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Treatment of Vitiligo With Low-energy Visible Light Laser

This study has been terminated.
(3 patients enrolled, no meaningful repigmentation observed. Recruitment halted.)
Sponsor:
Information provided by (Responsible Party):
Iltefat Hamzavi, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT01259986
First received: December 14, 2010
Last updated: September 26, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention
Vitiligo
 Procedure: Laser treatment

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Recalcitrant Forms of Vitiligo With a Low-energy 635 nm Visible Light Laser

Resource links provided by NLM:

MedlinePlus related topics: Vitiligo
U.S. FDA Resources

Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • Percent repigmentation [ Time Frame: 24 clinic visits over 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: October 2010
Study Completion Date: September 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259986

Sponsors and Collaborators
Henry Ford Health System
Investigators
Principal Investigator: Iltefat H. Hamzavi, M.D. Henry Ford Health System
  More Information

No publications provided

Responsible Party: Iltefat Hamzavi, Dermatologist, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT01259986     History of Changes
Other Study ID Numbers: IRB6452
Study First Received: December 14, 2010
Last Updated: September 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Henry Ford Health System:
Vitiligo
Laser
Segmental vitiligo
Acral vitiligo

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013