D-OCT of Facial Telangiectasia Treated With IPL

February 15, 2020 updated by: Gregor Jemec, Zealand University Hospital

Dynamic Optical Coherence Tomography Imaging of Telangiectasia Prior to Intense Pulsed Light Treatment - an Opportunity to Target Treatment?

Objectives: To examine whether dynamic Optical Coherence Tomography (OCT) could characterize vessel dimensions and blood flow of telangiectasias before and after treatment with Intense Pulsed Light (IPL).

Methods: Dynamic-OCT (D-OCT) imaged telangiectasia characterized blood vessel width and depth, blood flow, and attenuation. Measurements were done immediately before and after, 1-3 days after, and 1 month after IPL treatment. Characterization of vessel dimensions at baseline were verified by a blinded observer. At one-month follow-up, clinical improvement was characterized as good, moderate or none and possible adverse effects were described.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction Telangiectasia of the face are a common facial cosmetic disorder and may cause severe psychological distress. Facial telangiectasia may be treated with pulsed dye laser (PDL) or intense pulsed light (IPL). Clinical results are not always satisfactory and numerous treatments may be necessary to achieve acceptable results. Unexperienced operators often depend on treatment guidelines provided by the manufacturer when selecting energy settings for treatment, while more experienced operators may be guided by the immediate post-treatment biological endpoints and history of adverse events from previous treatment sessions. Thus, several treatments are often needed to determine optimal energy settings for the individual patient.

In general, light energy must be targeted to individual blood vessel dimensions, when optimizing laser or IPL treatment of vascular lesions. In clinical practice it may however be challenging to decide vessel width, vessel depth and blood flow by merely looking at the skin.

Optical coherence tomography (OCT) is a non-invasive in vivo imaging technique, which provides images of superficial skin structures. It has previously been demonstrated that OCT can visualize facial telangiectasias before and after IPL treatment. Dynamic OCT (D-OCT) adds identification and measurement of superficial cutaneous blood vessels with great certainty. Therefore, the aim of this study was to investigate whether D-OCT could be utilized to characterize vessel dimensions and blood flow of facial telangiectasias before and after IPL treatment.

Material and Methods Patients with telangiectasias visiting the Department of Dermatology for IPL treatment of telangiectasia at the Zealand University Hospital, Roskilde, between February and November 2018 were offered participation after informed consent. The study was approved by the Science Ethics Committee of Region Zealand (Approval no.: SJ-651) and the Danish Data Protection Agency (Approval no.: REG-177-2017).

D-OCT imaging was done immediately before, 1-3 days after, and one month after scheduled IPL treatment. The D-OCT scans and IPL treatments were performed by two separate physicians and the treating physician was blinded to all information obtained by D-OCT.

The IPL treatments were performed using a Palomar ICONTM Laser and Intense Pulsed Light platform applying a MaxGTM Optimized Handpiece with a dual-band wavelength of 500-670 nm and 870-1200 nm.

Dynamic OCT scans were performed by the 1305 nm VivoSight DX (Michelson Diagnostics, Kent, UK) with penetration depth of approximately 1 mm and vertical/horizontal optical resolution of less than 5/7.5 µm, respectively.

Drawn templates of appropriate facial telangiectasia ensured consistency of consecutive scans. Measurements of vessel dimensions were performed at the most evident level at horizontal images and verified by a blinded observer (PLA). A blinded (PLA) as well as an un-blinded evaluator (EHT) characterized vascular morphology at horizontal images from baseline and one-month follow-up. Clinical observations at one-month follow-up included changes in facial telangiectasia and registration of any adverse effects.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Roskilde, Denmark, 4000
        • Zealand University Hospital Roskilde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • legally competent,
  • at least 18 years of age
  • persons able to read and understand spoken and written information in Danish or English.
  • One or more facial telangiectasia

Exclusion Criteria:

  • wounds or ulcers in area of facial telangiectasia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: D-OCT image observational
Patients clinically eligible for IPL treatment of facial telangiectasia were D-OCT scanned before, after, 1-3 days after and 1 month after treatment
observation by D-OCT before, after, 1-3 days after, and 1 month after IPL treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vessel width dimension
Time Frame: one-month follow-up
measurement of vessel width on D-OCT images
one-month follow-up
vessel depth dimension
Time Frame: one-month follow-up
measurement of vessel depth on D-OCT images
one-month follow-up
vessel blood flow
Time Frame: one-month follow-up
measurement of vessel blood flow on D-OCT images
one-month follow-up
Attenuation
Time Frame: one-month follow-up
measurement of attenuation on D-OCT images
one-month follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relation of D-OCT detected vessel dimensions to clinical efficacy
Time Frame: one-month follow-up
Clinical efficacy detected as good, moderate or none
one-month follow-up
Relation of D-OCT detected vessel dimensions to adverse effects
Time Frame: one-month follow-up
Description of adverse effects
one-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Gregor BE Jemec, DmSc, Prof., Zealand University Hospital - Roskilde

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

February 15, 2020

First Submitted That Met QC Criteria

February 15, 2020

First Posted (Actual)

February 18, 2020

Study Record Updates

Last Update Posted (Actual)

February 18, 2020

Last Update Submitted That Met QC Criteria

February 15, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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