An interventional study of PHOTOLASE and KTP in Telangiectasia and Rosacea, sponsored by Tampere University Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-13.
Sponsored by Tampere University Hospital · Not applicable, Interventional, and Treatment
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.
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.
69 studies on the registry are indexed under Telangiectasis; 12 are open to participants now.
This study's enrollment of 24 is below the median of 30 across 59 interventional studies indexed under Telangiectasis.
Browse Telangiectasis studies →Tampere University Hospital is the lead sponsor of 212 studies on the registry; 56 are open to participants now.
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Exclusion Criteria:
In group 1 the left side of the face will be treated with KTP and right side with PHOTOLASE.
Device: PHOTOLASE · Device: KTP
In group 2 the right side of the face will be treated with KTP and left side with PHOTOLASE.
Device: PHOTOLASE · Device: KTP
This is the investigational yellow laser (PHOTOLASE)
Also known as: yellow laser
This is the traditional green laser (KTP)
Also known as: green laser
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.
Time frame: Before treatment and 1-2 months after the intervention.
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.
Time frame: Immediately after intervention.
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.
Time frame: Immediately after treatment and 2-3 days after treatment.
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in Jun 2018, 8 months.
Of 14 interventional studies with no phase under Telangiectasis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 27. This study's 8 months is below that.
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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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