Unwanted WrinklesNCT02600104
Evaluate the Performance of the PicoWayTM Picosecond Fractional Laser for Wrinkles Reduction
A study testing PicoWayTM in people with Unwanted Wrinkles, run by Syneron Medical at 4 sites in United States.
Trial summary
Prospective clinical study, Up to 100 healthy adult volunteers seeking Treatment of Wrinkles Reduction in the facial area, males or females of 18 to 75 years of age, from up to 5 investigational sites. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Unwanted Wrinkles
- What is being tested?
- PicoWayTM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 4 sitesUnited States
- Study dates
- 10 Jun 2015to 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female and male subjects between 18 to 75 years of age
- Has Fitzpatrick skin type I-VI
- Subjects seeking treatment for wrinkles reduction and willing to undergo laser treatments for improvement
- Have mild to moderate bilateral perioral and/or periorbital wrinkles
- Willing to receive the proposed PicoWayTM fractional treatments and comply with all study (protocol) requirements
- Willing to have photographs and images taken of the treated areas to be used in evaluations, publications and presentations (subject identity will be masked)
- For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence)
- Informed consent process is completed and subject consent is signed
Who cannot join
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding
- Hypersensitivity to light exposure
- Active sun tan in facial area
- Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course
- Is taking medication(s) for which sunlight is a contraindication
- Has a history of squamous cell carcinoma or melanoma
Show all 14Show fewer
- History of keloid scarring, abnormal wound healing and / or prone to bruising
- History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders
- Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment, e.g., lack of noticeable skin flaking, skin peeling and skin surface roughness.
- A laser procedure, a peel or has used lightening creams that was performed in the area to be treated with the past six months
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications
- Known allergy to lidocaine, tetracaine, Xylocaine or epinephrine
- Subjects with pigmented lesions that are considered not acceptable by the study investigator or any condition that, in the investigator's opinion, would make it unsafe to treat.
- 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
4 sites in 1 country.
United States4 sites
Eric F. Bernstein
Ardmore, Pennsylvania, 19003
Jerome M. Garden
Chicago, Illinois, 60611
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Arielle N. Kauvar
New York, New York, 10028
About this study
Official title: Clinical Study to Evaluate the Performance of the PicoWayTM Picosecond Fractional Laser for Wrinkles Reduction
Prospective clinical study, Up to 100 healthy adult volunteers seeking Treatment of Wrinkles Reduction in the facial area, males or females of 18 to 75 years of age, from up to 5 investigational sites.
Read the detailed description
This is an open-label, multi-center study. Subjects in this study will receive up to four (4) facial treatments in 3-8 weeks interval, with the PicoWayTM device-fractional hand piece 1064nm and/or 532nm according to the study protocol. Subjects will be followed by phone 7 days post first treatment by study staff, and will return for follow-up (FU) visits at the clinic at: 6 weeks and 12 weeks following the last treatment.
Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.
- Conditions
- Unwanted Wrinkles
- Being tested
- PicoWayTM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PicoWayTMDevice
The PicoWayTM base unit using a single, free-running, flashlamp-pumped alexandrite laser as a pump source for both the oscillator and the amplifier
| Study group | Role | What they receive |
|---|---|---|
| all subjects | Experimental | will receive up to four (4) facial treatments in 3-8 weeks interval, with the PicoWayTM device-fractional hand piece 1064nm and/or 532nm according to the study protocol. Subjects will be followed by phone 7 days post first treatment by study staff, and will return for follow-up (FU) visits at the clinic at: 6 weeks and 12 weeks following the last treatment. Receives: Device: PicoWayTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of PicoWay for facial wrinkles reduction treatment assessed by blinded evaluators based on Fitzpatrick Classification and Degree of Elastosis.
assessed by blinded evaluators.
