VitiligoPhase 1NCT00172939
Molecular Mechanisms of Helium-Neon Laser on Melanocyte Regeneration in Skin Equivalent Vitiligo Model
A Phase 1 study testing foreskin from healthy adults in people with Vitiligo, run by National Taiwan University Hospital at 1 site in Taiwan.
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). Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vitiligo
- What is being tested?
- foreskin from healthy adults
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2005to Jan 2008
- Phase
- Phase 1
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy adults and patients with vitiligo
Who cannot join
- systemic disease
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Hsin-Su Yu, MD PHD, 886-2-23562141, dermyu@ha.mc.ntu.edu.tw
Chun-Hsuan Ho, MD
About this study
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).
Read the 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.
- Conditions
- Vitiligo
- Being tested
- foreskin from healthy adults
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foreskin from healthy adultsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
foreskin from normal adults
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2005
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hsin-Su Yu, MD PHD, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00172939
- Sponsor's protocol ID
- 9461700332
- Status last verified
- Mar 2005
- First submitted
- 12 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Mechanisms of Helium-Neon Laser on Melanocyte Regeneration in Skin Equivalent Vitiligo Model
- ClinicalTrials.gov ID
- NCT00172939
- Acronym / sponsor ID
- 9461700332
- Conditions
- Vitiligo
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2005
- Study completion
- Jan 2008
- First posted
- 15 Sep 2005 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy adults and patients with vitiligo
Key exclusion criteria (1 listed)
- systemic disease
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 |
|---|---|---|
| foreskin from healthy adults | Procedure or surgery | – |
Primary outcome
foreskin from normal adults
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2005.
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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.
Hsin-Su Yu, MD PHD study director
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?
A Phase 1 study testing foreskin from healthy adults in people with 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 15 Sep 2005. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hsin-Su Yu, MD PHD (886-2-23562141, dermyu@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
foreskin from normal adults. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2005.