The Mechanism of Melanocyte Self-Assembly on Biomaterials... | NCT00509314

Studies
The Mechanism of Melanocyte Self-Assembly on Biomaterials and the Functional Analysis

NCT00509314

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Jul 31, 2007Estimated

Enrollment

400Estimated

Phase

Not provided

Conditions

Melanocyte
Vitiligo

Interventions

melanocyte self-assembly and functional analysis

Countries

Taiwan

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

Status Module

Record Verification Date

May 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Not provided

Completion Date

Dec 2016Estimated

First Submitted Date

Jul 29, 2007

First Submission Date that Met QC Criteria

Jul 29, 2007

First Posted Date

Jul 31, 2007Estimated

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

Jul 29, 2007

Last Update Posted Date

Jul 31, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

National Taiwan University HospitalOTHER

Collaborators

Name	Class
National Science and Technology Council, Taiwan	OTHER_GOV
National Health Research Institutes, Taiwan	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The aim of this study is to survey melanocytes in the ability of self-assembly on biomaterials and functional analysis in vitro. Also, this study may provide a better way for treatment of vitiligo after understanding the functional aspects of melanocytes.

Detailed Description

Vitiligo is a chronic disease that causes loss of melanocyte and pigment of the skin. Traditional treatments for vitiligo including topical corticosteroids and phototherapy lead to limited clinical effects. Autologous melanocyte transplantation is another way to treat vitiligo. However, the effect is largely affected by whether cultivated melanocytes are successfully uptaken by vitiliginous skin. The aim of this study is to survey the self-assembly on biomaterials and functional analysis. In the long run, this study may provide a better way for treatment of vitiligo.

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

No data available

No data is available for this block.

Enrollment

400Estimated

Name	Type	Description	Arm Group Labels	Other Names
melanocyte self-assembly and functional analysis	Behavioral

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients receiving cosmetic removal of moles

Exclusion Criteria:

No special exclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sung-Jan Lin, MD PhD	Contact	+886-2-23123456	5323	jsjl2000tw@yahoo.com.tw

Overall Officials

Name	Affiliation	Role
Sung-Jan Lin, MD PhD	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei		100	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15482829	Background	Lin SJ, Jee SH, Hsaio WC, Lee SJ, Young TH. Formation of melanocyte spheroids on the chitosan-coated surface. Biomaterials. 2005 Apr;26(12):1413-22. doi: 10.1016/j.biomaterials.2004.05.002.
16171860	Background	Lin SJ, Jee SH, Hsiao WC, Yu HS, Tsai TF, Chen JS, Hsu CJ, Young TH. Enhanced cell survival of melanocyte spheroids in serum starvation condition. Biomaterials. 2006 Mar;27(8):1462-9. doi: 10.1016/j.biomaterials.2005.08.031. Epub 2005 Sep 19.

ID	Term
D017496	Hypopigmentation
D010859	Pigmentation Disorders
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases