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Efficacy of Red Light in Vitiligo

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ClinicalTrials.gov Identifier: NCT01787708
Recruitment Status : Unknown
Verified June 2015 by University of British Columbia.
Recruitment status was:  Recruiting
First Posted : February 11, 2013
Last Update Posted : July 2, 2015
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

Tracking Information
First Submitted Date  ICMJE February 4, 2013
First Posted Date  ICMJE February 11, 2013
Last Update Posted Date July 2, 2015
Study Start Date  ICMJE February 2013
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2013)
Change in the modified VASI score compared to baseline. [ Time Frame: assessments at 2, 4, 6, 8 and 10 weeks during treatment then at 4, 8, and 12 weeks post treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01787708 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Red Light in Vitiligo
Official Title  ICMJE Efficacy of Red Light in Vitiligo: A Prospective, Single-Blind Randomized Controlled Trial
Brief Summary Vitiligo is a chronic acquired disease characterized by well defined white macules and patches affecting the skin. There are many treatment modalities available for vitiligo, however, none of them cure the disease. Visible red light has been shown to stimulates melanocyte migration and proliferation resulting in repigmentation of vitiligo patches. However, there are only a few studies published on the efficacy of red light in vitiligo. This is a prospective single-blind randomized clinical trial to assess efficacy of red light in the treatment of vitiligo.
Detailed Description

Vitiligo is a chronic acquired disease characterized by well defined white macules and patches affecting the skin and mucous membranes. Mucocutaneous lesions develop secondary to selective destruction of melanocytes. The etiology of vitiligo is largely unknown but more likely to be multifactorial. There are several theories on the pathogenesis of vitiligo including mainly the autoimmune, neurohormonal, and autocytotoxic theories. The autoimmune hypothesis has the strongest evidence with alteration mainly in the cellular immune response.

There are many treatment modalities available for vitiligo, however, none of them cure the disease. These include different topical treatments, phototherapy, surgical therapy, and depigmentation therapy. Visible red light has been shown to stimulates melanocyte migration and proliferation resulting in repigmentation of vitiligo patches. However, there are only a few studies published on the efficacy of red light in vitiligo. The investigators plan on conducting a prospective single-blind randomized clinical trial to assess efficacy of red light in the treatment of vitiligo.

Study Objective To evaluate the potential for red light to induce repigmentation within vitiligo patches.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Vitiligo
Intervention  ICMJE Procedure: Red light
Study Arms  ICMJE
  • Active Comparator: Low intensity red laser

    Patients with a vitiligo patch larger than 25cm2 will be recruited. The target patch will be divided into four quadrants. Two opposite quadrants will be shielded by foil and served as control, the third quadrant will be exposed to low intensity red laser (at 3 J/cm¬2), and the fourth quadrant will be exposed to high intensity red light (at 37 J/cm¬2).

    Treatments will be given twice weekly for 10 weeks. This will be followed by assessments at 4, 8, and 12 weeks post treatment.

    Intervention: Procedure: Red light
  • Active Comparator: High intensity red light

    Patients with a vitiligo patch larger than 25cm2 will be recruited. The target patch will be divided into four quadrants. Two opposite quadrants will be shielded by foil and served as control, the third quadrant will be exposed to low intensity red laser (at 3 J/cm¬2), and the fourth quadrant will be exposed to high intensity red light (at 37 J/cm¬2).

    Treatments will be given twice weekly for 10 weeks. This will be followed by assessments at 4, 8, and 12 weeks post treatment.

    Intervention: Procedure: Red light
  • No Intervention: No treatment1 (covered)

    Patients with a vitiligo patch larger than 25cm2 will be recruited. The target patch will be divided into four quadrants. Two opposite quadrants will be shielded by foil and served as control, the third quadrant will be exposed to low intensity red laser (at 3 J/cm¬2), and the fourth quadrant will be exposed to high intensity red light (at 37 J/cm¬2).

    Treatments will be given twice weekly for 10 weeks. This will be followed by assessments at 4, 8, and 12 weeks post treatment.

  • No Intervention: No treatment2 (covered)

    Patients with a vitiligo patch larger than 25cm2 will be recruited. The target patch will be divided into four quadrants. Two opposite quadrants will be shielded by foil and served as control, the third quadrant will be exposed to low intensity red laser (at 3 J/cm¬2), and the fourth quadrant will be exposed to high intensity red light (at 37 J/cm¬2).

    Treatments will be given twice weekly for 10 weeks. This will be followed by assessments at 4, 8, and 12 weeks post treatment.

Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 6, 2013)
16
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age > 18 years.
  • Localized or generalized vitiligo that involves a non mucosal or acral site.
  • Patients should have a patch of at least 25 cm2 that shows no more than 10% repigmentation as assessed visually

Exclusion Criteria:

  • Patients who received treatment for vitiligo within the past 3 weeks.
  • Patients known to have a photosensitivity disorder
  • History of previous skin cancer.
  • History of severe medical illness or immunosuppression.
  • Pregnancy or breast-feeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01787708
Other Study ID Numbers  ICMJE H10-02235b
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Harvey Lui, MD, FRCPC University of British Columbia
PRS Account University of British Columbia
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP