Optical Frequency Domain Imaging (OFDI) in Dermatology

This study has been withdrawn prior to enrollment.
(The study was closed due to a shift in research priorities and a lack of resources available for the project.)
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Benjamin Vakoc, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01438047
First received: September 19, 2011
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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
Port Wine Stain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: OFDI in Dermatology

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Enrollment: 0
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)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438047

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

No publications provided

Responsible Party: Benjamin Vakoc, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01438047     History of Changes
Other Study ID Numbers: 2010p001607
Study First Received: September 19, 2011
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Port Wine Stain

Additional relevant MeSH terms:
Port-Wine Stain
Skin Abnormalities
Congenital Abnormalities
Skin Diseases

ClinicalTrials.gov processed this record on August 26, 2014