Skin QualityNCT03424161

Multi-Center, Clinical Evaluation of the Cutera Secret RF Device

A study testing Secret RF in people with Skin Quality, run by Cutera Inc. at 1 site in United States.

Completed

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

Trial summary

The objectives of this study are to evaluate the efficacy and safety of the Cutera Secret RF device. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Skin Quality
What is being tested?: Secret RF
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteUnited States
Study dates: 10 Jan 2018to 8 Oct 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 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subject must be able to read, understand and sign the Informed Consent Form.
Female or Male, age 18 and older
Willing to undergo treatments with Secret RF.
Willing to have very limited sun exposure and use sunscreen on the treatment area every day for the duration of the study, including the follow-up period.
Subject must adhere to the follow-up schedule and study instructions.
Agree to not undergo any other cosmetic procedure(s) or treatment(s) on the treatment area during the study and has no intention of having such procedures performed during the course of the study.
Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, (educational and/or marketing), publications, and any additional 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 prior to enrollment and during the entire course of the study.

Who cannot join

Participation in a clinical trial of another device or drug within 1 month of study participation, or during the study period.
History of clotting disorders and/or current use of blood thinning medications.
History of autoimmune disorders or diabetes.
Cardiac pacemaker or active implantable metal device in the treatment area.
Allergies to metals i.e. gold.
Has a history of squamous cell carcinoma or melanoma in the treatment area.

Show all 13Show fewer

Significant uncontrolled concurrent illness that in the opinion of the Investigator would make the subject unsuitable for inclusion.
History of any disease or condition that could impair wound healing.
History of keloid formation or abnormal/delayed wound healing.
History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.
Use of topical agents one week prior to treatment that may cause facial sensitivity.
Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including but not limited to, open lacerations or abrasions, hidradenitis, rash, infection , or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion).
As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study or a condition that would compromise the subject's ability to comply with the study requirements.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cutera Research Center
Brisbane, California, 94005

Other trials in United States

About this study

The objectives of this study are to evaluate the efficacy and safety of the Cutera Secret RF device.

Read the detailed description

This is a multi-center, study in approximately 40 subjects, ages 18 and older. Subjects will receive treatments and will be followed at 4 and 12 weeks post the final treatment.

Conditions: Skin Quality
Being tested: Secret RF

What participants receive

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

Secret RFDevice
Subjects will receive treatment with the Secret RF device

Study groups in NCT03424161
Study group	Role	What they receive
Secret RF	Other	Treatment with Secret RF for skin quality Receives: Device: Secret RF

What is being measured

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

Overall Aesthetic Improvement
Efficacy of treatment(s) with Cutera Secret RF measuring the global skin improvement at the 4 week follow-up visit, and at the 12 week follow-up visit as assessed by the study investigator using GAIS: Global Aesthetic Improvement Scale (+4=Very Significant Improvement, +3=Significant Improvement, +2=Moderate Improvement, +1=Mild Improvement, or 0=No Change Higher scores indicate better outcomes
Measured: at 4 weeks follow-up and 12 weeks follow-up

Timeline

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

10 Jan 20188 Oct 2018

First posted6 Feb 2018
Study start10 Jan 2018
Primary completion8 Oct 2018
Study completion8 Oct 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 Skin QualityStudies 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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03424161
Sponsor's protocol ID: C-18-SRF01
Status last verified: Sep 2023
First submitted: 25 Jan 2018
Last updated: 15 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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 Skin Quality trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-Center, Clinical Evaluation of the Cutera Secret RF Device
ClinicalTrials.gov ID: NCT03424161
Acronym / sponsor ID: C-18-SRF01
Conditions: Skin Quality
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Cutera Inc.Industry (pharma, biotech, devices)
Study start: 10 Jan 2018 (actual)
Primary completion: 8 Oct 2018 (actual)
Study completion: 8 Oct 2018 (actual)
First posted: 6 Feb 2018 (actual)
Results: Posted 15 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 objectives of this study are to evaluate the efficacy and safety of the Cutera Secret RF device.

Detailed description

This is a multi-center, study in approximately 40 subjects, ages 18 and older. Subjects will receive treatments and will be followed at 4 and 12 weeks post the final treatment.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Secret RF	Other	Device: Secret RFTreatment with Secret RF for skin quality

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Subject must be able to read, understand and sign the Informed Consent Form.
Female or Male, age 18 and older
Willing to undergo treatments with Secret RF.
Willing to have very limited sun exposure and use sunscreen on the treatment area every day for the duration of the study, including the follow-up period.
Subject must adhere to the follow-up schedule and study instructions.

Key exclusion criteria (13 listed)

Participation in a clinical trial of another device or drug within 1 month of study participation, or during the study period.
History of clotting disorders and/or current use of blood thinning medications.
History of autoimmune disorders or diabetes.
Cardiac pacemaker or active implantable metal device in the treatment area.
Allergies to metals i.e. gold.

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
Secret RFSubjects will receive treatment with the Secret RF device	Device	Secret RF

Primary outcome

Overall Aesthetic Improvement
Time frame: at 4 weeks follow-up and 12 weeks follow-up
Efficacy of treatment(s) with Cutera Secret RF measuring the global skin improvement at the 4 week follow-up visit, and at the 12 week follow-up visit as assessed by the study investigator using GAIS: Global Aesthetic Improvement Scale (+4=Very Significant Improvement, +3=Significant Improvement, +2=Moderate Improvement, +1=Mild Improvement, or 0=No Change Higher scores indicate better outcomes

Results and safety

Results posted to the registry on 15 Sep 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
Secret RF	27	10

Primary outcome: Overall Aesthetic Improvement

Time frame: at 4 weeks follow-up and 12 weeks follow-up. Mean (Standard Deviation). Unit: score on a scale

Measure	Secret RF n = 10
GAIS at the 4 week follow up	1.63 (0.92)
GAIS at the 12 week follow up	2 (0.71)

Population analysed: 3 subjects has GAIS measurements available at both the 4 and 12 week follow ups 5 subjects had GAIS measurements only available at the 4 week follow up 2 subjects had GAIS measurements only available at the 12 week follow up

Adverse events

Time frame: 12 weeks post final treatment, up to 8 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Secret RF	0 of 27 (0%)	27 of 27 (100%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 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, MD principal investigator

Cutera Research Center

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

Questions about this trial

What is this clinical trial studying?

A study testing Secret RF in people with Skin Quality, run by Cutera Inc. at 1 site 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 8 inclusion and 13 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 15 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 1 site 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 15 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?

Overall Aesthetic Improvement (time frame: at 4 weeks follow-up and 12 weeks 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 NCT03424161.

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 15 Sep 2023.