Wrinkle ReductionNCT03285581
Pivotal Study of the Cutera truSculpt Radiofrequency Device for Wrinkle Reduction
A study testing truSculpt RF in people with Wrinkle Reduction, run by Cutera Inc. at 2 sites in United States.
Trial summary
The purpose of this pivotal investigation is to evaluate the safety and efficacy of the Cutera truSculpt™ radiofrequency (RF) Device for Wrinkle Reduction. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkle Reduction
- What is being tested?
- truSculpt RF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Aug 2017to 20 Dec 2018
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be able to understand and provide written informed consent and release of health information
- Male or Female, 25 to 65 years of age (inclusive)
- Fitzpatrick Skin Type I - VI (Appendix 4)
- Has visible wrinkles or skin laxity in the treatment area
- On the Fitzpatrick Classification Wrinkle Classification System subject has a pre-treatment score of 4-9 (inclusive) (Appendix 5)
- No use of tobacco products for at least 6 months and willing to refrain from use for the duration of the study
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- Subject must agree to not undergo any other cosmetic procedure(s) area, or start topical retinol products in the treatment area during the study period
- Subject must be willing to adhere to the follow-up schedule and study instructions
- Subject must be willing to adhere to the same diet and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study, within 10% of baseline weight measurement
- Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentations, educational, and/or marketing purposes
- For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant -
Who cannot join
- Participation in a clinical trial of a drug or another device in the target area within 3 months of study participation, or during the study.
- Any type of prior cosmetic treatment to the target area within 12 months of study participation e.g., radiofrequency, cryolipolysis, deoxycholate injection, or light-based treatments
- Prior injection of botulinum toxin, collagen, hyaluronic acid filler, or other dermal filler, and medium-depth to deep chemical peels, to the treatment area within 6 months of study participation
- History of systemic steroid use within 3 months; history of topical steroid use in the target area within 2 months
- History of systemic retinoid (isotretinoin) and therapeutic dose of Vitamin A within 6 months of study participation
- Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant
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- Has metal implant(s) within the body that are local to the treatment area, such as surgical clips, plates and screws (metal tooth fillings or crowns will not exclude subject participation), or has , artificial heart valves or artificial joints
- Clinically significant concurrent illness, such as diabetes mellitus, cardiovascular disease, peripheral vascular disease or pertinent neurological disorders that in the opinion of the Investigator will confound participation in the study
- Diagnosed or documented immune system disorders
- History of any disease or condition that could impair wound healing
- History of diseases stimulated by heat, such as recurrent herpes zoster in the treatment area, unless treatment is conducted following a prophylactic regimen
- History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing
- Infection, dermatitis, rash or other skin abnormality in the target area
- Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation
- Anticipated or planned need for surgery or hospitalization during the duration of the study
- Pregnant, nursing, or planning a pregnancy during the trial; or is a woman of child bearing potential but is not willing to use an acceptable method of contraception as determined by the Investigator
- As per the Investigator's discretion, any physical or psychological condition which might make it unsafe for the subject to participate in this study -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Westlake Dermatology
Austin, Texas, 78746
Cutera Research Center
Brisbane, California, 94005
About this study
Official title: Open-label, Prospective, Multicenter Pivotal Study of the Cutera truSculpt™ Radiofrequency Device for Wrinkle Reduction
The purpose of this pivotal investigation is to evaluate the safety and efficacy of the Cutera truSculpt™ radiofrequency (RF) Device for Wrinkle Reduction.
Read the detailed description
This is an Open-label, Prospective, Multicenter Pivotal Study of approximately 40 male or female subjects, age 25 to 65 years who desire RF treatment for wrinkle reduction and improvement in skin quality. Subjects will receive RF treatments with the Cutera truSculpt™ radiofrequency (RF) device. Subjects will return to the site after study treatments have been delivered 12 weeks post-final treatment.
