NCT04274842

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2020

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

8 months

First QC Date

February 15, 2020

Last Update Submit

February 15, 2020

Conditions

Keywords

Dynamic optical coherence tomographyfacial telangiectasiaintense pulsed lightblood vessel dimensionsselective photothermolysis

Outcome Measures

Primary Outcomes (4)

  • vessel width dimension

    measurement of vessel width on D-OCT images

    one-month follow-up

  • vessel depth dimension

    measurement of vessel depth on D-OCT images

    one-month follow-up

  • vessel blood flow

    measurement of vessel blood flow on D-OCT images

    one-month follow-up

  • Attenuation

    measurement of attenuation on D-OCT images

    one-month follow-up

Other Outcomes (2)

  • Relation of D-OCT detected vessel dimensions to clinical efficacy

    one-month follow-up

  • Relation of D-OCT detected vessel dimensions to adverse effects

    one-month follow-up

Study Arms (1)

D-OCT image observational

OTHER

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

Other: observation by D-OCT

Interventions

observation by D-OCT before, after, 1-3 days after, and 1 month after IPL treatment

D-OCT image observational

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • wounds or ulcers in area of facial telangiectasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zealand University Hospital Roskilde

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Telangiectasis

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Gregor BE Jemec, DmSc, Prof.

    Zealand University Hospital - Roskilde

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: prospective observational cohort
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD, DmsC, Head of Dpt.

Study Record Dates

First Submitted

February 15, 2020

First Posted

February 18, 2020

Study Start

February 1, 2018

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

February 18, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations