Identification of Gene Biomarkers in Aging Skin

NCT00884936 | Completed DMC

• 1 other identifier: ILI-08-112-USKAG
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperpigmentation; Skin Aging

Keywords

Skin; Aging; Dermogenomics; Genetic; Biomarker; Dermatology

Outcome Measures

Primary Outcomes (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.

  1 year

Secondary Outcomes (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.

  1 year

Study Arms (3)

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)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Male gender

Sponsors & Collaborators

• Interleukin Genetics, Inc.: lead

Study Sites (1)

Thomas J. Stephens & Associates, Japan Research Center

Tokyo, 114-0002, Japan

Location

Biospecimen

Retention: SAMPLES WITH DNA

A 4 mm punch biopsy taken from exposed and unexposed skin.

MeSH Terms

Conditions

Hyperpigmentation

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Prakash Prabhakar, PhD

  Interleukin Genetics

  STUDY DIRECTOR

• Karen Shaver, MS

  Interleukin Genetics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: April 21, 2009
• Study Start: August 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: April 1, 2009
• Last Updated: March 31, 2015

Record last verified: 2009-10

Locations

JP (1)