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Treatment of Vitiligo With Low-energy Visible Light Laser

NCT ID: NCT01259986

Last Updated: 2012-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-09-30

Brief Summary

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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

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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.

Conditions

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Vitiligo

Keywords

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Vitiligo Laser Segmental vitiligo Acral vitiligo

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laser treatment

Group Type EXPERIMENTAL

Laser treatment

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Iltefat Hamzavi

Dermatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Iltefat H. Hamzavi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Countries

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United States

Other Identifiers

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IRB6452

Identifier Type: -

Identifier Source: org_study_id