AgeingGEPNCT01451476
Human Skin Aging: Clinical Parameters and Gene Expression Profiling
An observational study of Ageing, run by Stanford University at 1 site in United States.
Trial summary
Skin aging is a complex process involving genetic and environmental factors. The investigators hope to learn more about how human genes and their function can contribute to skin aging and human health. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ageing
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Dec 2015
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy females age 18 or older
Who may be able to join
- healthy female, age 18 or older,
- Fitzpatrick type 1 or 2 skin,
- able to read and understand written consent form,
- body mass index normal or overweight range,
- willing to take blood tests and donate skin samples
Who cannot join
- pregnant or lactating,
- history of cosmetic surgery affecting the face,
- use of prescription anti-aging medications for 2 weeks prior to study,
- use of dietary supplements for 2 weeks prior to study, use of tanning beds or excessive light exposure (>2 hours) in the past 2 weeks,
- medical conditions which at the discretion of the investigator will have significant impact on ability to judge subjects' skin characteristics and age, sunless tanner use in past 2 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Dermatology
Redwood City, California, 94603
About this study
Skin aging is a complex process involving genetic and environmental factors. The investigators hope to learn more about how human genes and their function can contribute to skin aging and human health.
Read the detailed description
This study includes answering a survey on prior sun exposures, donating two small pieces of skin (4mm each), one blood draw, complexion analysis, photographs, and non-invasive tests such as skin surface lipid analysis. Your blood and tissue will be sent for DNA analysis and gene expression profiling.
- Conditions
- Ageing
- Keywords
- Ageing
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 |
|---|---|---|
| Healthy females aged >=18 | Healthy female volunteers of skin type I or II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of age related gene expression changes in skin
Measured: Cross sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2011 (estimated)
- Study startMay 2010
- Primary completionApr 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgeingStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Chang, Stanford University
- Investigators
- Alfred Lane, MD, Principal investigator, Stanford UniversityAnne Chang, MD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451476
- Sponsor's protocol ID
- HSA_GEP
- Other IDs
- 003
- Acronym
- GEP
- Status last verified
- Feb 2024
- First submitted
- 11 Oct 2011
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Xu J, Spitale RC, Guan L, Flynn RA, Torre EA, Li R, Raber I, Qu K, Kern D, Knaggs HE, Chang HY, Chang AL. Novel Gene Expression Profile of Women with Intrinsic Skin Youthfulness by Whole Transcriptome Sequencing. PLoS One. 2016 Nov 9;11(11):e0165913. doi: 10.1371/journal.pone.0165913. eCollection 2016.
PubMed 27829007
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Skin Aging: Clinical Parameters and Gene Expression Profiling
- ClinicalTrials.gov ID
- NCT01451476
- Acronym / sponsor ID
- GEP / HSA_GEP
- Conditions
- Ageing
- Keywords
- Ageing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Apr 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 Oct 2011 (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.
Skin aging is a complex process involving genetic and environmental factors. The investigators hope to learn more about how human genes and their function can contribute to skin aging and human health.
Detailed description
This study includes answering a survey on prior sun exposures, donating two small pieces of skin (4mm each), one blood draw, complexion analysis, photographs, and non-invasive tests such as skin surface lipid analysis. Your blood and tissue will be sent for DNA analysis and gene expression profiling.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy females aged >=18 | – | –Healthy female volunteers of skin type I or II |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy females age 18 or older
Key inclusion criteria (5 listed)
- healthy female, age 18 or older,
- Fitzpatrick type 1 or 2 skin,
- able to read and understand written consent form,
- body mass index normal or overweight range,
- willing to take blood tests and donate skin samples
Key exclusion criteria (5 listed)
- pregnant or lactating,
- history of cosmetic surgery affecting the face,
- use of prescription anti-aging medications for 2 weeks prior to study,
- use of dietary supplements for 2 weeks prior to study, use of tanning beds or excessive light exposure (>2 hours) in the past 2 weeks,
- medical conditions which at the discretion of the investigator will have significant impact on ability to judge subjects' skin characteristics and age, sunless tanner use in past 2 weeks
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
Assessment of age related gene expression changes in skin
Time frame: Cross sectional
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 9 Feb 2024.
- Results publication: PubMed 27829007Xu J, Spitale RC, Guan L, Flynn RA, Torre EA, Li R, Raber I, Qu K, Kern D, Knaggs HE, Chang HY, Chang AL. Novel Gene Expression Profile of Women with Intrinsic Skin Youthfulness by Whole Transcriptome Sequencing. PLoS One. 2016 Nov 9;11(11):e0165913. doi: 10.1371/journal.pone.0165913. eCollection 2016.
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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.
Alfred Lane, MD principal investigator
Stanford University
Anne Chang, MD study director
Stanford University
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 Ageing, run by Stanford University at 1 site in United States.
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 5 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 9 Feb 2024. 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 United States. 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?
Assessment of age related gene expression changes in skin (time frame: Cross sectional). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01451476, which also lists 1 linked publication.
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 9 Feb 2024.