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CompletedNCT05102617Updated Jan 9, 2024

Post Market Usability Evaluation Of The PicoSure Pro Device

An interventional study of PicoSure Pro Device and PicoSure Device in Wrinkle, Acne Scars and Benign Epidermal Pigmented Lesions, sponsored by Cynosure, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-09.

Sponsored by Cynosure, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Wrinkle
  • Acne Scars
  • Benign Epidermal Pigmented Lesions
  • Benign Dermal Pigmented Lesions
  • Tattoo Removal
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • 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 · Device: PicoSure Device

  • 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 · Device: PicoSure Device · Drug: Topical Cosmeceuticals

  • 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 · Device: PicoSure Device

Interventions

  • DevicePicoSure Pro Device

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

  • DevicePicoSure Device

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

  • DrugTopical Cosmeceuticals

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

05

What researchers measure

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).

    Time frame: 30 day follow up

06

Study locations

2 sites
  • Center for Dermatology and Laser Surgery
    Sacramento, California 95819, United States
  • Cynosure, Inc.
    Westford, Massachusetts 01886, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05102617
Lead sponsor
Cynosure, Inc.
Responsible party
Sponsor
First posted
Nov 1, 2021
Start date
Oct 21, 2021
Primary completion
Mar 15, 2023
Completion
Mar 15, 2023
Last update
Jan 9, 2024

Study contacts

Jennifer Civiok
study director · Director of Clinical Research
Sean Doherty
principal investigator · Cynosure, Inc.
Emil Tanghetti
principal investigator · Center for Dermatology and Laser Surgery

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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