Treatment of Dilated Blood Vessels on the Cheeks With a New Yellow Laser and a Traditional Green Laser

September 11, 2018 updated by: Tampere University Hospital
The goal is to compare a novel yellow laser, based on semiconductor technology, with traditional green laser, in the treatment of cheek telangiectasias. The trial design is randomized split-face double-blinded study with 20-30 volunteers. The improvement will be assessed using a 7-point Telangiectasia Grading Scale.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Trial design: The study is a comparative randomized split-face double-blinded study without a control group. It enables a comparison between two lasers; namely the KTP laser and the investigational PHOTOLASE laser. The split-face design eliminates the individual biases and the randomization eliminates the possible small variations in the symmetry of the telangiectasias on the face. The double-blinded assessment eliminates the physicians' and the subjects' subjective and objective bias.

Methods: The subjects will be treated with a 532-nm green KTP laser and a 585-nm yellow PHOTOLASE laser; different laser on each side of a face. A total of one or two treatments will be given based on the response of the first treatment. The improvement of subjects' telangiectasia will be graded after the final treatment according to a 7-point Telangiectasia Grading Scale (TGS) by a blinded physician using images taken with Visia imaging system. The usability, reliability and treatment characteristics of PHOTOLASE laser will be qualitatively assessed by the treating physicians (not blinded).

Objectives: The primary objective is to assess how the PHOTOLASE laser compares to the KTP laser in the treatment of facial telangiectasia in terms of the treatment outcomes. The secondary objective is to assess the usability, reliability and treatment characteristics of the PHOTOLASE laser from the perspective of the user.

Study Type

Interventional

Enrollment (Actual)

24

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

  • Finland
    • Pirkanmaa
      • Lempäälä, Pirkanmaa, Finland, 33880
        • Epilaser Oy

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The subjects are required to be Finnish speaking adults with symmetrical facial telangiectasia, volunteering to participate in the clinical trial.
  • The subjects have to have a Fitzpatrick skin phototype I-IV.

Exclusion Criteria:

  • pregnancy
  • lactation
  • hemophilic condition
  • Fitzpatrick skin phototype V-VI
  • drug or alcohol abuse
  • subjects who are under guardianship
  • subjects with significant tanning less than 6 weeks prior to the treatment day.
  • unbalanced basic diseases, such as diabetes, heart disease, cancer etc.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Split-face group 1
In group 1 the left side of the face will be treated with KTP and right side with PHOTOLASE.
Device: PHOTOLASE
This is the investigational yellow laser (PHOTOLASE)
Other Names:
  • yellow laser
Device: KTP
This is the traditional green laser (KTP)
Other Names:
  • green laser
Experimental: Split-face group 2
In group 2 the right side of the face will be treated with KTP and left side with PHOTOLASE.
Device: PHOTOLASE
This is the investigational yellow laser (PHOTOLASE)
Other Names:
  • yellow laser
Device: KTP
This is the traditional green laser (KTP)
Other Names:
  • green laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TGS change
Time Frame: Before treatment and 1-2 months after the intervention.
Telangiectasia grading scale will be used to assess improvement of telangiectasia and erythema. The range of TGS is -1 to 5, where -1 means worsening of the condition, 0 means no change, 1 means 0-25% improvement, 2 means 25-50% improvement, 3 means 50-75% improvement, 4 means 75-100% improvement and 5 means total clearance.
Before treatment and 1-2 months after the intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS pain measurement
Time Frame: Immediately after intervention.
Visual Analogue Scale will be used to measure the amount of pain after the intervention. The range is 0.0 - 10.0, where 0 means no pain and 10 means worst imaginable pain. The results will be reported as a mean value and range for yellow laser and green laser separately.
Immediately after intervention.
Amount of treatment-related adverse effects using a 4-point scale.
Time Frame: Immediately after treatment and 2-3 days after treatment.
The amount of erythema, crusting, edema, purpura and blisters will be assessed separately on both sides of the face. The measurement range is 0-3, where 0 means no symptoms, 1 means mild symptoms, 2 means moderate symptoms and 3 means severe symptoms. The results will be reported as a mean value for yellow laser and green laser separately.
Immediately after treatment and 2-3 days after treatment.

Collaborators and Investigators

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

Sponsor

Tampere University Hospital

Collaborators

Tampere University of Technology

Investigators

  • Study Director: Mircea Guina, Prof, Tampere University of Technology, ORC

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)

October 1, 2017

Primary Completion (Actual)

June 9, 2018

Study Completion (Actual)

June 9, 2018

Study Registration Dates

First Submitted

February 26, 2018

First Submitted That Met QC Criteria

March 20, 2018

First Posted (Actual)

March 21, 2018

Study Record Updates

Last Update Posted (Actual)

September 13, 2018

Last Update Submitted That Met QC Criteria

September 11, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R17111

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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