Treatment of Vitiligo With Low-energy Visible Light Laser

Not Applicable

Terminated

• Conditions: Vitiligo
• Interventions: Procedure: Laser treatment

• Registration Number: NCT01259986
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-12-14
• Study First Submitted QC: 2010-12-14
• Study First Posted: 2010-12-15
• Primary Completion: 2011-06
• Status Verified: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2012-09-26
• Last Update Posted: 2012-09-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laser treatment	Laser treatment	-

Primary Outcome Measures

Name	Time	Method
Percent repigmentation	24 clinic visits over 12 weeks