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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03472859
Other study ID # R17111
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2017
Est. completion date June 9, 2018

Study information

Verified date February 2018
Source Tampere University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date June 9, 2018
Est. primary completion date June 9, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
PHOTOLASE
This is the investigational yellow laser (PHOTOLASE)
KTP
This is the traditional green laser (KTP)

Locations

Country Name City State
Finland Epilaser Oy Lempäälä Pirkanmaa

Sponsors (2)

Lead Sponsor Collaborator
Tampere University Hospital Tampere University of Technology

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 VAS pain measurement 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.
Secondary Amount of treatment-related adverse effects using a 4-point scale. 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.
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