Healthy VolunteersNCT02347969
Evaluation of the Effect of the Dietary Supplement X34 on Skin Radiance of Healthy Volunteers With Dull Complexion
A study testing X34 in people with Healthy Volunteers, run by Nutratech Conseils.
Trial summary
The main objective of this trial is to evaluate the effect of the daily dose of X34 dietary supplement on skin radiance (clinical assessment) for 8 weeks. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- X34
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Mar 2016
- Phase
- Interventional
- 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 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female volunteers:
- Age: 40-70 years
- Who have a dull complexion evaluated by clinical scoring
- Phototype II to IV (annex 5)
- Non-smoking or smoking less than 5 cigarettes per day
- Did not change her eating habits, within one month before the start of the study and agreeing not change during the study
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- With no history of facial skin care (peeling, mask…) 15 days before the beginning of the study and agreeing not to perform during the study
- Volunteers accepting not changing their local treatment on face
- Who agree to avoid UV exposure (sun or tanning booth) during the study
- Who have a fixed address and are entitled to Social Security or a similar National Insurance scheme
- Who sign a written informed consent
Who cannot join
- Pregnant, nursing, or intending to become pregnant in the course of the study
- With a history of allergy or hypersensitivity to the products or one of their components
- Having use oral nutritional supplements and/or vitamin supplementation less than one month before and/or refusing not consuming nutritional supplement during the study
- Having used cosmetics and/or topical preparations containing ingredients claiming efficacy on skin radiance less than 15 days before and/or during the study
- With a dermatosis, systemic disease or treatment susceptible to interfere with the evolution of the parameters of the study or with taking the nutritional supplement
- Participation in another clinical trial evaluating skin radiance during the last month before the study
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- Participation in another clinical trial or volunteers being in the exclusion phase of such a trial, thus being unable to participate in any other one
- Who have forfeited their freedom by judiciary decision or are deemed legally incompetent
- Having perceived more than 4500 € as indemnification fees for participation in clinical trials during the preceding 12 months (including participation in this clinical trial)
- Unable to comply with the protocol constraints
- Who cannot be contacted by phone rapidly
About this study
The main objective of this trial is to evaluate the effect of the daily dose of X34 dietary supplement on skin radiance (clinical assessment) for 8 weeks.
- Conditions
- Healthy Volunteers
- Being tested
- X34
- Keywords
- antioxidant, skin radiance, skin elasticity, skin firmness, skin hydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X34Dietary supplement
Dietary supplement named X34
| Study group | Role | What they receive |
|---|---|---|
| X34 | Experimental | Arm supplemented with X34 Receives: Dietary Supplement: X34 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin radiance: clinical scoring
Measured: At 0 week and 8 weeks
Secondary outcomes (1)
Subject self-assessments
Subjects will evaluate the radiance of their complexion by self-assessment.
Measured: At 0 week and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startOct 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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 N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutratech Conseils
- Sponsor type
- University, hospital or other
- Collaborators
- Research and Studies Center on the Integument (CERT), University of Franche-Comté, Centre Hospitalier Universitaire de Besancon, Clinical Investigation Center (CIC) INSERM 1431, INSERM UMR1098
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347969
- Sponsor's protocol ID
- DE-87
- Status last verified
- Mar 2016
- First submitted
- 16 Jan 2015
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of the Dietary Supplement X34 on Skin Radiance of Healthy Volunteers With Dull Complexion
- ClinicalTrials.gov ID
- NCT02347969
- Acronym / sponsor ID
- DE-87
- Conditions
- Healthy Volunteers
- Keywords
- antioxidant, skin radiance, skin elasticity, skin firmness, skin hydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Nutratech ConseilsUniversity, hospital or other
- Collaborators
- Research and Studies Center on the Integument (CERT), University of Franche-Comté, Centre Hospitalier Universitaire de Besancon, Clinical Investigation Center (CIC) INSERM 1431, INSERM UMR1098
- Study start
- Oct 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 28 Jan 2015 (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.
The main objective of this trial is to evaluate the effect of the daily dose of X34 dietary supplement on skin radiance (clinical assessment) for 8 weeks.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| X34 | Experimental | Dietary Supplement: X34Arm supplemented with X34 |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female volunteers:
- Age: 40-70 years
- Who have a dull complexion evaluated by clinical scoring
- Phototype II to IV (annex 5)
- Non-smoking or smoking less than 5 cigarettes per day
Key exclusion criteria (11 listed)
- Pregnant, nursing, or intending to become pregnant in the course of the study
- With a history of allergy or hypersensitivity to the products or one of their components
- Having use oral nutritional supplements and/or vitamin supplementation less than one month before and/or refusing not consuming nutritional supplement during the study
- Having used cosmetics and/or topical preparations containing ingredients claiming efficacy on skin radiance less than 15 days before and/or during the study
- With a dermatosis, systemic disease or treatment susceptible to interfere with the evolution of the parameters of the study or with taking the nutritional supplement
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 |
|---|---|---|
| X34Dietary supplement named X34 | Dietary supplement | X34 |
Primary outcome
Skin radiance: clinical scoring
Time frame: At 0 week and 8 weeks
1 secondary outcome
Subject self-assessments
Time frame: At 0 week and 8 weeks
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 21 Sep 2016.
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Screening Protocol
Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing X34 in people with Healthy Volunteers, run by Nutratech Conseils.
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 11 inclusion and 11 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 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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 radiance: clinical scoring (time frame: At 0 week and 8 weeks). 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 21 Sep 2016.