Histological Study to Evaluate Skin Changes After PicoWay® 1064 nm and 532nm Picosecond Fractional Laser Treatment

This is an open-label, two-arm, histological evaluation study.

Subjects in this study will be assigned to Arm 1 or Arm 2, taking into account skin type, to receive PicoWay fractional treatment:

Arm 1: 532nm hand-piece Arm 2: 1064nm hand-piece Subjects will receive one treatment for peri auricular and/or Buttocks according the Investigator decision, with the fractional hand-piece

All subjects will have biopsies from the treated area:

• at baseline prior to treatment;
• immediately after treatment (within 30 minutes) or 48 hours after treatment;
• 2 months after treatment. Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.

Study Overview

• Status: Completed
• Conditions: Dyschromia
• Intervention / Treatment: Device: PicoWay 532nm fractional treatment; Device: PicoWay 1064nm fractional treatment

Detailed Description

This histological study is a prospective clinical study to evaluate skin biopsies after a single PicoWay treatment with the 532nm or 1064nm fractional hand-piece.

Up to 30 healthy candidates, will be enrolled at up to 2 participating study sites. Subjects in this study will be assigned to Arm 1 or Arm 2, taking into account skin type, to receive fractional treatment for peri auricular and/or Buttocks according to investigator decision:

Arm 1: 532nm hand-piece Arm 2: 1064nm hand-piece

Subjects will receive one treatment for peri auricular and/or Buttocks, with the fractional hand-piece. The investigator may use a multiplicity of energy levels in area or subarea in a single treatment, in order to titrate the optimum energy level. Further, if the investigator elects to, the Picoway handpiece can have at its distal end (at the distance gauge ending) a flat piece of a transparent plastic/glass (with appropriate anti reflective coating if desired), which will be in contact with the skin. In this case, the investigator may also elect to use a coupling gel as a matching medium between the skin and the glass.

All subjects will have biopsies of the treated area (a single or two peri or post-auricular, buttocks) at baseline prior to treatment. Biopsies from each area will also be performed immediately after treatment (within 30 minutes) and/or at ~48 hours after treatment, according to physician discretion, and at the 2-month follow-up.

Topical anesthetic (ointment) or intradermal injected solution may be used prior to treatment

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10028
      • Arielle N. Kauvar,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 having blemished skin, where the blemishes are of the type that photo rejuvenation would be a potential treatment option, including dyschromia, acne scars, wrinkles, etc., and willing to undergo laser treatment and skin biopsies pre-treatment, immediately after treatment, and at the 2-month follow-up
4. Willing to receive the proposed PicoWay fractional treatments and comply with all study (protocol) requirements including consenting to a minimum of 5 biopsies: at least 1 biopsy pretreatment, at least 2 biopsies immediately after treatment (at least 1 from each side), or at least 2 biopsies at 48 hours after treatment (at least 1 from each side) and at least 2 biopsies at 2 months after treatment (at least 1 from each side)
5. Willing to have photographs and images taken of the treated areas to be used in evaluations, publications and presentations (subject identity will be masked)
6. 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)
7. 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 for patient who will treat peri-auricular 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PicoWay 532nm fractional treatment; subjects will receive one treatment for peri auricular and/or Buttocks by 532nm hand-piece	Device: PicoWay 532nm fractional treatment; is a solid state laser capable of delivering energy at dual wavelength of 1064 nm or 532 nm at extremely short durations in the range of 300-900 ps; Other Names: PicoWay Resolve 532nm handpiece
Experimental: PicoWay 1064nm fractional treatment; subjects will receive one treatment for peri auricular and/or Buttocks by 1064nm hand-piece	Device: PicoWay 1064nm fractional treatment; is a solid state laser capable of delivering energy at dual wavelength of 1064 nm or 532 nm at extremely short durations in the range of 300-900 ps; Other Names: PicoWay Resolve 1064nm handpiece

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To collect skin biopsies after fractional PicoWay treatments	To collect skin biopsies after fractional PicoWay treatments to evaluate depth and damage caused by laser induced optical breakdown (LIOB)	day 0 up to 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histological evidence of LIOBs and location of LIOBs	Histological evidence of LIOBs and location of LIOBs (epidermis or dermis) immediately after treatment or at 48 hours after treatment, with either the 1064nm or 532nm picosecond fractional laser focused at the surface or sub-surface of the peri auricular and/or Buttocks area/s	day 0 and at 48 hours
Observation of erythema/edema after treatment	Observation of erythema/edema after treatment via clinical skin assessment	day 0 up to 2 months
Histological evidence of an inflammatory response	Histological evidence of an inflammatory response in the dermis immediately after treatment or at 48 hours after treatment that should lead to production of new collagen and elastin	at 48 hours
Histological evidence of new collagen growth	Histological evidence of new collagen growth at 2 months after treatment with either a 1064nm or 532nm picosecond fractional laser treatment	at 2 months
Number of subjects with adverse events	The number, description, severity, intervention and outcome of any adverse events will be reported on adverse event forms	day 0, up to 7 months

Collaborators and Investigators

• Sponsor: Syneron Medical
• Investigators: Principal Investigator: Arielle Kauvar, MD, NY Laser Skin Care

Publications and helpful links

General Publications

• Brightman L, Goldman MP, Taub AF. Sublative rejuvenation: experience with a new fractional radiofrequency system for skin rejuvenation and repair. J Drugs Dermatol. 2009 Nov;8(11 Suppl):s9-13.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: February 28, 2016
• First Submitted That Met QC Criteria: March 1, 2016
• First Posted (Estimate): March 7, 2016

Study Record Updates

• Last Update Posted (Estimate): September 2, 2016
• Last Update Submitted That Met QC Criteria: September 1, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: DHF19921

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided