Optical Frequency Domain Imaging (OFDI) in Dermatology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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Recruitment Status : Withdrawn (The study was closed due to a shift in research priorities and a lack of resources available for the project.)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
Brigham and Women's Hospital
Information provided by (Responsible Party):
Benjamin Vakoc, Massachusetts General Hospital

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.

Condition or disease
Port Wine Stain

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 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
Observational Model: Cohort
Time Perspective: Prospective
Official Title: OFDI in Dermatology
Study Start Date : September 2010
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2012

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing pulsed-dye laser for the treatment of capillary malformations at Brigham and Women's Hospital will be eligible for recruitment in this study.

Inclusion Criteria:

  1. Subjects: Fitzpatrick skin type I-VI, of either gender
  2. Subjects must be between 18 and 80 years of age.
  3. 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.
  4. Subjects are scheduled for PLD treatment of the port wine stain
  5. Subjects must be willing and able to comply with all follow-up requirements.

Exclusion Criteria:

  1. Subjects must not have active localized or systemic infections
  2. Subjects must not be on aspirin.
  3. Subjects must not be currently taking Accutane or be off Accutane for less than 6 months prior to initiation of the study.
  4. Subjects must not be participating in potentially confounding research; e.g. a clinical study of any other unapproved investigational drug or device.
  5. Subjects must not be pregnant or planning to become pregnant over the course of the study.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01438047

United States, Massachusetts
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Brigham and Women's Hospital
Principal Investigator: Benjamin J Vakoc, PhD Massachusetts General Hospital

Responsible Party: Benjamin Vakoc, Assistant Professor, Massachusetts General Hospital Identifier: NCT01438047     History of Changes
Other Study ID Numbers: 2010p001607
First Posted: September 21, 2011    Key Record Dates
Last Update Posted: April 4, 2014
Last Verified: April 2014

Keywords provided by Benjamin Vakoc, Massachusetts General Hospital:
Port Wine Stain

Additional relevant MeSH terms:
Port-Wine Stain
Hemangioma, Capillary
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type