Post Market Usability Evaluation Of The PicoSure Pro Device

NCT05102617 | Completed FDA Device

• 1 other identifier: 7051-PM01-2021
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

The intended use of the PicoSure and PicoSure Pro devices used in this study is to treat additional patients with the new PicoSure Pro device and collect additional data on the devices.

Conditions

Wrinkle; Acne Scars; Benign Epidermal Pigmented Lesions; Benign Dermal Pigmented Lesions; Tattoo Removal

Outcome Measures

Primary Outcomes (1)

• Grading of Pre-Treatment vs. Follow Up Images

  The investigator will grade the improvement they noticed between the baseline image and the follow up image based on the Global Aesthetic Improvement Scale (GAIS), which ranges from 1-5 as follows: Very Much Improved (1), Much Improved (2), Improved (3), No Change (4), Worse (5).

  30 day follow up

Study Arms (3)

Group A: Split-Face Device Only Treatment

EXPERIMENTAL

Subjects will receive a split face treatment with the PicoSure Pro and/or PicoSure devices using different device settings on each half of the face.

Device: PicoSure Pro Device; Device: PicoSure Device

Group B: Split-Face Treatment with Cosmeceuticals

EXPERIMENTAL

Subjects will receive a full face treatment with the PicoSure Pro or PicoSure device and will use topical cosmeceuticals on only half of their face.

Device: PicoSure Pro Device; Device: PicoSure Device; Drug: Topical Cosmeceuticals

Group C: Device Only Treatment

EXPERIMENTAL

Subjects will receive treatments with the PicoSure Pro or PicoSure device on multiple areas of the body such as the face, décolletage, back, legs, arms, and hands.

Device: PicoSure Pro Device; Device: PicoSure Device

Interventions

PicoSure Pro Device DEVICE

This device will be used for up to 4 treatments over the designated areas.

Group A: Split-Face Device Only Treatment; Group B: Split-Face Treatment with Cosmeceuticals; Group C: Device Only Treatment

PicoSure Device DEVICE

This device will be used for up to 4 treatments over the designated areas.

Group A: Split-Face Device Only Treatment; Group B: Split-Face Treatment with Cosmeceuticals; Group C: Device Only Treatment

Topical Cosmeceuticals DRUG

Topical cosmeceuticals, such as a hydrating serum or cream, will be applied on the designated area.

Group B: Split-Face Treatment with Cosmeceuticals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A healthy male or female 18 years of age or older.
• Willing to undergo treatments with the PicoSure and PicoPro devices for pigmentary lesions, acne scars, skin revitalization, or tattoo removal.
• 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 female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
• 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.
• Cautionary Criteria:
• Has unprotected sun exposure within four weeks of treatment, including the use of tanning beds or tanning products, such as creams, lotions and sprays may interfere with the laser treatment; Investigator discretion is required to determine feasibility of treatment administration.
• Has a coagulation disorder or is currently using anti-coagulation medications. Anticoagulants may cause excessive bleeding and interfere with posttreatment healing; Investigator discretion is required to determine feasibility of treatment administration for subjects taking anticoagulants.

Sponsors & Collaborators

• Cynosure, Inc.: lead

Study Sites (2)

Center for Dermatology and Laser Surgery

Sacramento, California, 95819, United States

Location

Cynosure, Inc.

Westford, Massachusetts, 01886, United States

Location

MeSH Terms

Interventions

Cosmeceuticals

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Cosmetics; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Jennifer Civiok

  Director of Clinical Research

  STUDY DIRECTOR

• Sean Doherty

  Cynosure, Inc.

  PRINCIPAL INVESTIGATOR

• Emil Tanghetti

  Center for Dermatology and Laser Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Randomization is not used for determining which arm subjects will participate in, however, it will be used to determine which side of the treatment area will receive which treatment regimen (if in a group receiving split-face treatments).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 1, 2021
• Study Start: October 21, 2021
• Primary Completion: March 15, 2023
• Study Completion: March 15, 2023
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)