NCT02700204

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 7, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 2, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

February 28, 2016

Last Update Submit

September 1, 2016

Conditions

Dyschromia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Histological evidence of LIOBs and location of LIOBs

    day 0 and at 48 hours

  • Observation of erythema/edema after treatment

    day 0 up to 2 months

  • Histological evidence of an inflammatory response

    at 48 hours

  • Histological evidence of new collagen growth

    at 2 months

  • Number of subjects with adverse events

    day 0, up to 7 months

Study Arms (2)

PicoWay 532nm fractional treatment

EXPERIMENTAL

subjects will receive one treatment for peri auricular and/or Buttocks by 532nm hand-piece

Device: PicoWay 532nm fractional treatment

PicoWay 1064nm fractional treatment

EXPERIMENTAL

subjects will receive one treatment for peri auricular and/or Buttocks by 1064nm hand-piece

Device: PicoWay 1064nm fractional treatment

Interventions

PicoWay 532nm fractional treatmentDEVICE

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

Also known as: PicoWay Resolve 532nm handpiece
PicoWay 532nm fractional treatment
PicoWay 1064nm fractional treatmentDEVICE

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

Also known as: PicoWay Resolve 1064nm handpiece
PicoWay 1064nm fractional treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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 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
  • 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)
  • 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 for patient who will treat peri-auricular 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arielle N. Kauvar,

New York, New York, 10028, United States

Location

Related Publications (1)

  • 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.

    PMID: 19916261BACKGROUND

Study Officials

  • Arielle Kauvar, MD

    NY Laser Skin Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2016

First Posted

March 7, 2016

Study Start

September 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 2, 2016

Record last verified: 2016-09

Locations

US(1)