VitiligoUVBVITNCT02625012
Repigmentation Patterns Induced by NB-UVB and Their Relationship With Melanocytic Migration in Vitiligo
An observational study of Vitiligo, run by Juan Pablo Castanedo-Cazares.
Trial summary
Vitiligo is the most common acquired depigmented disorder of the skin characterized by destruction of melanocytes resulting in well-circumscribed achromic macules. Ultraviolet phototherapy with narrow band (UVB-NB) is currently one of the treatments of choice, because it is able to induce proliferation… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Vitiligo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Apr 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clinical diagnosis of vitiligo vulgaris
Who may be able to join
- Symmetric vitiligo
- Affected body surface greater than 15%
- Patients with follicular, marginal and diffuse repigmenting patterns
- No previous topical or systemic treatment
- Signed informed consent
Who cannot join
- Concomitant treatment or systemic diseases
- Pregnancy
- Drugs intake
- Mental disorders
About this study
Official title: Repigmentation Patterns Induced by NB-UVB and Their Relationship With Melanocytic Dynamics in Vitiligo
Vitiligo is the most common acquired depigmented disorder of the skin characterized by destruction of melanocytes resulting in well-circumscribed achromic macules. Ultraviolet phototherapy with narrow band (UVB-NB) is currently one of the treatments of choice, because it is able to induce proliferation, differentiation, maturation and migration of melanocytes. This repigmentation has distinctive patterns such as follicular, marginal, and diffuse. The aim of this study is to observe the dynamics of migration and proliferation, in vitiligo patients under UVB radiation phototherapy treatment. The investigators will evaluate this process by measuring FAK (focal adhesion kinase ) and c-Kit by immunohistochemistry and reverse transcriptase polymerase chain reaction assay.
Read the detailed description
Vitiligo is the most common acquired depigmented disorder of the skin characterized by destruction of melanocytes, which results in well-circumscribed achromic macules. Its etiology is not fully recognized but functional melanocytes may disappear by autoimmune response, oxidative stress that induces melanocytes apoptosis, and loss of cell-cell adhesion between melanocytes and keratinocytes.
Ultraviolet phototherapy with narrow band (UVB-NB) is currently one of the treatments of choice with an average response rate of 60-70% on lesions. UVB-NB phototherapy may induce immune regulation and melanogenic induction. It is also able to induce Treg cells proliferation to suppress the autoimmune response which destroys melanocytes. By the other hand, UVB-NB induces signaling of proliferation, differentiation, maturation and migration of melanocytes, playing an important role in vitiligo re-pigmentation.
Phosphorylation of focal adhesion kinase (p-FAK125) is a cytoplasmic tyrosine kinase that plays as an important component in the signal transduction of cell migration, as it modulates cytoskeletal proteins necessary for their movement. UVB-NB radiation induces migration on melanocytes cultures increasing their levels of p-FAK125 and it has been proposed as a melanocyte migration marker.
C-kit is a tyrosine kinase receptor expressed on melanoblasts and differentiated melanocytes. Ligand binding induces PI3K, MAPK and Src kinase pathways, which traduce differentiation of melanoblast into proliferating melanocytes; so its expression imply the presence of mature pigmented melanocytes. C-kit is increased in mature melanocytes after UVB exposure, but it has been show that in melanoma cases the loss of c-kit expression is involved in cancer progression , therefore c-kit signaling is also associated in migratory process. Although, different reports have been established the expression of this markers on vitiligo, is not defined this markers on the repigmentation patterns induces to UVB radiation.
UVB radiation induces repigmentation in distinctive patterns such as follicular, marginal, and diffuse. Follicular pattern is the predominant, and comes from hair follicle melanocytes. In the marginal pattern melanocytes from healthy skin are attracted to the lesion. In the diffuse pattern UVB radiation stimulates those inactive melanocytes. In contrast, achromic pattern not induces melanocyte activation. The relation between the biological behavior of melanocytes and these repigmentation patterns, may provide insights to an improved method to treat vitiligo. The aim of this study is to observe the dynamic of migration and proliferation by specific markers on the repigmentation patterns of vitiligo patients under UVB radiation phototherapy.
- Conditions
- Vitiligo
- Keywords
- Ultraviolet Therapy, Vitiligo, Melanocytes, Pigmentation
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vitiligo | A serial of vitiligo patients under treatment with UVB-NB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melanocyte phenotype
To quantify melanocyte maturation stages in vitiliginous skin through markers
Measured: Up to 1 year
Secondary outcomes (3)
Melanocyte number
To quantify the number of melanocytes in vitiliginous skin lesions
Measured: Up to 1 year
Melanogenesis characteristics
To quantify the expression of melanogenic in vitiliginous skin lesions
Measured: Up to 1 year
Melanin presence
To quantify melanin epidermal deposition in vitiliginous skin lesions
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study startJan 2014
- Primary completionJan 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for VitiligoStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juan Pablo Castanedo-Cazares
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Central "Dr. Ignacio Morones Prieto"
- Responsible party
- Sponsor-investigator, Juan Pablo Castanedo-Cazares, Universidad Autonoma de San Luis Potosí
- Investigators
- Diego Cortes-Garcia, PhD, Principal investigator, Universidad Autonoma de San Luis Potosi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625012
- Sponsor's protocol ID
- UVVIT01
- Acronym
- UVBVIT
- Status last verified
- Dec 2015
- First submitted
- 4 Dec 2015
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lepe V, Moncada B, Castanedo-Cazares JP, Torres-Alvarez MB, Ortiz CA, Torres-Rubalcava AB. A double-blind randomized trial of 0.1% tacrolimus vs 0.05% clobetasol for the treatment of childhood vitiligo. Arch Dermatol. 2003 May;139(5):581-5. doi: 10.1001/archderm.139.5.581.
PubMed 12756094Castanedo-Cazares JP, Lepe V, Moncada B. Repigmentation of chronic vitiligo lesions by following tacrolimus plus ultraviolet-B-narrow-band. Photodermatol Photoimmunol Photomed. 2003 Feb;19(1):35-6. doi: 10.1034/j.1600-0781.2003.00005.x. No abstract available.
PubMed 12713553Picardo M, Bastonini E. A New View of Vitiligo: Looking at Normal-Appearing Skin. J Invest Dermatol. 2015 Jul;135(7):1713-1714. doi: 10.1038/jid.2015.92.
PubMed 26066890Wu CS, Lan CC, Yu HS. Narrow-band UVB irradiation stimulates the migration and functional development of vitiligo-IgG antibodies-treated pigment cells. J Eur Acad Dermatol Venereol. 2012 Apr;26(4):456-64. doi: 10.1111/j.1468-3083.2011.04094.x. Epub 2011 May 4.
PubMed 21545543
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repigmentation Patterns Induced by NB-UVB and Their Relationship With Melanocytic Dynamics in Vitiligo
- ClinicalTrials.gov ID
- NCT02625012
- Acronym / sponsor ID
- UVBVIT / UVVIT01
- Conditions
- Vitiligo
- Keywords
- Ultraviolet Therapy, Vitiligo, Melanocytes, Pigmentation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Juan Pablo Castanedo-CazaresUniversity, hospital or other
- Collaborators
- Hospital Central "Dr. Ignacio Morones Prieto"
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 9 Dec 2015 (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.
Vitiligo is the most common acquired depigmented disorder of the skin characterized by destruction of melanocytes resulting in well-circumscribed achromic macules. Ultraviolet phototherapy with narrow band (UVB-NB) is currently one of the treatments of choice, because it is able to induce proliferation, differentiation, maturation and migration of melanocytes. This repigmentation has distinctive patterns such as follicular, marginal, and diffuse. The aim of this study is to observe the dynamics of migration and proliferation, in vitiligo patients under UVB radiation phototherapy treatment. The investigators will evaluate this process by measuring FAK (focal adhesion kinase ) and c-Kit by immunohistochemistry and reverse transcriptase polymerase chain reaction assay.
Detailed description
Vitiligo is the most common acquired depigmented disorder of the skin characterized by destruction of melanocytes, which results in well-circumscribed achromic macules. Its etiology is not fully recognized but functional melanocytes may disappear by autoimmune response, oxidative stress that induces melanocytes apoptosis, and loss of cell-cell adhesion between melanocytes and keratinocytes.
Ultraviolet phototherapy with narrow band (UVB-NB) is currently one of the treatments of choice with an average response rate of 60-70% on lesions. UVB-NB phototherapy may induce immune regulation and melanogenic induction. It is also able to induce Treg cells proliferation to suppress the autoimmune response which destroys melanocytes. By the other hand, UVB-NB induces signaling of proliferation, differentiation, maturation and migration of melanocytes, playing an important role in vitiligo re-pigmentation.
