Identification of Gene Biomarkers in Aging Skin

This study has been completed.
Sponsor:
Information provided by:
Interleukin Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00884936
First received: April 20, 2009
Last updated: October 30, 2009
Last verified: October 2009
  Purpose

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.


Condition
Hyperpigmentation
Skin Aging

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Interleukin Genetics, Inc.:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 121
Study Start Date: August 2008
Study Completion Date: April 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
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)

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884936

Locations
Japan
Thomas J. Stephens & Associates, Japan Research Center
1-27-2 Oji, Kita-Ku, Tokyo, Japan, 114-0002
Sponsors and Collaborators
Interleukin Genetics, Inc.
Investigators
Study Director: Prakash Prabhakar, PhD Interleukin Genetics
Study Director: Karen Shaver, MS Interleukin Genetics
  More Information

No publications provided

Responsible Party: K. Shaver, Director of Clinical Operations, Interleukin Genetics, Inc.
ClinicalTrials.gov Identifier: NCT00884936     History of Changes
Other Study ID Numbers: ILI-08-112-USKAG
Study First Received: April 20, 2009
Last Updated: October 30, 2009
Health Authority: United States: Food and Drug Administration
Japan: Institutional Review Board
Japan: Ministry of Health, Labor and Welfare

Keywords provided by Interleukin Genetics, Inc.:
Skin
Aging
Dermogenomics
Genetic
Biomarker
Dermatology

Additional relevant MeSH terms:
Hyperpigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on July 20, 2014