HyperpigmentationNCT00884936
Identification of Gene Biomarkers in Aging Skin
An observational study of Hyperpigmentation and Skin Aging, run by Interleukin Genetics, Inc. at 1 site in Japan.
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… Read more about this study
- Who is it for?
- Ages 20 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperpigmentation, Skin Aging
- How many people
- 121 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2008to Apr 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Asian female subjects between the ages of 20 to 75 years old who are non-smokers with no history of prior alcoholism.
Who may be able to join
- 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.
Who cannot join
- Male gender
- Individuals who did not fit the 'inclusion criteria' above.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Thomas J. Stephens & Associates, Japan Research Center
Tokyo, 114-0002
About this study
Official title: Identification of Gene Biomarkers in Aging Skin; a Blinded, Prospective, Single-center, Clinical Study
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.
Read the detailed description
The primary objective of the skin aging study is to investigate changes in gene expression patterns that occur during the aging process.
- Conditions
- Hyperpigmentation, Skin Aging
- Keywords
- Skin, Aging, Dermogenomics, Genetic, Biomarker, Dermatology
- Medical subject headings
- Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2009 (estimated)
- Study startAug 2008
- Primary completionNov 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperpigmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Interleukin Genetics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prakash Prabhakar, PhD, Study director, Interleukin GeneticsKaren Shaver, MS, Study director, Interleukin Genetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884936
- Sponsor's protocol ID
- ILI-08-112-USKAG
- Status last verified
- Oct 2009
- First submitted
- 20 Apr 2009
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Gene Biomarkers in Aging Skin; a Blinded, Prospective, Single-center, Clinical Study
- ClinicalTrials.gov ID
- NCT00884936
- Acronym / sponsor ID
- ILI-08-112-USKAG
- Conditions
- Hyperpigmentation, Skin Aging
- Keywords
- Skin, Aging, Dermogenomics, Genetic, Biomarker, Dermatology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Interleukin Genetics, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 21 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Asian female subjects between the ages of 20 to 75 years old who are non-smokers with no history of prior alcoholism.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Male gender
- Individuals who did not fit the 'inclusion criteria' above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prakash Prabhakar, PhD study director
Interleukin Genetics
Karen Shaver, MS study director
Interleukin Genetics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperpigmentation and Skin Aging, run by Interleukin Genetics, Inc. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2015.