Evaluation of the Effect of the Dietary Supplement X34 on... | NCT02347969

NCT02347969

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Research and Studies Center on the Integument (CERT)	UNKNOWN
University of Franche-Comté	OTHER
Centre Hospitalier Universitaire de Besancon	OTHER

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
X34	Experimental	Arm supplemented with X34	Dietary Supplement: X34

Name	Type	Description	Arm Group Labels	Other Names
X34	Dietary Supplement	Dietary supplement named X34	X34

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

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

Eligibility Module

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