Identification of Gene Biomarkers in Aging Skin
This study has been completed.
Sponsor:
Interleukin Genetics, Inc.
Information provided by:
Interleukin Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00884936
First received: April 20, 2009
Last updated: October 30, 2009
Last verified: October 2009
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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 |
|---|
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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
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 May 21, 2013