Post Market Clinical Follow Up Study to Collect Additional Data and Imaging

NCT ID: NCT04881058

Last Updated: 2023-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-27
• Study Completion Date: 2022-03-11

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.

Detailed Description

Up to 10 subjects will be enrolled at 1 study center. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 4 treatments on the face with the PicoSure device.

Conditions

Pigmentation; Wrinkle

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PicoSure Device

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

Group Type: EXPERIMENTAL

RF Non-Invasive Treatment

Intervention Type: DEVICE

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

Interventions

RF Non-Invasive Treatment

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cynosure, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Civiok

Role: STUDY_DIRECTOR

Cynosure, Inc.

Locations

New Jersey Plastic Surgery

Montclair, New Jersey, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 31896400 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

7012-BDPM-2021

Identifier Type: -

Identifier Source: org_study_id