MelanocyteNCT00509314
The Mechanism of Melanocyte Self-Assembly on Biomaterials and the Functional Analysis
An observational study of Melanocyte and Vitiligo, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Melanocyte, Vitiligo
- What is being tested?
- melanocyte self-assembly and functional analysis
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2006to Dec 2016
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients receiving cosmetic removal of moles
Who cannot join
- No special exclusion criteria
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Sung-Jan Lin, MD PhD, +886-2-23123456 ext. 5323, jsjl2000tw@yahoo.com.tw
Sung-Jan Lin, MD PhD
About this study
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.
Read the 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.
- Conditions
- Melanocyte, Vitiligo
- Being tested
- melanocyte self-assembly and functional analysis
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melanocyte self-assembly and functional analysisBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2007 (estimated)
- Study startMay 2006
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MelanocyteStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Natural history
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan, National Health Research Institutes, Taiwan
- Investigators
- Sung-Jan Lin, MD PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509314
- Sponsor's protocol ID
- 9561703036
- Status last verified
- May 2006
- First submitted
- 29 Jul 2007
- Last updated
- 31 Jul 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15482829Lin 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.
PubMed 16171860
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mechanism of Melanocyte Self-Assembly on Biomaterials and the Functional Analysis
- ClinicalTrials.gov ID
- NCT00509314
- Acronym / sponsor ID
- 9561703036
- Conditions
- Melanocyte, Vitiligo
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan, National Health Research Institutes, Taiwan
- Study start
- May 2006
- Study completion
- Dec 2016 (estimated)
- First posted
- 31 Jul 2007 (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.
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.
Study design
- Observational model
- Natural history
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients receiving cosmetic removal of moles
Key exclusion criteria (1 listed)
- No special exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| melanocyte self-assembly and functional analysis | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2007.
- Background: PubMed 15482829Lin 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.
- Background: PubMed 16171860Lin 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.
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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.
Sung-Jan Lin, MD PhD principal investigator
National Taiwan University Hospital
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 Melanocyte and Vitiligo, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 31 Jul 2007. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sung-Jan Lin, MD PhD (+886-2-23123456 ext. 5323, jsjl2000tw@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00509314, which also lists 2 linked publications.
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 Jul 2007.