Rosacea Clinical Trial
Official title:
Treatment of Dilated Blood Vessels on the Cheeks With a New Yellow Laser and a Traditional Green Laser
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 |
Verified date | February 2018 |
Source | Tampere University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Finland | Epilaser Oy | Lempäälä | Pirkanmaa |
Lead Sponsor | Collaborator |
---|---|
Tampere University Hospital | Tampere University of Technology |
Finland,
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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