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Post Market Usability Evaluation Of The PicoSure Pro Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05102617
Recruitment Status : Active, not recruiting
First Posted : November 1, 2021
Last Update Posted : September 10, 2022
Sponsor:
Information provided by (Responsible Party):
Cynosure, Inc.

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.

Condition or disease Intervention/treatment Phase
Wrinkle Acne Scars Benign Epidermal Pigmented Lesions Benign Dermal Pigmented Lesions Tattoo Removal Device: PicoSure Pro Device Device: PicoSure Device Drug: Topical Cosmeceuticals Not Applicable

Detailed Description:
Subjects are to be enrolled in this clinical study if they are a healthy male or female 18 years of age or older. Up to 100 subjects will be enrolled at up to 4 study centers. Subjects will be enrolled into one of the 3 groups; Group A, Group B, or Group C.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: 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).
Primary Purpose: Treatment
Official Title: Post Market Usability Evaluation Of The PicoSure Pro Device
Actual Study Start Date : October 21, 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Arm Intervention/treatment
Experimental: Group A: Split-Face Device Only Treatment
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
This device will be used for up to 4 treatments over the designated areas.

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

Experimental: Group B: Split-Face Treatment with Cosmeceuticals
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
This device will be used for up to 4 treatments over the designated areas.

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

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

Experimental: Group C: Device Only Treatment
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
This device will be used for up to 4 treatments over the designated areas.

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




Primary Outcome Measures :
  1. Grading of Pre-Treatment vs. Follow Up Images [ Time Frame: 30 day follow up ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Is taking medications that alter the wound-healing response which may interfere with posttreatment healing and may require special precautions to be taken by a treating Investigator.
  • Is known to have a history of healing problems or history of keloid formation, Investigator discretion is required to determine the feasibility of treatment administration.
  • Has a history of skin cancer or suspicious lesions, Investigator discretion is required to determine feasibility of treatment administration.
  • Has had a chemical or mechanical epilation within the last six weeks may interfere with the post treatment healing process; Investigator discretion is required to determine feasibility of treatment administration.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05102617


Locations
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United States, California
Center for Dermatology and Laser Surgery
Sacramento, California, United States, 95819
United States, Massachusetts
Cynosure, Inc.
Westford, Massachusetts, United States, 01886
Sponsors and Collaborators
Cynosure, Inc.
Investigators
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Study Director: Jennifer Civiok Director of Clinical Research
Principal Investigator: Sean Doherty Cynosure, Inc.
Principal Investigator: Emil Tanghetti Center for Dermatology and Laser Surgery
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Responsible Party: Cynosure, Inc.
ClinicalTrials.gov Identifier: NCT05102617    
Other Study ID Numbers: 7051-PM01-2021
First Posted: November 1, 2021    Key Record Dates
Last Update Posted: September 10, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes