TelangiectasiaNCT03472859
Treatment of Dilated Blood Vessels on the Cheeks With a New Yellow Laser and a Traditional Green Laser
A study testing PHOTOLASE and KTP in people with Telangiectasia and Rosacea, run by Tampere University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Telangiectasia, Rosacea
- What is being tested?
- PHOTOLASE and KTP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFinland
- Study dates
- 1 Oct 2017to 9 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- PHOTOLASE, KTP
- Keywords
- laser, lasers, KTP, semiconductor, tgs, rosacea, telangiectasia
- Medical subject headings
- Telangiectasis, Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHOTOLASEDevice
Also called yellow laser
This is the investigational yellow laser (PHOTOLASE)
KTPDevice
Also called green laser
This is the traditional green laser (KTP)
| Study group | Role | What they receive |
|---|---|---|
| Split-face group 1 | Experimental | In group 1 the left side of the face will be treated with KTP and right side with PHOTOLASE. Receives: 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. Receives: Device: PHOTOLASE; Device: KTP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before treatment and 1-2 months after the intervention.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Immediately after treatment and 2-3 days after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start1 Oct 2017
- Primary completion9 Jun 2018
- Study completion9 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelangiectasiaStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University of Technology
- Responsible party
- Sponsor
- Investigators
- Mircea Guina, Prof, Study director, Tampere University of Technology, ORC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472859
- Sponsor's protocol ID
- R17111
- Status last verified
- Feb 2018
- First submitted
- 26 Feb 2018
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Dilated Blood Vessels on the Cheeks With a New Yellow Laser and a Traditional Green Laser
- ClinicalTrials.gov ID
- NCT03472859
- Acronym / sponsor ID
- R17111
- Conditions
- Telangiectasia, Rosacea
- Keywords
- laser, lasers, KTP, semiconductor, tgs, rosacea, telangiectasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere University of Technology
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 9 Jun 2018 (actual)
- Study completion
- 9 Jun 2018 (actual)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Split-face group 1 | Experimental | Device: PHOTOLASE, Device: KTPIn group 1 the left side of the face will be treated with KTP and right side with PHOTOLASE. |
| Split-face group 2 | Experimental | Device: PHOTOLASE, Device: KTPIn group 2 the right side of the face will be treated with KTP and left side with PHOTOLASE. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- pregnancy
- lactation
- hemophilic condition
- Fitzpatrick skin phototype V-VI
- drug or alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PHOTOLASEAlso: yellow laserThis is the investigational yellow laser (PHOTOLASE) | Device | Split-face group 1, Split-face group 2 |
| KTPAlso: green laserThis is the traditional green laser (KTP) | Device | Split-face group 1, Split-face group 2 |
Primary outcome
TGS change
Time frame: Before treatment and 1-2 months after the intervention.
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.
2 secondary outcomes
VAS pain measurement
Time frame: Immediately after intervention.
Amount of treatment-related adverse effects using a 4-point scale.
Time frame: Immediately after treatment and 2-3 days after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mircea Guina, Prof study director
Tampere University of Technology, ORC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PHOTOLASE and KTP in people with Telangiectasia and Rosacea, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TGS change (time frame: Before treatment and 1-2 months after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2018.