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Completed

NCT Number: NCT00884936

Identification of Gene Biomarkers in Aging Skin

This study is a blinded, prospective, single-center, clinical study conducted in Japanese female subjects between the ages of 20-75 years. This design uses skin biopsy samples from environmentally exposed areas and unexposed (control) areas within the same subjects to assess the gene expression profile from three different age groups.

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Key information

Conditions

Hyperpigmentation Pigmentation Disorders Skin Aging Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Thomas J. Stephens & Associates, Japan Research Center

Tokyo, 114-0002, Japan

About this study

The primary objective of the skin aging study is to investigate changes in gene expression patterns that occur during the aging process.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Individuals who are willing to read and sign an informed consent form prior to participating in the study.
  • Individuals who have a temperature of less than or equal to 100 degrees F at the time of biopsy collection.
  • Individuals who had not applied any sunless tanning product on the arms within the past year.
  • Individuals with no prior history of alcoholism (or who consume fewer than 2 to 3 alcoholic beverages per day).
  • Individuals who have not consumed any anti-aging nutritional supplements (multivitamins and multiminerals are acceptable) or aspirin, NSAIDS, or other pain medication in the last 48 hours before biopsy.

Exclusion criteria

  • Male gender
  • Individuals who did not fit the 'inclusion criteria' above.

Treatment and study plan

Primary outcomes

  1. The primary objective of the study is to investigate changes in gene expression patterns that occur during the aging process. A significant fold change in differential gene expression will be >1.5 and an adjusted p-value of <0.05.

    Time frame: 1 year

Secondary outcomes

  1. Secondary outcome measures are the evaluation of genetic expression changes in sun-protected and sun-exposed skin and an investigation of their biological pathways.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Interleukin Genetics, Inc.

Industry

Registry information

Official study title

Identification of Gene Biomarkers in Aging Skin; a Blinded, Prospective, Single-center, Clinical Study

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Apr 21, 2009
Registry last updated
Mar 31, 2015

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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