NCT04881058

Brief Summary

The intended use of the PicoSure device with focus lens array used in this study is to assess images to support additional marketing claims for the treatment of pigmentation and mild to moderate wrinkles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

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

April 27, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 11, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2022

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 27, 2023

Completed
Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

11 months

First QC Date

May 3, 2021

Results QC Date

April 24, 2023

Last Update Submit

June 2, 2023

Conditions

PigmentationWrinkle

Outcome Measures

Primary Outcomes (1)

  • Correct Identification of Baseline Photographs vs. Photographs Taken 3 Months Post Last Treatment

    Three blinded independent reviewers will perform a photographic evaluation in which they will be asked to identify pre-treatment images when compared to post treatment images. The percentage of photographs that were correctly identified as either baseline photographs or photographs taken at the 3 month follow up will be reported. Identifying whether the photograph was taken at the baseline vs. 3 month follow up was only done at the 3 month follow up point.

    3 month follow up

Study Arms (1)

PicoSure Device

EXPERIMENTAL

The PicoSure device will be used on the face for the treatment of pigmentation and mild to moderate wrinkles.

Device: RF Non-Invasive Treatment

Interventions

RF Non-Invasive TreatmentDEVICE

Self-controlled single-arm group using the PicoSure device.

PicoSure Device

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A healthy male or female 18 - 65 years of age.
  • Willing to undergo treatments for pigmentation and/or mild to moderate wrinkles on the face with the PicoSure device.
  • Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
  • Understands and accepts the obligation and is logistically able to be present for all visits.
  • Is willing to comply with all requirements of the study and sign the informed consent document.

You may not qualify if:

  • Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
  • The subject is hypersensitive to light in the near infrared wavelength region.
  • The subject takes medication which is known to increase sensitivity to sunlight.
  • The subject has seizure disorders triggered by light.
  • The subject takes or has taken oral isotretinoin, such as Accutane®, within the last six months.
  • The subject has an active localized or systemic infection, or an open wound in area being treated.
  • The subject has a significant systemic illness, such as lupus, or an illness localized in area being treated.
  • The subject has common acquired nevi that are predisposed to the development of malignant melanoma.
  • The subject has herpes simplex in the area being treated.
  • The subject is receiving or has received gold therapy.
  • The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months to entering this study.
  • The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Jersey Plastic Surgery

Montclair, New Jersey, 07042, United States

Location

Related Publications (1)

  • Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.

    PMID: 31896400RESULT

Results Point of Contact

Title
Jamie Trimper
Organization
Cynosure
jamie.trimper@cynosure.com
(978) 256-4200

Study Officials

  • Jennifer Civiok

    Cynosure, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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

May 3, 2021

First Posted

May 11, 2021

Study Start

April 27, 2021

Primary Completion

March 11, 2022

Study Completion

March 11, 2022

Last Updated

June 27, 2023

Results First Posted

June 27, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)