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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00172939
Other study ID # 9461700332
Secondary ID
Status Recruiting
Phase Phase 1
First received September 12, 2005
Last updated September 14, 2005
Start date June 2005
Est. completion date January 2008

Study information

Verified date March 2005
Source National Taiwan University Hospital
Contact Hsin-Su Yu, MD PHD
Phone 886-2-23562141
Email dermyu@ha.mc.ntu.edu.tw
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date January 2008
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

- healthy adults and patients with vitiligo

Exclusion Criteria:

- systemic disease

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Procedure:
foreskin from healthy adults


Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary foreskin from normal adults
See also
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