Human Skin Aging: Clinical Parameters and Gene Expression... | NCT01451476

Studies
Human Skin Aging: Clinical Parameters and Gene Expression Profiling

NCT01451476

Sponsor

Stanford University

Status

Completed

Last Update Posted

Feb 9, 2024Actual

Enrollment

122Actual

Phase

Not provided

Conditions

Ageing

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
003	Other Grant/Funding Number	NuSkin International

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Apr 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Oct 11, 2011

First Submission Date that Met QC Criteria

Oct 12, 2011

First Posted Date

Oct 13, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2024

Last Update Posted Date

Feb 9, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

122Actual

Label	Type	Description	Intervention Names
Healthy females aged >=18		Healthy female volunteers of skin type I or II

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of age related gene expression changes in skin		Cross sectional

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy females age 18 or older

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alfred Lane, MD	Stanford University	Principal Investigator
Anne Chang, MD	Stanford University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford Dermatology		Redwood City	California	94603	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27829007	Result	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.