Performance of PicoWayTM Picosecond Fractional Laser for Acne Scars

Not Applicable

• Conditions: Acne Scars - Mixed Atrophic and Hypertrophic
• Interventions: Device: PicoWay device

• Registration Number: NCT02592993
• Lead Sponsor: Syneron Medical

Brief Summary

Open-label, prospective study. Up to 60 healthy adult volunteers seeking facial acne scars treatment, males or females of 18 to 75 years of age, from up to 3 investigational sites.

Detailed Description

Subjects in this study will receive up to six (6) treatments in 3-8 weeks interval, with the PicoWayTM device-fractional handpiece 532nm and/or 1064nm according to the study protocol. Subjects will be followed by phone 7 days post first treatment by study staff, and will return for two 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 Timeline

• Study Start: 2015-05-23
• Study First Submitted: 2015-10-28
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-10-30
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-23
• Primary Completion: 2017-06
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 53

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 acne scars and wishes to undergo laser treatments for improvement
4. Have bilateral moderate to severe facial acne scars
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PicoWay treatment to all subjects	PicoWay device	Subjects in this study will receive up to six (6) treatments in 3-8 weeks interval, with the PicoWay device-fractional handpiece 532nm and/or 1064nm according to the study protocol. Subjects will be followed by phone 7 days post first treatment by study staff, and will return for two follow-up (FU) visits at the clinic at: 6 weeks and 12 weeks following the last treatment.

Primary Outcome Measures

Name	Time	Method
Efficacy of the PicoWayTM treatment	from day 0 up to 13 months	assessed by blinded evaluators following 3 or 5 treatments, or at 12 weeks post final treatment.

Secondary Outcome Measures

Name	Time	Method
Safety of the PicoWayTM	from day 0 up to 13 months	assessed by study investigator during all study visits (treatments and follow-up).
efficacy of the PicoWayTM fractional treatment by the investigator	after 3 weeks up to 13 months	assessed by study investigator during all study visits (starting from the second treatment).
Evaluate investigator satisfaction post treatments	after 46 weeks and after 52 weeks	assessed by investigator satisfaction post treatments
subject satisfaction post treatments	after 46 weeks and after 52 weeks	assessed by subject satisfaction post treatments.

Trial Locations

Locations (3)

Dr. Jerome M. Garden; 🇺🇸 Chicago, Illinois, United States

Dr. Eric F. Bernstein; 🇺🇸 Ardmore, Pennsylvania, United States

New York Laser & Skin Care; 🇺🇸 New York, New York, United States