Skin AgingNCT01783496

Thermage CPT for Treatment of Facial and Neck Laxity

A study testing Thermage CPT in people with Skin Aging, run by Valeant Pharmaceuticals 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 purpose of this study to evaluate treatment with the Thermage CPT system for facial and neck laxity. Read more about this study

Who is it for?: Ages 25 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Skin Aging
What is being tested?: Thermage CPT
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: Jan 2013to Feb 2014
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

25 - 65 years of age
Moderate facial and neck laxity
Subject has the ability to follow the study instructions, is willing to be available on the specific required study visit days, and is willing to complete all study visit procedures and assessments.
Subject must understand the research nature of this study and sign an Institutional Review Board (IRB)-approved informed consent prior to the performance of any study specific procedure or assessment.
Subject agrees not to undergo excluded procedures on the face and neck for the duration of study.

Who cannot join

Subject is pregnant or breast feeding, or trying to become pregnant for three months prior to or during the study.
Pacemaker, internal defibrillator, or other implanted electronic device
Subject has an active localized infection in the treatment area(s) or an uncontrolled systemic infection.
Subject has had prior cosmetic procedures on the treatment area(s) within six months of the baseline visit.

Trial locations and contacts

1 site in 1 country.

United States1 site

Solta Medical Aesthetic Center
Hayward, California, 94545

Other trials in United States

About this study

Official title: Clinical Comparison of the Thermage CPT™ System's Framed and Pattern Tips for Treatment of Facial and Neck Laxity

The purpose of this study to evaluate treatment with the Thermage CPT system for facial and neck laxity.

Conditions: Skin Aging
Being tested: Thermage CPT

What participants receive

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

Thermage CPTDevice
Treatment with Thermage patterned, total, or framed tip

Study groups in NCT01783496
Study group	Role	What they receive
Framed Tip	Active comparator	Treatment with Thermage CPT Framed Tip Receives: Device: Thermage CPT
Pattern Tip	Experimental	Treatment with the Thermage CPT Pattern Tip Receives: Device: Thermage CPT
Pattern Tip Group 2	Experimental	Treatment with the Thermage CPT Pattern tip Receives: Device: Thermage CPT
Total Tip	Experimental	Treatment with the Thermage CPT Total tip Receives: Device: Thermage CPT
Framed and Patterned Tip	Experimental	Split face treatment with the Thermage CPT Framed and Patterned tips Receives: Device: Thermage CPT
Total and Patterned Tip	Experimental	Split face treatment with the Thermage CPT Total and Patterned tips Receives: Device: Thermage CPT

What is being measured

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

Improvement in Laxity
Improvement in facial and neck laxity 6 months following treatment as assessed by Study Investigator using a Quartile Improvement Scale score based upon a five point grading System: 4 - Very Significant Improvement (76-100%), 3 - Marked Improvement (51-75%), 2 - Moderate Improvement (26-50%), 1 - Minor/Mild Improvement (1-25%), or 0 - No Improvement.
Measured: 6 months

Secondary outcomes (2)

Improvement in Skin Laxity (Subject Self-assessed)
Improvement in facial and neck laxity 6 months following treatment as self-assessed by subjects using a Quartile Improvement Scale score based upon a five point grading System: 4 - Very Significant Improvement (76-100%), 3 - Marked Improvement (51-75%), 2 - Moderate Improvement (26-50%), 1 - Minor/Mild Improvement (1-25%), or 0 - No Improvement.
Measured: 6 months
Subject Satisfaction With Treatment Results
subjects were asked to provide satisfaction with treatment results, using the Likert Satisfaction Scale. Scoring was based upon a five point grading System: 5 - Very Satisfied, 4 - Satisfied, 3 - Neither Satisfied nor Dissatisfied, 2 - Dissatisfied, or 1 - Very Dissatisfied.
Data are presented as the proportion of subjects showing improvement as defined as a score of 4 or greater ('satisfied' or 'very satisfied').
Measured: 6 months

Timeline

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

Jan 2013Feb 2014

First posted5 Feb 2013 (estimated)
Study startJan 2013
Primary completionFeb 2014
Study completionFeb 2014

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 AgingStudies 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: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01783496
Sponsor's protocol ID: 13-136-TM-T
Status last verified: May 2017
First submitted: 31 Jan 2013
Last updated: 9 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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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Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Comparison of the Thermage CPT™ System's Framed and Pattern Tips for Treatment of Facial and Neck Laxity
ClinicalTrials.gov ID: NCT01783496
Acronym / sponsor ID: 13-136-TM-T
Conditions: Skin Aging
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Valeant PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jan 2013
Primary completion: Feb 2014 (actual)
Study completion: Feb 2014 (actual)
First posted: 5 Feb 2013 (estimated)
Results: Posted 17 Nov 2014

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 study to evaluate treatment with the Thermage CPT system for facial and neck laxity.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Framed Tip	Active comparator	Device: Thermage CPTTreatment with Thermage CPT Framed Tip
Pattern Tip	Experimental	Device: Thermage CPTTreatment with the Thermage CPT Pattern Tip
Pattern Tip Group 2	Experimental	Device: Thermage CPTTreatment with the Thermage CPT Pattern tip
Total Tip	Experimental	Device: Thermage CPTTreatment with the Thermage CPT Total tip
Framed and Patterned Tip	Experimental	Device: Thermage CPTSplit face treatment with the Thermage CPT Framed and Patterned tips
Total and Patterned Tip	Experimental	Device: Thermage CPTSplit face treatment with the Thermage CPT Total and Patterned tips

Who may qualify

Ages: 25 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

25 - 65 years of age
Moderate facial and neck laxity
Subject has the ability to follow the study instructions, is willing to be available on the specific required study visit days, and is willing to complete all study visit procedures and assessments.
Subject must understand the research nature of this study and sign an Institutional Review Board (IRB)-approved informed consent prior to the performance of any study specific procedure or assessment.
Subject agrees not to undergo excluded procedures on the face and neck for the duration of study.

Key exclusion criteria (4 listed)

Subject is pregnant or breast feeding, or trying to become pregnant for three months prior to or during the study.
Pacemaker, internal defibrillator, or other implanted electronic device
Subject has an active localized infection in the treatment area(s) or an uncontrolled systemic infection.
Subject has had prior cosmetic procedures on the treatment area(s) within six months of the baseline visit.

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
Thermage CPTTreatment with Thermage patterned, total, or framed tip	Device	Framed Tip, Framed and Patterned Tip, Pattern Tip, Pattern Tip Group 2, Total Tip, Total and Patterned Tip

Primary outcome

Improvement in Laxity
Time frame: 6 months
Improvement in facial and neck laxity 6 months following treatment as assessed by Study Investigator using a Quartile Improvement Scale score based upon a five point grading System: 4 - Very Significant Improvement (76-100%), 3 - Marked Improvement (51-75%), 2 - Moderate Improvement (26-50%), 1 - Minor/Mild Improvement (1-25%), or 0 - No Improvement.

2 secondary outcomes

Improvement in Skin Laxity (Subject Self-assessed)
Time frame: 6 months
Subject Satisfaction With Treatment Results
Time frame: 6 months

Results and safety

Results posted to the registry on 17 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Framed Tip	10	9
Pattern Tip	10	10
Pattern Tip Group 2	10	10
Total Tip	10	8
Framed and Patterned Tip	5	5
Total and Patterned Tip	5	4

Primary outcome: Improvement in Laxity

Time frame: 6 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Framed Tip n = 9	Pattern Tip n = 10	Pattern Tip Group 2 n = 10	Total Tip n = 8	Framed and Patterned Tip n = 5	Total and Patterned Tip n = 4
Value	0.6 (0.5)	1.0 (0.5)	0.9 (0.5)	1.3 (0.8)	0.9 (0.3)	1.4 (0.4)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Framed Tip	0 of 10 (0%)	3 of 10 (30%)	Not reported
Pattern Tip	1 of 10 (10%)	6 of 10 (60%)	Not reported
Pattern Tip Group 2	0 of 10 (0%)	1 of 10 (10%)	Not reported
Total Tip	1 of 10 (10%)	6 of 10 (60%)	Not reported
Framed and Patterned Tip	0 of 5 (0%)	2 of 5 (40%)	Not reported
Total and Patterned Tip	0 of 5 (0%)	1 of 5 (20%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Skin Aging

RecruitingObservational study
Improved Facial Skin Quality and Quality of Life After VYC-12L Treatment in Breast Cancer Survivors
Quality of Life, Breast Neoplasms
Active, not recruiting
Integrated Actionable Aging Assessment for Cancer Patients Pilot
Breast Cancer, Hodgkin Lymphoma
Not yet recruitingObservational study
Clinical Research on Deep-Plane Rejuran S Injection for Improvement in the Apperance of Periorbital Hollowing Using a Cannula Technique
Periorbital Hollowing, Skin Aging
Not yet recruitingObservational study
Clinical Evaluation of Dual-Plane Technique PN-Based Treatment for Horizontal Neck Lines Using DNA Fragment Opmizing Technology Polynucleotide (DOT PN)
Skin Aging, Horizontal Neck Lines
Recruiting
Ultraformer MPT Combined With Fractional CO2 Versus Fractional CO2 Alone for Facial Rejuvenation
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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.

Ronald Wheeland, MD principal investigator

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

Questions about this trial

What is this clinical trial studying?

A study testing Thermage CPT in people with Skin Aging, run by Valeant Pharmaceuticals 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 5 inclusion and 4 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 Jun 2017. 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 17 Nov 2014). 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?

Improvement in Laxity (time frame: 6 months). 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 NCT01783496.

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 Jun 2017.