WrinkleNCT05096247

Post Market Study To Collect Efficacy Data For The Treatment Of Wrinkles With A Radiofrequency Device

A study testing TempSure and Icon in people with Wrinkle and Benign Pigmented Lesions, run by Cynosure, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The intended use of the RF (radiofrequency) device used in this study is to assess the efficacy of the handpiece for the treatment of facial wrinkles. If the other device (Intense Pulsed Light) laser in this study is used, the intended use will be for the treatment of benign pigmented and/or vascular lesions. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Wrinkle, Benign Pigmented Lesions, Benign Vascular Lesions
What is being tested?: TempSure and Icon
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 3 sitesUnited States
Study dates: 3 Sep 2021to 13 Sep 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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.
Agrees to be treated with the TempSure device.
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 pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
The subject has a cut, wound, or infected skin on the area to be treated.
The subject is on local, oral, or systemic anesthetic agents.
The subject has nerve insensitivity to heat in the treatment area.
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.
The subject is using systemic steroids (e.g. prednisone, dexamethasone) prior to or during the course of treatment.

Show all 11Show fewer

The subject has a medical condition or is receiving treatment that significantly compromise healing response.
The subject has a history of light-induced seizures.
The subject has a history of skin photosensitivity disorders.
The subject has a history of hypertrophic scars or keloid formation.
The subject has a history of radiation therapy in area to be treated.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Saluja Cosmetic and Laser Center
Huntersville, North Carolina, 28078
Excellent Vision
Portsmouth, New Hampshire, 03801
Cynosure
Westford, Massachusetts, 01886

Other trials in United States

About this study

Conditions: Wrinkle, Benign Pigmented Lesions, Benign Vascular Lesions
Being tested: TempSure, Icon

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TempSureDevice
This device is an RF device.
IconDevice
This device works with IPL (Intense Pulsed Light) handpieces.

Study groups in NCT05096247
Study group	Role	What they receive
Treatment with RF Device	Experimental	Subjects in this arm of the study will be treated with the radiofrequency device, and will receive up to 4 treatments on the face. Receives: Device: TempSure
Treatment with IPL and RF Device	Experimental	Subjects treated in this arm of the study will receive 2 treatments with just the radiofrequency device and then 2 treatments with both the radiofrequency and the IPL laser. Receives: Device: TempSure; Device: Icon

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects Who Noticed Improvement
Subjects graded themselves on a scale ranging from "Worsened" to "Very Much Improved" at the follow up visit. The number of subjects who graded themselves as "Improved" was reported.
Measured: 12 week follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Sep 202113 Sep 2022

First posted27 Oct 2021
Study start3 Sep 2021
Primary completion13 Sep 2022
Study completion13 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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
Model description: One site will enroll patients to be treated with the the RF device, and the other site will enroll patients to be treated with the RF device and the Intense Pulsed Light (IPL) laser.
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05096247
Sponsor's protocol ID: 7027-PM01-2021
Status last verified: Nov 2023
First submitted: 15 Oct 2021
Last updated: 28 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.
PubMed 31896400

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Wrinkle trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post Market Study To Collect Efficacy Data For The Treatment Of Wrinkles With A Radiofrequency Device
ClinicalTrials.gov ID: NCT05096247
Acronym / sponsor ID: 7027-PM01-2021
Conditions: Wrinkle, Benign Pigmented Lesions, Benign Vascular Lesions
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Cynosure, Inc.Industry (pharma, biotech, devices)
Study start: 3 Sep 2021 (actual)
Primary completion: 13 Sep 2022 (actual)
Study completion: 13 Sep 2022 (actual)
First posted: 27 Oct 2021 (actual)
Results: Posted 28 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: One site will enroll patients to be treated with the the RF device, and the other site will enroll patients to be treated with the RF device and the Intense Pulsed Light (IPL) laser.

Arm	Type	Receives
Treatment with RF Device	Experimental	Device: TempSureSubjects in this arm of the study will be treated with the radiofrequency device, and will receive up to 4 treatments on the face.
Treatment with IPL and RF Device	Experimental	Device: TempSure, Device: IconSubjects treated in this arm of the study will receive 2 treatments with just the radiofrequency device and then 2 treatments with both the radiofrequency and the IPL laser.

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.
Agrees to be treated with the TempSure device.
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 (11 listed)

Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
The subject has a cut, wound, or infected skin on the area to be treated.
The subject is on local, oral, or systemic anesthetic agents.
The subject has nerve insensitivity to heat in the treatment area.
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.

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
TempSureThis device is an RF device.	Device	Treatment with IPL and RF Device, Treatment with RF Device
IconThis device works with IPL (Intense Pulsed Light) handpieces.	Device	Treatment with IPL and RF Device

Primary outcome

Number of Subjects Who Noticed Improvement
Time frame: 12 week follow up
Subjects graded themselves on a scale ranging from "Worsened" to "Very Much Improved" at the follow up visit. The number of subjects who graded themselves as "Improved" was reported.

Results and safety

Results posted to the registry on 28 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment With RF Device	13	13
Treatment With IPL and RF Device	35	35

Primary outcome: Number of Subjects Who Noticed Improvement

Time frame: 12 week follow up. Count of participants. Unit: Participants

Measure	Treatment With RF Device n = 13	Treatment With IPL and RF Device n = 35
Value	10	34

Adverse events

Time frame: Subjects had their adverse events collected throughout their participation in the study, approximately 12 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment With RF Device	0 of 13 (0%)	13 of 13 (100%)	0 of 13
Treatment With IPL and RF Device	0 of 35 (0%)	5 of 35 (14.3%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31896400Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.
Individual participant dataSharing planned: No

Related trials for Wrinkle

Not yet recruiting
A Study to Evaluate the Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Deficiencies
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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

Cynosure, Inc.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing TempSure and Icon in people with Wrinkle and Benign Pigmented Lesions, run by Cynosure, Inc. at 3 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 11 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 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Yes. Results are posted in the registry (first posted 28 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Subjects Who Noticed Improvement (time frame: 12 week follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05096247, which also lists 1 linked publication.

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 28 Nov 2023.