Back to results

Treatment of Vitiligo With Low-energy Visible Light Laser

Primary Purpose

Vitiligo

Status

Terminated

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Laser treatment

About this trial

This is an interventional treatment trial for Vitiligo focused on measuring Vitiligo, Laser, Segmental vitiligo, Acral vitiligo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laser treatment

Arm Description

Outcomes

Primary Outcome Measures

Percent repigmentation

Secondary Outcome Measures

Full Information

NCT ID

NCT01259986

First Posted

December 14, 2010

Last Updated

September 26, 2012

Sponsor

Henry Ford Health System

1. Study Identification

Unique Protocol Identification Number

NCT01259986

Brief Title

Treatment of Vitiligo With Low-energy Visible Light Laser

Official Title

Treatment of Recalcitrant Forms of Vitiligo With a Low-energy 635 nm Visible Light Laser

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Terminated

Why Stopped

3 patients enrolled, no meaningful repigmentation observed. Recruitment halted.

Study Start Date

October 2010 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Henry Ford Health System

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitiligo

Keywords

Vitiligo, Laser, Segmental vitiligo, Acral vitiligo

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Laser treatment

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Laser treatment

Intervention Description

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 Measure Information:

Title

Percent repigmentation

Time Frame

24 clinic visits over 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Iltefat H. Hamzavi, M.D.

Organizational Affiliation

Henry Ford Health System

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Treatment of Vitiligo With Low-energy Visible Light Laser

We'll reach out to this number within 24 hrs