Port Wine StainsNCT01101360
Port Wine Stains Treatment Matrix RF Study
A study testing Matrix RF, Matrix RF followed by Pulse Dye Laser and Pulse Dye Laser followed by Matrix RF in people with Port Wine Stains, run by Syneron Medical at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of the Matrix RF for Port Wine Stains based on clinical and histological analyses. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Port Wine Stains
- What is being tested?
- Matrix RF, Matrix RF followed by Pulse Dye Laser and Pulse Dye Laser followed by Matrix RF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Sep 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent agreement signed by the subject.
- Healthy males or females older than 18 to 65 years of age.
- Having a low to mid depth Port Wine Stain of at least 5 cm2.
- Willingness to follow the treatment and follow-up schedule and the post-treatment care.
- For female candidates - post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).
Who cannot join
- PWS on lower legs or hands.
- Pregnant and/or breastfeeding.
- Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
- Having a permanent implant in the treated area, such as an injected chemical substance in the face (if treated).
- Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
- Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after each treatment session.
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- Use of retinoids, antioxidants or medical grade of skin nourishing supplements within 2 months of treatment or during the study.
- Having received a facial dermabrasion or chemical peel treatment within 3 months of treatment or during the study (if face is treated).
- Having received treatment with light, RF or other devices in the treated area within 6 months of treatment or during the study.
- Having received Botox/collagen/fat injections or other methods of augmentation with injected or implanted material in the treated area within 9 months of treatment or during the study (if face is treated).
- Having undergone a resurfacing procedure, face lift or eyelid surgery within a year of treatment or during the study (if face is treated).
- Having undergone any other surgery in the treated area within 6 months of treatment (or more if skin has not healed completely) or during the study.
- History of keloid scarring or of abnormal wound healing.
- Suffering from current or history of significant skin conditions in the treated area or inflammatory skin conditions, including, but not limited to: active acne, excessive skin dryness, psoriasis, eczema, rash, rosacea (particularly severe open wound stage), varicella scars, open lacerations or abrasions and active cold sores or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course.
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
- History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).
- History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
- Suffering from hormonal imbalance, as per the Investigator's discretion.
- Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician discretion).
- Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including actinic keratosis, presence of malignant or pre-malignant pigmented lesions.
- Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), or pertinent neurological disorders.
- Tattoo or permanent make-up in the treated area.
- Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
- Participation in a study of another device or drug within three month prior to enrollment or during the study.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Laser and Skin Surgery Center of New York
New York, New York, 10016
About this study
Official title: Evaluation of Fractional Radiofrequency (Matrix RF) Stand Alone and Combined With PDL Treatment on Port Wine Stains
The purpose of this study is to evaluate the efficacy and safety of the Matrix RF for Port Wine Stains based on clinical and histological analyses.
- Conditions
- Port Wine Stains
- Being tested
- Matrix RF, Matrix RF followed by Pulse Dye Laser, Pulse Dye Laser followed by Matrix RF
- Keywords
- port wine stains, radiofrequency, Pulse Dye Laser
- Medical subject headings
- Hemangioma, Capillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matrix RFDevice
Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week)
Matrix RF followed by Pulse Dye LaserDevice
Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week)
Pulse Dye Laser followed by Matrix RFDevice
Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week)
| Study group | Role | What they receive |
|---|---|---|
| Matrix RF followed by Pulse Dye Laser | Active comparator | Not described Receives: Device: Matrix RF; Device: Matrix RF followed by Pulse Dye Laser; Device: Pulse Dye Laser followed by Matrix RF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete healing
Assess safety of the Matrix RF treatment for port wine stains
Measured: Up to 30 weeks
Adverse events recording and monitoring
Measured: Up to 40 weeks
Secondary outcomes (4)
Clearance of port wine stain
Measured: Up to 40 weeks
Lightening of the port wine stain
Evaluation of lightening of the port wine stain will be made with reflectance spectrophotometer at all treatments and at 6 and 12 weeks following the last treatment.
Measured: Up to 40 weeks
Improvement of port wine stain
Assessment to be done by the subject via subject questionnaire during these visits
Measured: Up to 30 weeks
Reduction in blood vessel concentration
Biopsies taken from consenting subjects at one of the time points will be analyzed
Measured: Up to 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Port Wine StainsStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101360
- Sponsor's protocol ID
- DC75761
- Status last verified
- Nov 2014
- First submitted
- 7 Apr 2010
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fractional Radiofrequency (Matrix RF) Stand Alone and Combined With PDL Treatment on Port Wine Stains
- ClinicalTrials.gov ID
- NCT01101360
- Acronym / sponsor ID
- DC75761
- Conditions
- Port Wine Stains
- Keywords
- port wine stains, radiofrequency, Pulse Dye Laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Sep 2011 (actual)
- First posted
- 9 Apr 2010 (estimated)
- 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 evaluate the efficacy and safety of the Matrix RF for Port Wine Stains based on clinical and histological analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Matrix RF followed by Pulse Dye Laser | Active comparator | Device: Matrix RF, Device: Matrix RF followed by Pulse Dye Laser, Device: Pulse Dye Laser followed by Matrix RF |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent agreement signed by the subject.
- Healthy males or females older than 18 to 65 years of age.
- Having a low to mid depth Port Wine Stain of at least 5 cm2.
- Willingness to follow the treatment and follow-up schedule and the post-treatment care.
- For female candidates - post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).
Key exclusion criteria (25 listed)
- PWS on lower legs or hands.
- Pregnant and/or breastfeeding.
- Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
- Having a permanent implant in the treated area, such as an injected chemical substance in the face (if treated).
- Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
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 |
|---|---|---|
| Matrix RFSection of port wine stain to be treated 5 times every 5 weeks (+/- 1 week) | Device | Matrix RF followed by Pulse Dye Laser |
| Matrix RF followed by Pulse Dye LaserSection of port wine stain to be treated 5 times every 5 weeks (+/- 1 week) | Device | Matrix RF followed by Pulse Dye Laser |
| Pulse Dye Laser followed by Matrix RFSection of port wine stain to be treated 5 times every 5 weeks (+/- 1 week) | Device | Matrix RF followed by Pulse Dye Laser |
Primary outcome
Time to complete healing
Time frame: Up to 30 weeks
Assess safety of the Matrix RF treatment for port wine stains
Adverse events recording and monitoring
Time frame: Up to 40 weeks
4 secondary outcomes
Clearance of port wine stain
Time frame: Up to 40 weeks
Lightening of the port wine stain
Time frame: Up to 40 weeks
Improvement of port wine stain
Time frame: Up to 30 weeks
Reduction in blood vessel concentration
Time frame: Up to 40 weeks
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 2 Dec 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Matrix RF, Matrix RF followed by Pulse Dye Laser and Pulse Dye Laser followed by Matrix RF in people with Port Wine Stains, run by Syneron Medical at 1 site in United States.
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 25 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 2 Dec 2014. 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 United States. 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?
Time to complete healing (time frame: Up to 30 weeks). The study lists 2 primary outcomes in all. 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 2 Dec 2014.