Optical Frequency Domain Imaging (OFDI) in Dermatology
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|ClinicalTrials.gov Identifier: NCT01438047|
Recruitment Status : Withdrawn (The study was closed due to a shift in research priorities and a lack of resources available for the project.)
First Posted : September 21, 2011
Last Update Posted : April 4, 2014
|Condition or disease|
|Port Wine Stain|
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.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||OFDI in Dermatology|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||September 2012|
|Estimated Study Completion Date :||September 2012|
- OFDI in Dermatology - Change from baseline in vascular density [ Time Frame: 4 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01438047
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Benjamin J Vakoc, PhD||Massachusetts General Hospital|