- Conditions
- Wrinkle Reduction
- Being tested
- truSculpt RF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
truSculpt RFDevice
Also called Device: Treatment
Subjects will receive RF treatments
| Study group | Role | What they receive |
|---|---|---|
| truSculpt RF | Other | Subjects will receive RF treatments Receives: Device: truSculpt RF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Principal Investigator's Assessment of Improvement at 12 Weeks Post-final Treatment (Physician's Global Assessment of Improvement=GAIS)
GAIS: 4=Very Significant Improvement, 3=Significant Improvement, 2=Moderate Improvement, 1=Mild Improvement, 0=No Change Higher scores indicate better outcomes
Measured: 12 weeks post-final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start15 Aug 2017
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
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.
- Other trials for Wrinkle ReductionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutera Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Ronan, M.D., Principal investigator, Cutera Research CenterDaniel Friedmann, M.D., Principal investigator, Westlake Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285581
- Sponsor's protocol ID
- C-17-TS14
- Status last verified
- Aug 2023
- First submitted
- 14 Sep 2017
- Last updated
- 13 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Prospective, Multicenter Pivotal Study of the Cutera truSculpt™ Radiofrequency Device for Wrinkle Reduction
- ClinicalTrials.gov ID
- NCT03285581
- Acronym / sponsor ID
- C-17-TS14
- Conditions
- Wrinkle Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Cutera Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 18 Sep 2017 (actual)
- Results
- Posted 13 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pivotal investigation is to evaluate the safety and efficacy of the Cutera truSculpt™ radiofrequency (RF) Device for Wrinkle Reduction.
Detailed description
This is an Open-label, Prospective, Multicenter Pivotal Study of approximately 40 male or female subjects, age 25 to 65 years who desire RF treatment for wrinkle reduction and improvement in skin quality. Subjects will receive RF treatments with the Cutera truSculpt™ radiofrequency (RF) device. Subjects will return to the site after study treatments have been delivered 12 weeks post-final treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| truSculpt RF | Other | Device: truSculpt RFSubjects will receive RF treatments |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Must be able to understand and provide written informed consent and release of health information
- Male or Female, 25 to 65 years of age (inclusive)
- Fitzpatrick Skin Type I - VI (Appendix 4)
- Has visible wrinkles or skin laxity in the treatment area
- On the Fitzpatrick Classification Wrinkle Classification System subject has a pre-treatment score of 4-9 (inclusive) (Appendix 5)
Key exclusion criteria (17 listed)
- Participation in a clinical trial of a drug or another device in the target area within 3 months of study participation, or during the study.
- Any type of prior cosmetic treatment to the target area within 12 months of study participation e.g., radiofrequency, cryolipolysis, deoxycholate injection, or light-based treatments
- Prior injection of botulinum toxin, collagen, hyaluronic acid filler, or other dermal filler, and medium-depth to deep chemical peels, to the treatment area within 6 months of study participation
- History of systemic steroid use within 3 months; history of topical steroid use in the target area within 2 months
- History of systemic retinoid (isotretinoin) and therapeutic dose of Vitamin A within 6 months of study 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 |
|---|---|---|
| truSculpt RFAlso: Device: TreatmentSubjects will receive RF treatments | Device | truSculpt RF |
Primary outcome
Principal Investigator's Assessment of Improvement at 12 Weeks Post-final Treatment (Physician's Global Assessment of Improvement=GAIS)
Time frame: 12 weeks post-final treatment
GAIS: 4=Very Significant Improvement, 3=Significant Improvement, 2=Moderate Improvement, 1=Mild Improvement, 0=No Change Higher scores indicate better outcomes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Stephen Ronan, M.D. principal investigator
Cutera Research Center
Daniel Friedmann, M.D. principal investigator
Westlake Dermatology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing truSculpt RF in people with Wrinkle Reduction, run by Cutera 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 11 inclusion and 17 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 13 Sep 2023. 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?
Yes. Results are posted in the registry (first posted 13 Sep 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?
Principal Investigator's Assessment of Improvement at 12 Weeks Post-final Treatment (Physician's Global Assessment of Improvement=GAIS) (time frame: 12 weeks post-final treatment). 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 13 Sep 2023.