RosaceaNCT03211585
EVALUATION OF THE EFFECT OF THE PERFECTA V-BEAM LASER ON ROSACEA
A study testing Perfecta V-Beam laser in people with Rosacea, run by Syneron Medical.
Trial summary
The purpose of this study is to further quantify the safety and effectiveness of the Syneron-Candela long pulse-duration, extended sub-pulse, larger spot-size prototype Perfecta V-Beam, 595nm laser system for the treatment of facial redness associated with flushing and blushing, or rosacea. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Rosacea
- What is being tested?
- Perfecta V-Beam laser
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Dec 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must have a Fitzpatrick skin type of I-IV and have Rosacea as evaluated by the treating physician.
- Subjects must have visible telangiectasia on the side of the face.
- Subjects must be willing and able to comply with all follow-up requirements.
- Subjects must be willing and able to apply sunblock SPF of 30 while exposed to the sun.
- Subject willing to have photographs taken and used in presentations or publications.
Who cannot join
- Subjects must not have had a previous laser treatment, deep chemical peel in the intended treatment site(s) within 6 months prior to treatment, oral retinoids within 6 months of their inclusion into this study or have ever taken gold therapy.
- Subjects must not have a history of keloid formation.
- Subjects with Fitzpatrick Classification of V or VI (to reduce the risk of hyper-pigmentation).
- Subjects must be willing and able to comply with all follow-up requirements.
- Subjects cannot have vitiligo, a condition where pigment is lost in the skin and white patches appear).
- Subjects not willing to avoid sun exposure or not will to apply sunblock SPF of 30 while exposed to the sun.
- Subject not willing to have photographs taken and used in presentations, publications and marketing material
About this study
Official title: EVALUATION OF THE EFFECT OF THE PERFECTA V-BEAM LASER ON ROSACEA (FACIAL REDNESS, TELANGIECTASIAS AND PHOTODAMAGE)
The purpose of this study is to further quantify the safety and effectiveness of the Syneron-Candela long pulse-duration, extended sub-pulse, larger spot-size prototype Perfecta V-Beam, 595nm laser system for the treatment of facial redness associated with flushing and blushing, or rosacea. The Perfecta laser system is expected to provide effective treatment of rosacea with less bruising or purpura and greater effectiveness than previous generation systems. This study should enable optimization of treatment parameters for using the Perfecta 595nm laser for treating rosacea.
- Conditions
- Rosacea
- Being tested
- Perfecta V-Beam laser
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perfecta V-Beam laserDevice
This s a single study and a prototype of the FDA-cleared, flashlamp-pumped pulsed-dye laser, that is currently on the market, that has evolved over almost 25 years of continuous development. The broad-spectrum flashlamp pumps energy into a cavity containing liquid dye. The dye is excited resulting in the emission of 595 nm orange light.
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage reduction in the facial redness and telangiectasias of rosacea
The percentage reduction in the facial redness and telangiectasias of rosacea will be determined by the investigators using polarized photography for each subject
Measured: two months following the final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study startOct 2016
- Primary completionApr 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RosaceaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Bernstein, MD, Principal investigator, Main Line Center for Laser Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211585
- Sponsor's protocol ID
- 2016-01
- Status last verified
- Jul 2017
- First submitted
- 5 Jul 2017
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE EFFECT OF THE PERFECTA V-BEAM LASER ON ROSACEA (FACIAL REDNESS, TELANGIECTASIAS AND PHOTODAMAGE)
- ClinicalTrials.gov ID
- NCT03211585
- Acronym / sponsor ID
- 2016-01
- Conditions
- Rosacea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 7 Jul 2017 (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 purpose of this study is to further quantify the safety and effectiveness of the Syneron-Candela long pulse-duration, extended sub-pulse, larger spot-size prototype Perfecta V-Beam, 595nm laser system for the treatment of facial redness associated with flushing and blushing, or rosacea. The Perfecta laser system is expected to provide effective treatment of rosacea with less bruising or purpura and greater effectiveness than previous generation systems. This study should enable optimization of treatment parameters for using the Perfecta 595nm laser for treating rosacea.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must have a Fitzpatrick skin type of I-IV and have Rosacea as evaluated by the treating physician.
- Subjects must have visible telangiectasia on the side of the face.
- Subjects must be willing and able to comply with all follow-up requirements.
- Subjects must be willing and able to apply sunblock SPF of 30 while exposed to the sun.
- Subject willing to have photographs taken and used in presentations or publications.
Key exclusion criteria (7 listed)
- Subjects must not have had a previous laser treatment, deep chemical peel in the intended treatment site(s) within 6 months prior to treatment, oral retinoids within 6 months of their inclusion into this study or have ever taken gold therapy.
- Subjects must not have a history of keloid formation.
- Subjects with Fitzpatrick Classification of V or VI (to reduce the risk of hyper-pigmentation).
- Subjects must be willing and able to comply with all follow-up requirements.
- Subjects cannot have vitiligo, a condition where pigment is lost in the skin and white patches appear).
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 |
|---|---|---|
| Perfecta V-Beam laserThis s a single study and a prototype of the FDA-cleared, flashlamp-pumped pulsed-dye laser, that is currently on the market, that has evolved over almost 25 years of continuous development. The broad-spectrum flashlamp pumps energy into a cavity containing liquid dye. The dye is excited resulting in the emission of 595 nm orange light. | Device | – |
Primary outcome
The percentage reduction in the facial redness and telangiectasias of rosacea
Time frame: two months following the final treatment
The percentage reduction in the facial redness and telangiectasias of rosacea will be determined by the investigators using polarized photography for each subject
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
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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.
Eric Bernstein, MD principal investigator
Main Line Center for Laser Surgery
Questions about this trial
What is this clinical trial studying?
A study testing Perfecta V-Beam laser in people with Rosacea, run by Syneron Medical.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
The percentage reduction in the facial redness and telangiectasias of rosacea (time frame: two months following the final treatment). 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 12 Jul 2017.