper.
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 |
|---|---|---|
| Lactobacillus paracasei NCC 2461 and Bifidobacterium longum NCC30011 treatment unit, in the form of a sachet of powder, to be reconstituted in a glass of water and taken once daily for 8 weeks (from D1 to D57), except if the last visit is bring forward or put back for no more than 3 days, in which case the subject will continue treatment until the final visit. Oral route. | Dietary supplement | Lactobacillus paracasei NCC 2461 (ST 11), Lactobacillus paracasei+ Bifidobacterium longum, Maltodextrin |
Primary outcome
skin sensitivity and skin barrier reconstruction
determining the effect of food supplements on skin reactivity (measured by skin sensitivity and the skin barrier function reconstruction after repeated tape-stripping).
1 secondary outcome
dryness , roughness, biochemical factors and 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 7 Jun 2011.
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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.
Frédéric BOUDJEMA, MD principal investigator
Dermscan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lactobacillus paracasei NCC 2461 and Bifidobacterium longum NCC3001 in people with Skin Sensitivity and Trans-epidermal Water Loss, 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 9 inclusion and 17 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 7 Jun 2011. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
skin sensitivity and skin barrier reconstruction. 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 7 Jun 2011.