Optical Frequency Domain Imaging (OFDI) in Dermatology

Port Wine Stain Clinical Trial

Official title:

OFDI in Dermatology

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01438047
• Other study ID #: 2010p001607
• Status: Withdrawn
• Phase: N/A
• First received: September 19, 2011
• Last updated: April 3, 2014
• Start date: September 2010
• Est. completion date: September 2012

Study information

• Verified date: April 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemangioma, Capillary
• Port Wine Stain
• Port-Wine Stain

Locations

Country	Name	City	State
United States	BWH	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No