Molecular Mechanisms of Helium-Neon Laser on Melanocyte Regeneration in Skin Equivalent Vitiligo Model
Primary Purpose
Vitiligo
Status
Unknown status
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
foreskin from healthy adults
Sponsored by
About this trial
This is an interventional diagnostic trial for Vitiligo
Eligibility Criteria
Inclusion Criteria: healthy adults and patients with vitiligo Exclusion Criteria: systemic disease
Sites / Locations
- National Taiwan University HospitalRecruiting
Outcomes
Primary Outcome Measures
foreskin from normal adults
Secondary Outcome Measures
Full Information
NCT ID
NCT00172939
First Posted
September 12, 2005
Last Updated
September 14, 2005
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00172939
Brief Title
Molecular Mechanisms of Helium-Neon Laser on Melanocyte Regeneration in Skin Equivalent Vitiligo Model
Official Title
Molecular Mechanisms of Helium-Neon Laser on Melanocyte Regeneration in Skin Equivalent Vitiligo Model
Study Type
Interventional
2. Study Status
Record Verification Date
March 2005
Overall Recruitment Status
Unknown status
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
5. Study Description
Brief Summary
This current three-year proposal aims to clarify the mechanisms of melanocyte destruction and regeneration in vitiligo lesions using both traditional cell culture and skin equivalent model (organotypic culture).
Detailed Description
Melanocytes (MCs) are melanin-producing cells of the skin that are derived from neural crest cells. Vitiligo vulgaris is a common depigmentation disorder resulting from destruction of functional MCs in the affected skin. Although this disorder affects all races and occurs in approximately 1% of the world population, its pathogenesis remains obscure. Recovery from vitiligo is initiated by the activation, proliferation, and migration of melanoblasts (MBs) to the epidermis. The subsequent maturation of MBs leads to production of melanosomes that will be transferred to the juxtaposed keratinocytes. The beam of a low-energy laser produces a temperature elevation of less than 0.5 ℃. Therefore, light-mediated reaction by such laser irradiation is referred to as biostimulation. Mitochondrial cytochrome c oxidase is considered as a photoacceptor of low-energy laser. Low-energy He-Ne laser has numberous clinical applications. Our previous studies showed that He-Ne laser irradiation can induce repigmentation in vitiligo vulgaris. However, the exact mechanisms of He-Ne laser irradiation in repigmentation are not elucidated thoroughly. In the past, we have demonstrated the coexistence of both antikertinocyte (anti-KC) and antimelanocyte (anti-MC) IgG antibodies (Abs) in vitiligo patients and explored their potential roles in vitiligo. This current three-year proposal aims to clarify the mechanisms of melanocyte destruction and regeneration in vitiligo lesions using both traditional cell culture and skin equivalent model (organotypic culture). In the first year, we shall focus on the regeneration of MCs and MBs by He-Ne laser with or without the presence of anti-MC IgG antibodies from vitiligo patients, as well as the involved photodynamic mechanisms. Our goal for the second year is to investigate the regeneration of MCs and MBs by He-Ne laser with or without the presence of anti-KC IgG antibodies from vitiligo patients. In the final year of our project, we shall explore the effects of He-Ne laser combine antibody-dependent cellular cytotoxicity (ADCC) on the regeneration of MCs and MBs. Our results will provide more information for the effectiveness of He-Ne laser irradiation in treating vitiligo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
foreskin from healthy adults
Primary Outcome Measure Information:
Title
foreskin from normal adults
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy adults and patients with vitiligo
Exclusion Criteria:
systemic disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsin-Su Yu, MD PHD
Phone
886-2-23562141
Email
dermyu@ha.mc.ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsin-Su Yu, MD PHD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsin-Su Yu, MD PHD
Phone
886-2-23562141
Email
dermyu@ha.mc.ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Chun-Hsuan Ho, MD
12. IPD Sharing Statement
Learn more about this trial
Molecular Mechanisms of Helium-Neon Laser on Melanocyte Regeneration in Skin Equivalent Vitiligo Model
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