Clinical trial NCT02347969: Evaluation of the Effect of the Dietary Supplement X34 on Skin Radiance of Healthy Volunteers With Dull Complexion
Official title: Evaluation of the Effect of the Dietary Supplement X34 on Skin Radiance of Healthy Volunteers With Dull Complexion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: antioxidant
skin radiance
skin elasticity
skin firmness
skin hydration
Lead sponsor: Nutratech Conseils
Sponsor class: OTHER
Collaborators: name: Research and Studies Center on the Integument (CERT)
name: University of Franche-Comté
name: Centre Hospitalier Universitaire de Besancon
name: Clinical Investigation Center (CIC) INSERM 1431
name: INSERM UMR1098
First posted: 2015-01-28
Enrollment: 35
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Skin radiance: clinical scoring
timeFrame: At 0 week and 8 weeks
Secondary outcomes:
measure: Subject self-assessments
timeFrame: At 0 week and 8 weeks
Other outcomes:
Locations:
Study officials:
References: