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Identification of Gene Biomarkers in Aging Skin

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ClinicalTrials.gov Identifier: NCT00884936
Recruitment Status : Completed
First Posted : April 21, 2009
Last Update Posted : March 31, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Hyperpigmentation Skin Aging

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
Actual Enrollment : 121 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Identification of Gene Biomarkers in Aging Skin; a Blinded, Prospective, Single-center, Clinical Study
Study Start Date : August 2008
Primary Completion Date : November 2008
Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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)


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples With DNA
A 4 mm punch biopsy taken from exposed and unexposed skin.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00884936


Locations
Japan
Thomas J. Stephens & Associates, Japan Research Center
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

Responsible Party: Interleukin Genetics, Inc.
ClinicalTrials.gov Identifier: NCT00884936     History of Changes
Other Study ID Numbers: ILI-08-112-USKAG
First Posted: April 21, 2009    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: October 2009

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

Additional relevant MeSH terms:
Hyperpigmentation
Pigmentation Disorders
Skin Diseases