Optical Frequency Domain Imaging (OFDI) in Dermatology

NCT01438047 | Withdrawn

• 1 other identifier: 2010p001607
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Port Wine Stain

Keywords

Port Wine Stain

Outcome Measures

Primary Outcomes (1)

• OFDI in Dermatology - Change from baseline in vascular density

  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.

  4 weeks

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Brigham and Women's Hospital: collaborator

Study Sites (1)

BWH

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Port-Wine Stain

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Benjamin J Vakoc, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: September 21, 2011
• Study Start: September 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 4, 2014

Record last verified: 2014-04

Locations

US (1)