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Identification of Gene Biomarkers in Aging Skin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00884936
Recruitment Status : Completed
First Posted : April 21, 2009
Last Update Posted : March 31, 2015
Sponsor:
Information provided by (Responsible Party):
Interleukin Genetics, Inc.

Tracking Information
First Submitted Date April 20, 2009
First Posted Date April 21, 2009
Last Update Posted Date March 31, 2015
Study Start Date August 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 20, 2009)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00884936 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 20, 2009)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Identification of Gene Biomarkers in Aging Skin
Official Title Identification of Gene Biomarkers in Aging Skin; a Blinded, Prospective, Single-center, Clinical Study
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 Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
A 4 mm punch biopsy taken from exposed and unexposed skin.
Sampling Method Non-Probability Sample
Study Population Asian female subjects between the ages of 20 to 75 years old who are non-smokers with no history of prior alcoholism.
Condition
  • Hyperpigmentation
  • Skin Aging
Intervention Not Provided
Study Groups/Cohorts
  • Group 1
    Young age: 20 to 30 years old
  • Group 2
    Middle Age: 38 to 48 years old (pre-menopausal only)
  • Group 3
    Elderly Age: 60 to 75 years old (Post-menopausal only)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 20, 2009)
121
Original Actual Enrollment Same as current
Actual Study Completion Date April 2009
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT00884936
Other Study ID Numbers ILI-08-112-USKAG
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Interleukin Genetics, Inc.
Study Sponsor Interleukin Genetics, Inc.
Collaborators Not Provided
Investigators
Study Director: Prakash Prabhakar, PhD Interleukin Genetics
Study Director: Karen Shaver, MS Interleukin Genetics
PRS Account Interleukin Genetics, Inc.
Verification Date October 2009