Performance of PicoWayTM Picosecond Fractional Laser for Acne Scars

NCT02592993 | Unknown

• 1 other identifier: DHF17261
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 3

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.

Conditions

Acne Scars - Mixed Atrophic and Hypertrophic

Outcome Measures

Primary Outcomes (1)

• Efficacy of the PicoWayTM treatment

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

  from day 0 up to 13 months

Secondary Outcomes (4)

• Safety of the PicoWayTM

  from day 0 up to 13 months

• efficacy of the PicoWayTM fractional treatment by the investigator

  after 3 weeks up to 13 months

• Evaluate investigator satisfaction post treatments

  after 46 weeks and after 52 weeks

• subject satisfaction post treatments

  after 46 weeks and after 52 weeks

Study Arms (1)

PicoWay treatment to all subjects

EXPERIMENTAL

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.

Device: PicoWay device

Interventions

PicoWay device DEVICE

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

PicoWay treatment to all subjects

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Syneron Medical: lead

Study Sites (3)

Dr. Jerome M. Garden

Chicago, Illinois, 60611, United States

Location

New York Laser & Skin Care

New York, New York, 10028, United States

Location

Dr. Eric F. Bernstein

Ardmore, Pennsylvania, 19003, United States

Location

Related Publications (1)

• 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.

  PMID: 26493925 BACKGROUND

MeSH Terms

Conditions

Hypertrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: October 30, 2015
• Study Start: May 23, 2015
• Primary Completion: June 1, 2017
• Study Completion: August 1, 2017
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

US (3)