ClinicalTrials.gg
Sign In
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. (part of Cynosure Lutronic, Inc.) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Mar 2023, 3 years 7 months ago, and no results have been posted to the registry.
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

Browse trials for

03

In context

Cicatrix

611 studies on the registry are indexed under Cicatrix; 114 are open to participants now.

This study's enrollment of 23 is below the median of 40 across 512 interventional studies indexed under Cicatrix.

Browse Cicatrix studies →

Lead sponsor

Cynosure, Inc. is the lead sponsor of 52 studies on the registry; 2 are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 16 (76%) have results posted.

First submitted before Cynosure, Inc. became part of Cynosure Lutronic, Inc..

Browse Cynosure, Inc. studies →All Cynosure Lutronic, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

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.

06

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

07

Study locations

2 sites
  • Center for Dermatology and Laser Surgery
    Sacramento, California 95819, United States
  • Cynosure, Inc.
    Westford, Massachusetts 01886, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2021 to primary completion in Mar 2023, 16 months.

Of 33 industry-sponsored interventional studies with no phase under Cicatrix, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 20. This study's 16 months is above that.

Counting every sponsor, half of 206 studies reached it within 18 months; a quarter within 8 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 25, 2021
First posted
Nov 1, 2021
StartActual
Oct 21, 2021
Primary completionActual
Mar 15, 2023
CompletionActual
Mar 15, 2023
Last update
Jan 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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 ↗

Not currently enrolling

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

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Cicatrix →

Other studies from this sponsor

Cynosure, Inc. →

Start the discussion