An interventional study of Profound in Cellulite, sponsored by Syneron Medical. Completed at 2 sites in United States. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-25.
Sponsored by Syneron Medical · Not applicable, Interventional, and Treatment
Among 48 studies in Cellulite with a site in United States — none open to participants now, 1 under way, none of them phase 3. Cellulite · United States.
Among the 48 studies in Cellulite with a site in United States, this one is the 26th largest by enrollment of the 44 interventional ones that give a count, is one of 2 that started in 2017, is one of 20 with no phase, and was the 14th registered.
71 studies on the registry are indexed under Cellulite; 3 are open to participants now.
Browse Cellulite studies →None of the 48 studies in Cellulite with a site in United States is open now.
Of the 1 Cellulite studies recruiting now, 1 (100%) set no upper age limit and 0 (0%) stop at 75 or younger; 0 take children under 18; 1 take healthy volunteers.
This study: 18 Years to 60 Years · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
48 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2017.
This study's enrollment of 31 is close to the median of 34 across 65 interventional studies indexed under Cellulite.
Median enrollment 44 across the 44 interventional studies, 9 across the 4 observational. Of the 44 that completed or were terminated, 29 (66%) have results posted.
This tab as a report to print or save as PDF → With an account.
40 of 48 have an industry lead sponsor. The 10 most frequent:
Syneron Medical is the lead sponsor of 41 studies on the registry; none are open to participants now.
Syneron Medical has 3 studies filed under Cellulite — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 48 studies in Cellulite with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Clinical Study to Evaluate the Performance of the Profound System for the Treatment of Cellulite.
Up to 60 healthy female volunteers, seeking cellulite treatment, 18 to 60 years of age from up to 3 investigational sites.
Prospective, open-label, baseline-controlled, two arms, randomized, clinical study to evaluate the Profound device using the Dermal and SubQ Cartridges for minimally-invasive treatment of the upper thighs and buttocks cellulite appearance.
The treatment areas of the study subjects will be divided into two arms:
Methodology described in protocol to evaluate efficacy of treatments will be carried out at each visit.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single Profound treatment with the Dermal and/or SubQ cartridges to bra bulge, above the knees or upper arms
Device: Profound
The main intent of the Profound Dermal and Subdermal cartridges for cellulite treatment is to utilize a minimally-invasive approach to directly deliver radiofrequency (RF) energy into tissue through pairs of micro-electrode needles and use temperature sensors within the needles to reliably create fractional thermal injuries within the skin.
Improvement in Global Aesthetic Appearance of Cellulite in Treated Areas, as Assessed by Study Investigator Evaluations
Evaluate the improvement in global aesthetic appearance of cellulite in treated areas following a single dermal and/or subcutaneous treatment with Profound, as assessed by study investigators at 1,3 and 6 months post treatment visit. Investigators used the following scale: 0=No Change; 1= 1-24% improvement; 2=25-49% improvement; 3=50-74% improvement; 4=75-100% improvement. The analysis calculates the improvement over 25% (grades 2-4)
Time frame: 1,3 and 6 months post-treatment
Improvement in Skin Tightening/Laxity in Treated Areas, as Assessed by Study Investigator Evaluations
Evaluate the improvement in skin tightening in treated areas following a single dermal and/or subcutaneous treatment with Profound, as assessed by study investigators at 1 and 6 months post treatment visit. Investigators used the following scale: (0) No tightening/firmness; (1) Slightly visible tightening/firmness; (2) Visible tightening/firmness; (3) Very visible tightening/firmness. The analysis calculates the skin tightening improvement graded: (2) Visible tightening/firmness and (3) Very visible tightening/firmness
Time frame: 1, 3 and 6 months post treatment visit.
