Study Stopped
3 patients enrolled, no meaningful repigmentation observed. Recruitment halted.
Treatment of Vitiligo With Low-energy Visible Light Laser
Treatment of Recalcitrant Forms of Vitiligo With a Low-energy 635 nm Visible Light Laser
1 other identifier
interventional
3
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2010
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 14, 2010
CompletedFirst Posted
Study publicly available on registry
December 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedSeptember 27, 2012
September 1, 2012
8 months
December 14, 2010
September 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent repigmentation
24 clinic visits over 12 weeks
Study Arms (1)
Laser treatment
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Iltefat H. Hamzavi, M.D.
Henry Ford Health System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dermatologist
Study Record Dates
First Submitted
December 14, 2010
First Posted
December 15, 2010
Study Start
October 1, 2010
Primary Completion
June 1, 2011
Study Completion
September 1, 2012
Last Updated
September 27, 2012
Record last verified: 2012-09