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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02347969
• Other study ID #: DE-87
• Status: Completed
• Phase: N/A
• First received: January 16, 2015
• Last updated: September 20, 2016
• Start date: October 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Nutratech Conseils
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT02352415

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• X34
Dietary supplement named X34

Locations

Country	Name	City	State
n/a

Sponsors (6)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin radiance: clinical scoring		At 0 week and 8 weeks	No
Secondary	Subject self-assessments	Subjects will evaluate the radiance of their complexion by self-assessment.	At 0 week and 8 weeks	No