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D-OCT of Facial Telangiectasia Treated With IPL

Primary Purpose

Telangiectasia

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
observation by D-OCT
Sponsored by
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Telangiectasia focused on measuring Dynamic optical coherence tomography, facial telangiectasia, intense pulsed light, blood vessel dimensions, selective photothermolysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zealand University Hospital Roskilde

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

D-OCT image observational

Arm Description

Patients clinically eligible for IPL treatment of facial telangiectasia were D-OCT scanned before, after, 1-3 days after and 1 month after treatment

Outcomes

Primary Outcome Measures

vessel width dimension
measurement of vessel width on D-OCT images
vessel depth dimension
measurement of vessel depth on D-OCT images
vessel blood flow
measurement of vessel blood flow on D-OCT images
Attenuation
measurement of attenuation on D-OCT images

Secondary Outcome Measures

Full Information

First Posted
February 15, 2020
Last Updated
February 15, 2020
Sponsor
Zealand University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04274842
Brief Title
D-OCT of Facial Telangiectasia Treated With IPL
Official Title
Dynamic Optical Coherence Tomography Imaging of Telangiectasia Prior to Intense Pulsed Light Treatment - an Opportunity to Target Treatment?
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
October 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zealand University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telangiectasia
Keywords
Dynamic optical coherence tomography, facial telangiectasia, intense pulsed light, blood vessel dimensions, selective photothermolysis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective observational cohort
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
D-OCT image observational
Arm Type
Other
Arm Description
Patients clinically eligible for IPL treatment of facial telangiectasia were D-OCT scanned before, after, 1-3 days after and 1 month after treatment
Intervention Type
Other
Intervention Name(s)
observation by D-OCT
Intervention Description
observation by D-OCT before, after, 1-3 days after, and 1 month after IPL treatment
Primary Outcome Measure Information:
Title
vessel width dimension
Description
measurement of vessel width on D-OCT images
Time Frame
one-month follow-up
Title
vessel depth dimension
Description
measurement of vessel depth on D-OCT images
Time Frame
one-month follow-up
Title
vessel blood flow
Description
measurement of vessel blood flow on D-OCT images
Time Frame
one-month follow-up
Title
Attenuation
Description
measurement of attenuation on D-OCT images
Time Frame
one-month follow-up
Other Pre-specified Outcome Measures:
Title
Relation of D-OCT detected vessel dimensions to clinical efficacy
Description
Clinical efficacy detected as good, moderate or none
Time Frame
one-month follow-up
Title
Relation of D-OCT detected vessel dimensions to adverse effects
Description
Description of adverse effects
Time Frame
one-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregor BE Jemec, DmSc, Prof.
Organizational Affiliation
Zealand University Hospital - Roskilde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zealand University Hospital Roskilde
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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D-OCT of Facial Telangiectasia Treated With IPL

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