Measured: day 0 up to 9 months
Secondary outcomes (4)
Improvement in Fitzpatrick Classification and Degree of Elastosis, as assessed by study investigator
Percentage of subjects with improvement in Fitzpatrick Classification and Degree of Elastosis, as assessed by study investigator
Measured: from 3 weeks up to 9 months
Safety of PicoWay treatment by Adverse events record during all study
assessed by study investigator during all study
Measured: day 0 up to 9 months
Evaluate investigator satisfaction assessed by questionnaire
by questionnaire
Measured: from 24 weeks up to 36 weeks
Evaluate subject satisfaction assessed by questionnaire
by questionnaire
Measured: from 24 weeks up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study start10 Jun 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unwanted WrinklesStudies 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric F Bernstein, M.D., Principal investigator, Main Line Center for Laser Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600104
- Sponsor's protocol ID
- DHF17271
- Status last verified
- Apr 2017
- First submitted
- 28 Oct 2015
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Bloom BS, Emer J, Goldberg DJ. Assessment of safety and efficacy of a bipolar fractionated radiofrequency device in the treatment of photodamaged skin. J Cosmet Laser Ther. 2012 Oct;14(5):208-11. doi: 10.3109/14764172.2012.724534.
PubMed 23016529
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Performance of the PicoWayTM Picosecond Fractional Laser for Wrinkles Reduction
- ClinicalTrials.gov ID
- NCT02600104
- Acronym / sponsor ID
- DHF17271
- Conditions
- Unwanted Wrinkles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2015 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 9 Nov 2015 (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.
Prospective clinical study, Up to 100 healthy adult volunteers seeking Treatment of Wrinkles Reduction in the facial area, males or females of 18 to 75 years of age, from up to 5 investigational sites.
Detailed description
This is an open-label, multi-center study. Subjects in this study will receive up to four (4) facial treatments in 3-8 weeks interval, with the PicoWayTM device-fractional hand piece 1064nm and/or 532nm according to the study protocol. Subjects will be followed by phone 7 days post first treatment by study staff, and will return for follow-up (FU) visits at the clinic at: 6 weeks and 12 weeks following the last treatment.
Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all subjects | Experimental | Device: PicoWayTMwill receive up to four (4) facial treatments in 3-8 weeks interval, with the PicoWayTM device-fractional hand piece 1064nm and/or 532nm according to the study protocol. Subjects will be followed by phone 7 days post first treatment by study staff, and will return for follow-up (FU) visits at the clinic at: 6 weeks and 12 weeks following the last treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy female and male subjects between 18 to 75 years of age
- Has Fitzpatrick skin type I-VI
- Subjects seeking treatment for wrinkles reduction and willing to undergo laser treatments for improvement
- Have mild to moderate bilateral perioral and/or periorbital wrinkles
- Willing to receive the proposed PicoWayTM fractional treatments and comply with all study (protocol) requirements
Key exclusion criteria (14 listed)
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding
- Hypersensitivity to light exposure
- Active sun tan in facial area
- Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course
- Is taking medication(s) for which sunlight is a contraindication
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 |
|---|---|---|
| PicoWayTMThe PicoWayTM base unit using a single, free-running, flashlamp-pumped alexandrite laser as a pump source for both the oscillator and the amplifier | Device | all subjects |
Primary outcome
Efficacy of PicoWay for facial wrinkles reduction treatment assessed by blinded evaluators based on Fitzpatrick Classification and Degree of Elastosis.
Time frame: day 0 up to 9 months
assessed by blinded evaluators.
4 secondary outcomes
Improvement in Fitzpatrick Classification and Degree of Elastosis, as assessed by study investigator
Time frame: from 3 weeks up to 9 months
Safety of PicoWay treatment by Adverse events record during all study
Time frame: day 0 up to 9 months
Evaluate investigator satisfaction assessed by questionnaire
Time frame: from 24 weeks up to 36 weeks
Evaluate subject satisfaction assessed by questionnaire
Time frame: from 24 weeks up to 36 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Background: PubMed 23016529Bloom BS, Emer J, Goldberg DJ. Assessment of safety and efficacy of a bipolar fractionated radiofrequency device in the treatment of photodamaged skin. J Cosmet Laser Ther. 2012 Oct;14(5):208-11. doi: 10.3109/14764172.2012.724534.
- Individual participant dataSharing planned: Undecided
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 F Bernstein, M.D. principal investigator
Main Line Center for Laser Surgery
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PicoWayTM in people with Unwanted Wrinkles, run by Syneron Medical at 4 sites 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 8 inclusion and 14 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 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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?
Efficacy of PicoWay for facial wrinkles reduction treatment assessed by blinded evaluators based on Fitzpatrick Classification and Degree of Elastosis. (time frame: day 0 up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02600104, which also lists 1 linked publication.
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 4 Apr 2017.