Evaluation of the Effect of the Dietary Supplement X34 on Skin Radiance of Healthy Volunteers With Dull Complexion

NCT02347969 | Completed

• 1 other identifier: DE-87
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Volunteers

Keywords

antioxidant; skin radiance; skin elasticity; skin firmness; skin hydration

Outcome Measures

Primary Outcomes (1)

• Skin radiance: clinical scoring

  At 0 week and 8 weeks

Secondary Outcomes (1)

• Subject self-assessments

  At 0 week and 8 weeks

Study Arms (1)

X34

EXPERIMENTAL

Arm supplemented with X34

Dietary Supplement: X34

Interventions

X34 DIETARY_SUPPLEMENT

Dietary supplement named X34

X34

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Nutratech Conseils: lead
• Research and Studies Center on the Integument (CERT): collaborator
• University of Franche-Comté: collaborator
• Centre Hospitalier Universitaire de Besancon: collaborator
• Clinical Investigation Center (CIC) INSERM 1431: collaborator
• INSERM UMR1098: collaborator

MeSH Terms

Interventions

1,4-bis(3-carboxy-4-hydroxyphenylethenyl)-benzene

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: January 28, 2015
• Study Start: October 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 21, 2016

Record last verified: 2016-03