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Performance of PicoWayTM Picosecond Fractional Laser for Acne Scars

Primary Purpose

Acne Scars - Mixed Atrophic and Hypertrophic

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PicoWay device

About this trial

This is an interventional treatment trial for Acne Scars - Mixed Atrophic and Hypertrophic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy female and male subjects between 18 to 75 years of age
Has Fitzpatrick skin type I-VI
Subjects seeking treatment for acne scars and wishes to undergo laser treatments for improvement
Have bilateral moderate to severe facial acne scars
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

Exclusion Criteria:

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
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

Sites / Locations

Dr. Jerome M. Garden
New York Laser & Skin Care
Dr. Eric F. Bernstein

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PicoWay treatment to all subjects

Arm Description

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.

Outcomes

Primary Outcome Measures

Efficacy of the PicoWayTM treatment

assessed by blinded evaluators following 3 or 5 treatments, or at 12 weeks post final treatment.

Secondary Outcome Measures

Safety of the PicoWayTM

assessed by study investigator during all study visits (treatments and follow-up).

efficacy of the PicoWayTM fractional treatment by the investigator

assessed by study investigator during all study visits (starting from the second treatment).

Evaluate investigator satisfaction post treatments

assessed by investigator satisfaction post treatments

subject satisfaction post treatments

assessed by subject satisfaction post treatments.

Full Information

NCT ID

NCT02592993

First Posted

October 28, 2015

Last Updated

February 22, 2017

Sponsor

Syneron Medical

1. Study Identification

Unique Protocol Identification Number

NCT02592993

Brief Title

Performance of PicoWayTM Picosecond Fractional Laser for Acne Scars

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Unknown status

Study Start Date

May 23, 2015 (Actual)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Syneron Medical

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Scars - Mixed Atrophic and Hypertrophic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PicoWay treatment to all subjects

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

PicoWay device

Intervention Description

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

Primary Outcome Measure Information:

Title

Efficacy of the PicoWayTM treatment

Description

assessed by blinded evaluators following 3 or 5 treatments, or at 12 weeks post final treatment.

Time Frame

from day 0 up to 13 months

Secondary Outcome Measure Information:

Title

Safety of the PicoWayTM

Description

assessed by study investigator during all study visits (treatments and follow-up).

Time Frame

from day 0 up to 13 months

Title

efficacy of the PicoWayTM fractional treatment by the investigator

Description

assessed by study investigator during all study visits (starting from the second treatment).

Time Frame

after 3 weeks up to 13 months

Title

Evaluate investigator satisfaction post treatments

Description

assessed by investigator satisfaction post treatments

Time Frame

after 46 weeks and after 52 weeks

Title

subject satisfaction post treatments

Description

assessed by subject satisfaction post treatments.

Time Frame

after 46 weeks and after 52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy female and male subjects between 18 to 75 years of age Has Fitzpatrick skin type I-VI Subjects seeking treatment for acne scars and wishes to undergo laser treatments for improvement Have bilateral moderate to severe facial acne scars 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 Exclusion Criteria: 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 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

Facility Information:

Facility Name

Dr. Jerome M. Garden

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

New York Laser & Skin Care

City

New York

State/Province

New York

ZIP/Postal Code

10028

Country

United States

Facility Name

Dr. Eric F. Bernstein

City

Ardmore

State/Province

Pennsylvania

ZIP/Postal Code

19003

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

26493925

Citation

Hoang Viet M, Derreumaux P, Li MS, Roland C, Sagui C, Nguyen PH. Picosecond dissociation of amyloid fibrils with infrared laser: A nonequilibrium simulation study. J Chem Phys. 2015 Oct 21;143(15):155101. doi: 10.1063/1.4933207.

Results Reference

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Performance of PicoWayTM Picosecond Fractional Laser for Acne Scars

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