Identification of Gene Biomarkers in Aging Skin

Skin Aging Clinical Trial

Official title:

Identification of Gene Biomarkers in Aging Skin; a Blinded, Prospective, Single-center, Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00884936
• Other study ID #: ILI-08-112-USKAG
• Status: Completed
• Phase: N/A
• First received: April 20, 2009
• Last updated: March 30, 2015
• Start date: August 2008
• Est. completion date: April 2009

Study information

• Verified date: October 2009
• Source: Interleukin Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationJapan: Institutional Review BoardJapan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: April 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperpigmentation
• Skin Aging

Locations

Country	Name	City	State
Japan	Thomas J. Stephens & Associates, Japan Research Center	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Interleukin Genetics, Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		1 year	No
Secondary	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	No