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

Tampere University Hospital

Status: Completed

Conditions: Rosacea; Telangiectasia

Treatments: Device: KTP; Device: PHOTOLASE

Study type: Interventional

Funder types: Other

Identifiers

NCT03472859

R17111

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Split-face group 1

Experimental group

Description:

In group 1 the left side of the face will be treated with KTP and right side with PHOTOLASE.

Treatment:

Device: KTP

Device: PHOTOLASE

Split-face group 2

Experimental group

Description:

In group 2 the right side of the face will be treated with KTP and left side with PHOTOLASE.

Treatment:

Device: KTP

Device: PHOTOLASE