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

NCT ID: NCT03472859

Last Updated: 2018-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2018-06-09

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.

Conditions

Telangiectasia; Rosacea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Split-face group 1

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

Group Type: EXPERIMENTAL

PHOTOLASE

Intervention Type: DEVICE

This is the investigational yellow laser (PHOTOLASE)

KTP

Intervention Type: DEVICE

This is the traditional green laser (KTP)

Split-face group 2

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

Group Type: EXPERIMENTAL

PHOTOLASE

Intervention Type: DEVICE

This is the investigational yellow laser (PHOTOLASE)

KTP

Intervention Type: DEVICE

This is the traditional green laser (KTP)

Interventions

PHOTOLASE

This is the investigational yellow laser (PHOTOLASE)

Intervention Type: DEVICE

KTP

This is the traditional green laser (KTP)

Intervention Type: DEVICE

Other Intervention Names

yellow laser; green laser

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tampere University of Technology

OTHER

Sponsor Role: collaborator

Tampere University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mircea Guina, Prof

Role: STUDY_DIRECTOR

Tampere University of Technology, ORC

Locations

Epilaser Oy

Lempäälä, Pirkanmaa, Finland

Countries

Finland

Other Identifiers

R17111

Identifier Type: -

Identifier Source: org_study_id