NCT00884936CompletedNot Applicable
Identification of Gene Biomarkers in Aging Skin; a Blinded, Prospective, Single-center, Clinical Study
Interleukin Genetics, Inc.1 site in 1 country121 target enrollmentStarted: August 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 121
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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
- 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)
Investigators
Study Sites (1)
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