Status:
WITHDRAWN
Optical Frequency Domain Imaging (OFDI) in Dermatology
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Brigham and Women's Hospital
Conditions:
Port Wine Stain
Eligibility:
All Genders
18-80 years
Brief Summary
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.
Detailed Description
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 pa...
Eligibility Criteria
Inclusion
- Subjects: Fitzpatrick skin type I-VI, of either gender
- Subjects must be between 18 and 80 years of age.
- Subjects must have a not previously treated port wine stain of at least 1 cm2 on either a) trunk and extremities or b) face and neck.
- Subjects are scheduled for PLD treatment of the port wine stain
- Subjects must be willing and able to comply with all follow-up requirements.
Exclusion
- Subjects must not have active localized or systemic infections
- Subjects must not be on aspirin.
- Subjects must not be currently taking Accutane or be off Accutane for less than 6 months prior to initiation of the study.
- Subjects must not be participating in potentially confounding research; e.g. a clinical study of any other unapproved investigational drug or device.
- Subjects must not be pregnant or planning to become pregnant over the course of the study.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01438047
Start Date
September 1 2010
End Date
September 1 2012
Last Update
April 4 2014
Active Locations (1)
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1
BWH
Boston, Massachusetts, United States, 02115