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Treatment of Vitiligo With Low-energy Visible Light Laser

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01259986
Recruitment Status : Terminated (3 patients enrolled, no meaningful repigmentation observed. Recruitment halted.)
First Posted : December 15, 2010
Last Update Posted : September 27, 2012
Information provided by (Responsible Party):
Iltefat Hamzavi, Henry Ford Health System

Brief Summary:
The purpose of this study is the evaluate the efficacy of using a low-energy 635 nm visible light laser in the treatment of various recalcitrant forms of vitiligo.

Condition or disease Intervention/treatment Phase
Vitiligo Procedure: Laser treatment Not Applicable

Detailed Description:
Vitiligo is a pigmentary disorder characterized by depigmented and hypopigmented macules and patches. There are forms of vitiligo which are more resistant to treatment, including segmental vitiligo and acral vitiligo. Previous studies have shown that a low energy helium-neon (633 nm) laser can cause increased proliferation of melanocytes and repigmentation in segmental-type vitiligo. The goal of this study is to verify these results and show efficacy in other recalcitrant forms of vitiligo including acral vitiligo and post melanocyte-keratinocyte transplantation vitiligo.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Recalcitrant Forms of Vitiligo With a Low-energy 635 nm Visible Light Laser
Study Start Date : October 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo
MedlinePlus related topics: Vitiligo

Arm Intervention/treatment
Experimental: Laser treatment Procedure: Laser treatment
Laser treatment of using 635 nm laser with a dose of 3.0 J/cm^2 to small area (2cm x 2cm) of vitiligo once to twice a week for a total of 12 weeks.

Primary Outcome Measures :
  1. Percent repigmentation [ Time Frame: 24 clinic visits over 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Be at least 18 years old
  • Have active or stable segmental vitiligo on the neck or face, acral vitiligo, or have undergone recent melanocyte-keratinocyte transplantation procedure (MKTP)
  • Agree to abide by the Investigator's guidelines regarding photosensitizing drugs and photoprotection
  • Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
  • Agree to follow and undergo all study-related procedures

Exclusion Criteria:

  • Women who are lactating, pregnant, or planning to become pregnant
  • Patients with a recent history of melasma, and other disorders of pigmentation with the exception of post inflammatory hyperpigmentation
  • Patients with a known history of photosensitivity disorders
  • Photosensitizing medications may be continued throughout of the study at the discretion of the investigator
  • Patients with a known history of melanoma or non-melanoma skin cancers
  • Concomitant use of tanning beds
  • Any reason the investigator feels the patient should not participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01259986

Sponsors and Collaborators
Henry Ford Health System
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Principal Investigator: Iltefat H. Hamzavi, M.D. Henry Ford Health System
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Responsible Party: Iltefat Hamzavi, Dermatologist, Henry Ford Health System Identifier: NCT01259986    
Other Study ID Numbers: IRB6452
First Posted: December 15, 2010    Key Record Dates
Last Update Posted: September 27, 2012
Last Verified: September 2012
Keywords provided by Iltefat Hamzavi, Henry Ford Health System:
Segmental vitiligo
Acral vitiligo
Additional relevant MeSH terms:
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Pigmentation Disorders
Skin Diseases