NCT02625012

Brief 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, 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2015

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

December 9, 2015

Status Verified

December 1, 2015

Enrollment Period

2 years

First QC Date

December 4, 2015

Last Update Submit

December 8, 2015

Conditions

Vitiligo

Keywords

Ultraviolet TherapyVitiligoMelanocytesPigmentation

Outcome Measures

Primary Outcomes (1)

  • Melanocyte phenotype

    To quantify melanocyte maturation stages in vitiliginous skin through markers

    Up to 1 year

Secondary Outcomes (3)

  • Melanocyte number

    Up to 1 year

  • Melanogenesis characteristics

    Up to 1 year

  • Melanin presence

    Up to 1 year

Study Arms (1)

Vitiligo

A serial of vitiligo patients under treatment with UVB-NB

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with clinical diagnosis of vitiligo vulgaris

You may qualify if:

  • 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

You may not qualify if:

  • Concomitant treatment or systemic diseases
  • Pregnancy
  • Drugs intake
  • Mental disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 12756094BACKGROUND

  • Castanedo-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.

    PMID: 12713553BACKGROUND

  • Picardo 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.

    PMID: 26066890BACKGROUND

  • Wu 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.

    PMID: 21545543BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Skin biopsies

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Diego Cortes-Garcia, PhD

    Universidad Autonoma de San Luis Potosi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical and research professor in Dermatology

Study Record Dates

First Submitted

December 4, 2015

First Posted

December 9, 2015

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Study Completion

April 1, 2016

Last Updated

December 9, 2015

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will not share