Clinical trial NCT03472859: Treatment of Dilated Blood Vessels on the Cheeks With a New Yellow Laser and a Traditional Green Laser
Official title: Treatment of Dilated Blood Vessels on the Cheeks With a New Yellow Laser and a Traditional Green Laser
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telangiectasia
Rosacea
Keywords: laser
lasers
KTP
semiconductor
tgs
rosacea
telangiectasia
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University of Technology
First posted: 2018-03-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: TGS change
timeFrame: Before treatment and 1-2 months after the intervention.
Secondary outcomes:
measure: VAS pain measurement
timeFrame: Immediately after intervention.
measure: Amount of treatment-related adverse effects using a 4-point scale.
timeFrame: Immediately after treatment and 2-3 days after treatment.
Other outcomes:
Locations:
city: Lempäälä
country: Finland
facility: Epilaser Oy
state: Pirkanmaa
Study officials:
affiliation: Tampere University of Technology, ORC
name: Mircea Guina, Prof
role: STUDY_DIRECTOR
References: