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

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 Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Dietary supplement: X34

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: X34; Arm supplemented with X34	Dietary supplement: X34; Dietary supplement named X34

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Skin radiance: clinical scoring	At 0 week and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject self-assessments	Subjects will evaluate the radiance of their complexion by self-assessment.	At 0 week and 8 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: January 16, 2015
• First Submitted That Met QC Criteria: January 22, 2015
• First Posted (Estimate): January 28, 2015

Study Record Updates

• Last Update Posted (Estimate): September 21, 2016
• Last Update Submitted That Met QC Criteria: September 20, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: antioxidant; skin hydration; skin elasticity; skin radiance; skin firmness
• Other Study ID Numbers: DE-87