CClinicalTrials.gg
Status unknownNCT02600104Updated Apr 4, 2017

Evaluate the Performance of the PicoWayTM Picosecond Fractional Laser for Wrinkles Reduction

An interventional study of PicoWayTM in Unwanted Wrinkles, sponsored by Syneron Medical. Status unknown at 4 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-04.

Sponsored by Syneron Medical · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2017), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jun 2015, registered Oct 2015).
Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Unwanted Wrinkles
03

In context

Lead sponsor

Syneron Medical is the lead sponsor of 41 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy female and male subjects between 18 to 75 years of age
  2. Has Fitzpatrick skin type I-VI
  3. Subjects seeking treatment for wrinkles reduction and willing to undergo laser treatments for improvement
  4. Have mild to moderate bilateral perioral and/or periorbital wrinkles
  5. Willing to receive the proposed PicoWayTM fractional treatments and comply with all study (protocol) requirements
  6. Willing to have photographs and images taken of the treated areas to be used in evaluations, publications and presentations (subject identity will be masked)
  7. 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)
  8. Informed consent process is completed and subject consent is signed

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding
  2. Hypersensitivity to light exposure
  3. Active sun tan in facial area
  4. 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
  5. Is taking medication(s) for which sunlight is a contraindication
  6. Has a history of squamous cell carcinoma or melanoma
  7. History of keloid scarring, abnormal wound healing and / or prone to bruising
  8. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders
  9. 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.
  10. A laser procedure, a peel or has used lightening creams that was performed in the area to be treated with the past six months
  11. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications
  12. Known allergy to lidocaine, tetracaine, Xylocaine or epinephrine
  13. 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.
  14. As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
74 participants (actual)

Study arms

  • Experimental
    all subjects

    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.

    Device: PicoWayTM

Interventions

  • DevicePicoWayTM

    The PicoWayTM base unit using a single, free-running, flashlamp-pumped alexandrite laser as a pump source for both the oscillator and the amplifier

06

What researchers measure

Primary outcomes

  1. Efficacy of PicoWay for facial wrinkles reduction treatment assessed by blinded evaluators based on Fitzpatrick Classification and Degree of Elastosis.

    assessed by blinded evaluators.

    Time frame: day 0 up to 9 months

Secondary outcomes

  1. 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

    Time frame: from 3 weeks up to 9 months

  2. Safety of PicoWay treatment by Adverse events record during all study

    assessed by study investigator during all study

    Time frame: day 0 up to 9 months

  3. Evaluate investigator satisfaction assessed by questionnaire

    by questionnaire

    Time frame: from 24 weeks up to 36 weeks

  4. Evaluate subject satisfaction assessed by questionnaire

    by questionnaire

    Time frame: from 24 weeks up to 36 weeks

07

Study locations

4 sites
  • Jerome M. Garden
    Chicago, Illinois 60611, United States
  • Arielle N. Kauvar
    New York, New York 10028, United States
  • Eric F. Bernstein
    Ardmore, Pennsylvania 19003, United States
  • Tennessee Clinical Research Center
    Nashville, Tennessee 37215, United States
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02600104
Lead sponsor
Syneron Medical
Responsible party
Sponsor
First posted
Nov 9, 2015
Start date
Jun 10, 2015
Primary completion
Dec 2017 (estimated)
Completion
Dec 2018 (estimated)
Last update
Apr 4, 2017

Study contacts

Eric F Bernstein, M.D.
principal investigator · Main Line Center for Laser Surgery

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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