Treatment of Vitiligo With Low-energy Visible Light Laser
This study has been terminated.
(3 patients enrolled, no meaningful repigmentation observed. Recruitment halted.)
Information provided by (Responsible Party):
Iltefat Hamzavi, Henry Ford Health System
First received: December 14, 2010
Last updated: September 26, 2012
Last verified: September 2012
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.
Procedure: Laser treatment
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Treatment of Recalcitrant Forms of Vitiligo With a Low-energy 635 nm Visible Light Laser
Primary Outcome Measures:
- Percent repigmentation [ Time Frame: 24 clinic visits over 12 weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2011 (Final data collection date for primary outcome measure)
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.
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259986
Henry Ford Health System
||Iltefat H. Hamzavi, M.D.
||Henry Ford Health System
No publications provided
||Iltefat Hamzavi, Dermatologist, Henry Ford Health System
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 14, 2010
||September 26, 2012
||United States: Institutional Review Board
Keywords provided by Henry Ford Health System:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 03, 2015