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

NCT03472859 | Completed

• 1 other identifier: R17111
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Telangiectasia; Rosacea

Keywords

laser; lasers; KTP; semiconductor; tgs; rosacea; telangiectasia

Outcome Measures

Primary Outcomes (1)

• TGS change

  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 Outcomes (2)

• VAS pain measurement

  Immediately after intervention.

• Amount of treatment-related adverse effects using a 4-point scale.

  Immediately after treatment and 2-3 days after treatment.

Study Arms (2)

Split-face group 1

EXPERIMENTAL

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

Device: PHOTOLASE; Device: KTP

Split-face group 2

EXPERIMENTAL

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

Device: PHOTOLASE; Device: KTP

Interventions

PHOTOLASE DEVICE

This is the investigational yellow laser (PHOTOLASE)

Also known as: yellow laser

Split-face group 1; Split-face group 2

KTP DEVICE

This is the traditional green laser (KTP)

Also known as: green laser

Split-face group 1; Split-face group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tampere University Hospital: lead
• Tampere University of Technology: collaborator

Study Sites (1)

Epilaser Oy

Lempäälä, Pirkanmaa, 33880, Finland

Location

MeSH Terms

Conditions

Telangiectasis; Rosacea

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mircea Guina, Prof

  Tampere University of Technology, ORC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 21, 2018
• Study Start: October 1, 2017
• Primary Completion: June 9, 2018
• Study Completion: June 9, 2018
• Last Updated: September 13, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)