Loading clinical trials...

UNKNOWNNA

Performance of PicoWayTM Picosecond Fractional Laser for Acne Scars

Clinical Study to Evaluate the Performance of the PicoWayTM Picosecond Fractional Laser for Treatment of Acne Scars

NCT02592993•Syneron Medical

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.

Eligibility

Age

18 - 75 years

Sex

ALL

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 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
+4 more criteria

Locations (3)

Dr. Jerome M. Garden

Chicago, Illinois, United States

New York Laser & Skin Care

New York, New York, United States

Dr. Eric F. Bernstein

Ardmore, Pennsylvania, United States

Key Dates

Start Date

May 23, 2015

Primary Completion Date

June 1, 2017

Completion Date

August 1, 2017

Last Updated

February 23, 2017

Enrollment

ACTUAL participants

Conditions

Acne Scars - Mixed Atrophic and Hypertrophic

Interventions

PicoWay device

DEVICE

The MIRIA Acne Scar Study

NCT05597267

Acne Scars - Mixed Atrophic and Hypertrophic

View study

COMPLETEDNA

Clinical Evaluation of the Safety and Performance of FRF for the Treatment and Reduction of Acne Scarring

NCT04827680

Acne Scars - Mixed Atrophic and Hypertrophic

View study

COMPLETEDNA

Tripeptide/Hexapeptide Topical and Hybrid Laser Treatment for Acne Scarring

NCT04606134

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Performance of PicoWayTM Picosecond Fractional Laser for Acne Scars

Inclusion Criteria

Exclusion Criteria

The MIRIA Acne Scar Study

Clinical Evaluation of the Safety and Performance of FRF for the Treatment and Reduction of Acne Scarring

Tripeptide/Hexapeptide Topical and Hybrid Laser Treatment for Acne Scarring

Microneedling With Topical Preparations in the Treatment of Atrophic Post-acne Scars