Clinical trial NCT01438047: Optical Frequency Domain Imaging (OFDI) in Dermatology
Official title: OFDI in Dermatology
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Port Wine Stain
Keywords: Port Wine Stain
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2011-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 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 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.

Primary outcomes:
measure: OFDI in Dermatology - Change from baseline in vascular density
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: BWH
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Benjamin J Vakoc, PhD
role: PRINCIPAL_INVESTIGATOR
References: