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

NCT ID: NCT02600104

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-10
• Study Completion Date: 2018-12-31

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PicoWayTM

Intervention Type: DEVICE

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

Interventions

PicoWayTM

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

Intervention Type: DEVICE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Syneron Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric F Bernstein, M.D.

Role: PRINCIPAL_INVESTIGATOR

Main Line Center for Laser Surgery

Locations

Jerome M. Garden

Chicago, Illinois, United States

Arielle N. Kauvar

New York, New York, United States

Eric F. Bernstein

Ardmore, Pennsylvania, United States

Tennessee Clinical Research Center

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23016529 (View on PubMed)

Other Identifiers

DHF17271

Identifier Type: -

Identifier Source: org_study_id