Treatment of Vitiligo With Low-energy Visible Light Laser

Vitiligo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01259986
• Other study ID #: IRB6452
• Status: Terminated
• Phase: N/A
• First received: December 14, 2010
• Last updated: September 26, 2012
• Start date: October 2010
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: September 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitiligo

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent repigmentation		24 clinic visits over 12 weeks	No