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

NCT ID: NCT02347969

Last Updated: 2016-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

X34

Arm supplemented with X34

Group Type: EXPERIMENTAL

X34

Intervention Type: DIETARY_SUPPLEMENT

Dietary supplement named X34

Interventions

X34

Dietary supplement named X34

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Research and Studies Center on the Integument (CERT)

UNKNOWN

Sponsor Role: collaborator

University of Franche-Comté

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: collaborator

Clinical Investigation Center (CIC) INSERM 1431

UNKNOWN

Sponsor Role: collaborator

INSERM UMR1098

UNKNOWN

Sponsor Role: collaborator

Nutratech Conseils

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

DE-87

Identifier Type: -

Identifier Source: org_study_id

NCT02352415

Identifier Type: -

Identifier Source: nct_alias