Phosphorylation of focal adhesion kinase (p-FAK125) is a cytoplasmic tyrosine kinase that plays as an important component in the signal transduction of cell migration, as it modulates cytoskeletal proteins necessary for their movement. UVB-NB radiation induces migration on melanocytes cultures increasing their levels of p-FAK125 and it has been proposed as a melanocyte migration marker.
C-kit is a tyrosine kinase receptor expressed on melanoblasts and differentiated melanocytes. Ligand binding induces PI3K, MAPK and Src kinase pathways, which traduce differentiation of melanoblast into proliferating melanocytes; so its expression imply the presence of mature pigmented melanocytes. C-kit is increased in mature melanocytes after UVB exposure, but it has been show that in melanoma cases the loss of c-kit expression is involved in cancer progression , therefore c-kit signaling is also associated in migratory process. Although, different reports have been established the expression of this markers on vitiligo, is not defined this markers on the repigmentation patterns induces to UVB radiation.
UVB radiation induces repigmentation in distinctive patterns such as follicular, marginal, and diffuse. Follicular pattern is the predominant, and comes from hair follicle melanocytes. In the marginal pattern melanocytes from healthy skin are attracted to the lesion. In the diffuse pattern UVB radiation stimulates those inactive melanocytes. In contrast, achromic pattern not induces melanocyte activation. The relation between the biological behavior of melanocytes and these repigmentation patterns, may provide insights to an improved method to treat vitiligo. The aim of this study is to observe the dynamic of migration and proliferation by specific markers on the repigmentation patterns of vitiligo patients under UVB radiation phototherapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitiligo | – | –A serial of vitiligo patients under treatment with UVB-NB |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinical diagnosis of vitiligo vulgaris
Key inclusion criteria (5 listed)
- Symmetric vitiligo
- Affected body surface greater than 15%
- Patients with follicular, marginal and diffuse repigmenting patterns
- No previous topical or systemic treatment
- Signed informed consent
Key exclusion criteria (4 listed)
- Concomitant treatment or systemic diseases
- Pregnancy
- Drugs intake
- Mental disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Melanocyte phenotype
Time frame: Up to 1 year
To quantify melanocyte maturation stages in vitiliginous skin through markers
3 secondary outcomes
Melanocyte number
Time frame: Up to 1 year
Melanogenesis characteristics
Time frame: Up to 1 year
Melanin presence
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
- Background: PubMed 12756094Lepe V, Moncada B, Castanedo-Cazares JP, Torres-Alvarez MB, Ortiz CA, Torres-Rubalcava AB. A double-blind randomized trial of 0.1% tacrolimus vs 0.05% clobetasol for the treatment of childhood vitiligo. Arch Dermatol. 2003 May;139(5):581-5. doi: 10.1001/archderm.139.5.581.
- Background: PubMed 12713553Castanedo-Cazares JP, Lepe V, Moncada B. Repigmentation of chronic vitiligo lesions by following tacrolimus plus ultraviolet-B-narrow-band. Photodermatol Photoimmunol Photomed. 2003 Feb;19(1):35-6. doi: 10.1034/j.1600-0781.2003.00005.x. No abstract available.
- Background: PubMed 26066890Picardo M, Bastonini E. A New View of Vitiligo: Looking at Normal-Appearing Skin. J Invest Dermatol. 2015 Jul;135(7):1713-1714. doi: 10.1038/jid.2015.92.
- Background: PubMed 21545543Wu CS, Lan CC, Yu HS. Narrow-band UVB irradiation stimulates the migration and functional development of vitiligo-IgG antibodies-treated pigment cells. J Eur Acad Dermatol Venereol. 2012 Apr;26(4):456-64. doi: 10.1111/j.1468-3083.2011.04094.x. Epub 2011 May 4.
- Individual participant dataSharing planned: No
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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.
Diego Cortes-Garcia, PhD principal investigator
Universidad Autonoma de San Luis Potosi
Questions about this trial
What is this clinical trial studying?
An observational study of Vitiligo, run by Juan Pablo Castanedo-Cazares.
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 5 inclusion and 4 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 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Melanocyte phenotype (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02625012, which also lists 4 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 9 Dec 2015.