Investigator Satisfaction - by Questionnaire
Evaluate Investigator satisfaction at 1, 3, and 6 months post-treatment visit, using a satisfaction scale \[(-2) Very dissatisfied, (-1) Dissatisfied, (0) No opinion, (1) Satisfied, (2) Very satisfied\]. The analysis quantify investigator satisfaction (grades 1-2)
Time frame: 1, 3, and 6 months post-treatment visit
Subject Satisfaction and Improvement - by Questionnaire
Evaluate subject satisfaction at 1, 3, and 6 months post-treatment visit, using a satisfaction and improvement scale \[(-2) Very dissatisfied, (-1) Dissatisfied, (0) No opinion, (1) Satisfied, (2) Very satisfied\]. The analysis quantify subject satisfaction (grades 1-2)
Time frame: 1, 3, and 6 months post-treatment visit
| Milestone | Treated on the Suprapatellar | Treated on the Upper Arms | Treated on the Braline |
|---|---|---|---|
| Started | 17 | 11 | 3 |
| Completed | 17 | 10 | 3 |
| Not completed | 0 | 1 | 0 |
Evaluate the improvement in global aesthetic appearance of cellulite in treated areas following a single dermal and/or subcutaneous treatment with Profound, as assessed by study investigators at 1,3 and 6 months post treatment visit. Investigators used the following scale: 0=No Change; 1= 1-24% improvement; 2=25-49% improvement; 3=50-74% improvement; 4=75-100% improvement. The analysis calculates the improvement over 25% (grades 2-4)
| Investigator Assessments | Treated on the Suprapatellar | Treated on the Upper Arms | Treated on the Braline |
|---|---|---|---|
| Over 25% Improvement at 1 month FU | 11 | 7 | 4 |
| Over 25% Improvement at 3 month FU | 16 | 10 | 5 |
| Over 25% Improvement at 6 month FU | 15 | 9 | 4 |
Evaluate the improvement in skin tightening in treated areas following a single dermal and/or subcutaneous treatment with Profound, as assessed by study investigators at 1 and 6 months post treatment visit. Investigators used the following scale: (0) No tightening/firmness; (1) Slightly visible tightening/firmness; (2) Visible tightening/firmness; (3) Very visible tightening/firmness. The analysis calculates the skin tightening improvement graded: (2) Visible tightening/firmness and (3) Very visible tightening/firmness
| Investigator Assessments | Treated on the Suprapatellar | Treated on the Upper Arms | Treated on the Braline |
|---|---|---|---|
| Visible + very visible tightening at 1-month FU | 9 | 3 | 4 |
| Visible + very visible tightening at 3-month FU | 14 | 8 | 4 |
| Visible + very visible tightening at 6-month FU | 15 | 8 | 4 |
Evaluate Investigator satisfaction at 1, 3, and 6 months post-treatment visit, using a satisfaction scale \[(-2) Very dissatisfied, (-1) Dissatisfied, (0) No opinion, (1) Satisfied, (2) Very satisfied\]. The analysis quantify investigator satisfaction (grades 1-2)
| Investigator Assessments | Treated on the Suprapatellar | Treated on the Upper Arms | Treated on the Braline |
|---|---|---|---|
| Investigator Satisfaction Grades 1-2 at 1mo FU | 13 | 8 | 4 |
| Investigator Satisfaction Grades 1-2 at 3mo FU | 21 | 10 | 4 |
| Investigator Satisfaction Grades 1-2 at 6mo FU | 17 | 9 | 4 |
Evaluate subject satisfaction at 1, 3, and 6 months post-treatment visit, using a satisfaction and improvement scale \[(-2) Very dissatisfied, (-1) Dissatisfied, (0) No opinion, (1) Satisfied, (2) Very satisfied\]. The analysis quantify subject satisfaction (grades 1-2)
| Subject Assessments | Treated on the Suprapatellar | Treated on the Upper Arms | Treated on the Braline |
|---|---|---|---|
| Subject Satisfaction Grades 1-2 at 1mo FU | 13 | 8 | 2 |
| Subject Satisfaction Grades 1-2 at 3mo FU | 20 | 10 | 2 |
| Subject Satisfaction Grades 1-2 at 6mo FU | 17 | 10 | 4 |
Collected over The period of time over which adverse event data were collected is from treatment visit until 6 month post treatment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treated on the Suprapatellar | 0/17 (0%) | 0/17 (0%) | 1/17 (5.9%) |
| Treated on the Upper Arms | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Treated on the Braline | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Event | Treated on the Suprapatellar | Treated on the Upper Arms | Treated on the Braline |
|---|---|---|---|
| BruisingSkin and subcutaneous tissue disorders | 1/17 | 0/11 | 0/3 |
| ItchingSkin and subcutaneous tissue disorders | 1/17 | 0/11 | 0/3 |
Subjects treated with Profound SubQ, Dermal or both cartridges. Each subject was treated in two contralateral areas. If each area was treated differently (e.g. different cartridge or parameters used) it was assessed separately.
| Age, Categorical(Participants) | Treated on the Suprapatellar | Treated on the Upper Arms | Treated on the Braline | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 17 | 11 | 3 | 31 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Treated on the Suprapatellar | Treated on the Upper Arms | Treated on the Braline | Total |
|---|---|---|---|---|
| Mean | 49.4 ± 8.8 | 53.8 ± 6.8 | 46.7 ± 14.6 | 50.7 ± 8.8 |
| Sex: Female, Male(Participants) | Treated on the Suprapatellar | Treated on the Upper Arms | Treated on the Braline | Total |
|---|---|---|---|---|
| Female | 17 | 11 | 3 | 31 |
| Male | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Treated on the Suprapatellar | Treated on the Upper Arms | Treated on the Braline | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 17 | 11 | 3 | 31 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Treated on the Suprapatellar | Treated on the Upper Arms | Treated on the Braline | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 17 | 11 | 3 | 31 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Treated on the Suprapatellar | Treated on the Upper Arms | Treated on the Braline | Total |
|---|---|---|---|---|
| United States | 17 | 11 | 3 | 31 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2017 to primary completion in Nov 2018, 13 months.
Results were first posted in Jun 2019, 7 months after primary completion.
Of 20 interventional studies with no phase under Cellulite, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 14. This study's 13 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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