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Completed

NCT Number: NCT02347969

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.

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Key information

Conditions

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

X34

Dietary Supplement

Dietary supplement named X34

Primary outcomes

  1. Skin radiance: clinical scoring

    Time frame: At 0 week and 8 weeks

Secondary outcomes

  1. Subject self-assessments

    Time frame: At 0 week and 8 weeks

    Subjects will evaluate the radiance of their complexion by self-assessment.

Sponsors and collaborators

Lead sponsor

Nutratech Conseils

Other

Collaborators

  • 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

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 28, 2015
Registry last updated
Sep 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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