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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Identification of Gene Biomarkers in Aging Skin; a Blinded, Prospective, Single-center, Clinical Study|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
A 4 mm punch biopsy taken from exposed and unexposed skin.
|Study Start Date:||August 2008|
|Study Completion Date:||April 2009|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Young age: 20 to 30 years old
Middle Age: 38 to 48 years old (pre-menopausal only)
Elderly Age: 60 to 75 years old (Post-menopausal only)
The primary objective of the skin aging study is to investigate changes in gene expression patterns that occur during the aging process.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00884936
|Thomas J. Stephens & Associates, Japan Research Center|
|Tokyo, Japan, 114-0002|
|Study Director:||Prakash Prabhakar, PhD||Interleukin Genetics|
|Study Director:||Karen Shaver, MS||Interleukin Genetics|