EVALUATION OF THE EFFECT OF THE PERFECTA V-BEAM LASER ON ROSACEA (NCT03211585) | Clinical Trial Compass
UnknownNot Applicable
EVALUATION OF THE EFFECT OF THE PERFECTA V-BEAM LASER ON ROSACEA
20 participantsStarted 2016-10
Plain-language 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. 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The percentage reduction in the facial redness and telangiectasias of rosacea
Timeframe: two months following the final treatment