Optical Frequency Domain Imaging (OFDI) in Dermatology
This is a pilot exploratory study. The goal of this study is to evaluate a new imaging tool, optical frequency domain imaging (OFDI), to reveal the microvascular morphology of capillary malformations.
Port Wine Stain
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||OFDI in Dermatology|
- OFDI in Dermatology - Change from baseline in vascular density [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]There will be four times the patient is imaged using OFDI. Imaging is done to measure the vascular density within the specified area that is imaged. The first time imaging takes place is immediately prior to PDL treatment. The second in immediately following the treatment. The third and fourth imagings will be taken approximately four weeks after the initial visit. At this second visit the patient will have their second and final PDL treatment. An image will be take prior and following the PDL treatment.
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||September 2012|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
The subject population will be composed of 8 subjects meeting the inclusion and exclusion criteria. Up to 8 subjects may be enrolled for the study after obtaining written, informed consent prior to participation in the study. Recruitment will be performed by direct advertisement to subjects inside and outside Brigham and Women's Hospital (BWH), including the BWH dermatology clinic. The study patients will be managed using standard of care in practice at the BWH dermatology clinic. The study will be conducted at Brigham and Women's Hospital Dermatology Clinic where the pulsed dye laser is housed.
Patients referred to the BWH dermatology clinic will be eligible for recruitment. The study nurse/staff involved in patient enrollment will be familiar with the care of this type of patients. The medical history of these patients will be examined to determine if the study eligibility requirements are met. If the patient is selected as a potential subject, a letter will be sent about 7 days prior to their scheduled exam to ask if they would care to participate. This time frame should allow time for the patient to consider study participation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438047
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Benjamin J Vakoc, PhD||Massachusetts General Hospital|