Identification of Gene Biomarkers in Aging Skin
Completed
- Conditions
- HyperpigmentationSkin Aging
- Registration Number
- NCT00884936
- Lead Sponsor
- Interleukin Genetics, Inc.
- Brief Summary
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.
- Detailed Description
The primary objective of the skin aging study is to investigate changes in gene expression patterns that occur during the aging process.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 121
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. 1 year
- Secondary Outcome Measures
Name Time Method Secondary outcome measures are the evaluation of genetic expression changes in sun-protected and sun-exposed skin and an investigation of their biological pathways. 1 year
Trial Locations
- Locations (1)
Thomas J. Stephens & Associates, Japan Research Center
🇯🇵Tokyo, Japan