WrinkleNCT05102617
Post Market Usability Evaluation Of The PicoSure Pro Device
A study testing PicoSure Pro Device, PicoSure Device and Topical Cosmeceuticals in people with Wrinkle and Acne Scars, run by Cynosure, Inc. at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wrinkle, Acne Scars, Benign Epidermal Pigmented Lesions
- What is being tested?
- PicoSure Pro Device, PicoSure Device and Topical Cosmeceuticals
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Oct 2021to 15 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Dermatology and Laser Surgery
Sacramento, California, 95819
Cynosure, Inc.
Westford, Massachusetts, 01886
About this study
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.
- Conditions
- Wrinkle, Acne Scars, Benign Epidermal Pigmented Lesions, Benign Dermal Pigmented Lesions, Tattoo Removal
- Being tested
- PicoSure Pro Device, PicoSure Device, Topical Cosmeceuticals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PicoSure Pro DeviceDevice
This device will be used for up to 4 treatments over the designated areas.
PicoSure DeviceDevice
This device will be used for up to 4 treatments over the designated areas.
Topical CosmeceuticalsDrug
Topical cosmeceuticals, such as a hydrating serum or cream, will be applied on the designated area.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: PicoSure Pro Device; Device: PicoSure Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 day follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start21 Oct 2021
- Primary completion15 Mar 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinkleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cynosure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Civiok, Study director, Director of Clinical ResearchSean Doherty, Principal investigator, Cynosure, Inc.Emil Tanghetti, Principal investigator, Center for Dermatology and Laser Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102617
- Sponsor's protocol ID
- 7051-PM01-2021
- Status last verified
- Jan 2024
- First submitted
- 25 Oct 2021
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Usability Evaluation Of The PicoSure Pro Device
- ClinicalTrials.gov ID
- NCT05102617
- Acronym / sponsor ID
- 7051-PM01-2021
- Conditions
- Wrinkle, Acne Scars, Benign Epidermal Pigmented Lesions, Benign Dermal Pigmented Lesions, Tattoo Removal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Cynosure, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 1 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Split-Face Device Only Treatment | Experimental | Device: PicoSure Pro Device, Device: PicoSure DeviceSubjects will receive a split face treatment with the PicoSure Pro and/or PicoSure devices using different device settings on each half of the face. |
| Group B: Split-Face Treatment with Cosmeceuticals | Experimental | Device: PicoSure Pro Device, Device: PicoSure Device, Drug: Topical CosmeceuticalsSubjects will receive a full face treatment with the PicoSure Pro or PicoSure device and will use topical cosmeceuticals on only half of their face. |
| Group C: Device Only Treatment | Experimental | Device: PicoSure Pro Device, Device: PicoSure DeviceSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PicoSure Pro DeviceThis device will be used for up to 4 treatments over the designated areas. | Device | Group A: Split-Face Device Only Treatment, Group B: Split-Face Treatment with Cosmeceuticals, Group C: Device Only Treatment |
| PicoSure DeviceThis device will be used for up to 4 treatments over the designated areas. | Device | Group A: Split-Face Device Only Treatment, Group B: Split-Face Treatment with Cosmeceuticals, Group C: Device Only Treatment |
| Topical CosmeceuticalsTopical cosmeceuticals, such as a hydrating serum or cream, will be applied on the designated area. | Drug | Group B: Split-Face Treatment with Cosmeceuticals |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Civiok study director
Director of Clinical Research
Sean Doherty principal investigator
Cynosure, Inc.
Emil Tanghetti principal investigator
Center for Dermatology and Laser Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PicoSure Pro Device, PicoSure Device and Topical Cosmeceuticals in people with Wrinkle and Acne Scars, run by Cynosure, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grading of Pre-Treatment vs. Follow Up Images (time frame: 30 day follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.