CelluliteNCT03078647
Profound Dermal and SubQ Cartridges for the Treatment of Cellulite
A study testing Profound in people with Cellulite, run by Syneron Medical at 2 sites in United States.
Trial summary
Clinical Study to Evaluate the Performance of the Profound System for the Treatment of Cellulite. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cellulite
- What is being tested?
- Profound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Sep 2017to 31 Jan 2019
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent to participate in the study.
- Female subjects, ≥ 18 and ≤ 60 years of age at the time of enrollment
- Fitzpatrick Skin Type I to VI.
- Subjects seeking treatment of cellulite in the upper thighs and buttocks areas.
- Subject cellulite stage II or III as graded using Nurnberger-Muller scale classification (Appendix III).
- Not pregnant, lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence).
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- Negative urine pregnancy test as tested prior to each treatment and at the last visit for women of child bearing potential (e.g. not menopause).
- General good health confirmed by medical history and skin examination of the treated area.
- Willing to receive the proposed Profound treatment.
- Willing to follow the treatment and follow-up schedule and post-treatment care instructions.
- Willing to have photographs and images taken of the treated areas to be used de-identified in evaluations, publications and presentations.
Who cannot join
- Subject cellulite stage 0 or I as graded using Nurnberger-Muller scale classification (Appendix III).
- Subject had surgery or any other procedure for cellulite in the last 6 months.
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
- Known allergy to lidocaine or epinephrine or antibiotics.
- Active malignancy or history of malignancy in the past 5 years.
- Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
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- Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders (i.e. any disease state that in the opinion of the Physician would interfere with the anesthesia, treatment, or healing process).
- Having a known anti-coagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician discretion).
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
- Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen.
- History of significant lymphatic drainage problems.
- History of cancer which required lymph node biopsy or dissection.
- Suffering from significant skin conditions in treatment areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course.
- History of keloid scarring, abnormal wound healing and / or prone to bruising.
- History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders.
- Use of isotretinoin (Accutane) within 6 months of treatment or during the study.
- Subject on systemic corticosteroid therapy 6 months prior to and throughout the course of the study.
- Dysplastic nevi in the area to be treated.
- Participation in a study of another device or drug within 3 month prior to enrollment or during this study.
- Subject has palpable lymphadenopathy at any visit. Standard palpation techniques will be used.
- Subjects with history of severe edema.
- As per the Investigator's discretion, any physical or mental condition that might make it unsafe for subject to participate in this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Girish Munavalli
Charlotte, North Carolina, 28270
Macrene Alexiades
New York, New York, 10028
About this study
Official title: Clinical Study to Evaluate the Safety and Efficacy Performance of the Profound System Using the Dermal and Sub-dermal (SubQ) Cartridges for the Treatment of Cellulite
Clinical Study to Evaluate the Performance of the Profound System for the Treatment of Cellulite.
Read the detailed description
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:
- Arm 1 - the upper thigh/buttock on the left or right side of the body will undergo a single Profound treatment utilizing the Dermal and SubQ Cartridges
- Arm 2 - the contralateral upper thigh/buttock side of the body will undergo a single Profound treatment utilizing the SubQ Cartridge only.
Methodology described in protocol to evaluate efficacy of treatments will be carried out at each visit.
- Conditions
- Cellulite
- Being tested
- Profound
- Medical subject headings
- Cellulite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProfoundDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Profound treatment to small areas | Experimental | Single Profound treatment with the Dermal and/or SubQ cartridges to bra bulge, above the knees or upper arms Receives: Device: Profound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1,3 and 6 months post-treatment
Secondary outcomes (3)
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
Measured: 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)
Measured: 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)
Measured: 1, 3, and 6 months post-treatment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start13 Sep 2017
- Primary completion2 Nov 2018
- Study completion31 Jan 2019
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 (5)Papers the sponsor has linked to this study.
- Other trials for CelluliteStudies 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Girish Munavalli, MD, Principal investigator, Laser & Vein Specialists of the Carolinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078647
- Sponsor's protocol ID
- DHF21711
- Status last verified
- Jun 2019
- First submitted
- 22 Feb 2017
- Last updated
- 25 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rawlings AV. Cellulite and its treatment. Int J Cosmet Sci. 2006 Jun;28(3):175-90. doi: 10.1111/j.1467-2494.2006.00318.x.
PubMed 18489274Rossi AB, Vergnanini AL. Cellulite: a review. J Eur Acad Dermatol Venereol. 2000 Jul;14(4):251-62. doi: 10.1046/j.1468-3083.2000.00016.x.
PubMed 11204512Alexiades M, Berube D. Randomized, blinded, 3-arm clinical trial assessing optimal temperature and duration for treatment with minimally invasive fractional radiofrequency. Dermatol Surg. 2015 May;41(5):623-32. doi: 10.1097/DSS.0000000000000347.
PubMed 25915628Alexiades M, Munavalli G, Goldberg D, Berube D. Prospective Multicenter Clinical Trial of a Temperature-Controlled Subcutaneous Microneedle Fractional Bipolar Radiofrequency System for the Treatment of Cellulite. Dermatol Surg. 2018 Oct;44(10):1262-1271. doi: 10.1097/DSS.0000000000001593.
PubMed 30222637Alexiades M, Munavalli GS. Single Treatment Protocol With Microneedle Fractional Radiofrequency for Treatment of Body Skin Laxity and Fat Deposits. Lasers Surg Med. 2021 Oct;53(8):1026-1031. doi: 10.1002/lsm.23397. Epub 2021 Mar 25.
PubMed 33764552
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Safety and Efficacy Performance of the Profound System Using the Dermal and Sub-dermal (SubQ) Cartridges for the Treatment of Cellulite
- ClinicalTrials.gov ID
- NCT03078647
- Acronym / sponsor ID
- DHF21711
- Conditions
- Cellulite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- 2 Nov 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 13 Mar 2017 (actual)
- Results
- Posted 18 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical Study to Evaluate the Performance of the Profound System for the Treatment of Cellulite.
Detailed description
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:
- Arm 1 - the upper thigh/buttock on the left or right side of the body will undergo a single Profound treatment utilizing the Dermal and SubQ Cartridges
- Arm 2 - the contralateral upper thigh/buttock side of the body will undergo a single Profound treatment utilizing the SubQ Cartridge only.
Methodology described in protocol to evaluate efficacy of treatments will be carried out at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Profound treatment to small areas | Experimental | Device: ProfoundSingle Profound treatment with the Dermal and/or SubQ cartridges to bra bulge, above the knees or upper arms |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Signed informed consent to participate in the study.
- Female subjects, ≥ 18 and ≤ 60 years of age at the time of enrollment
- Fitzpatrick Skin Type I to VI.
- Subjects seeking treatment of cellulite in the upper thighs and buttocks areas.
- Subject cellulite stage II or III as graded using Nurnberger-Muller scale classification (Appendix III).
Key exclusion criteria (22 listed)
- Subject cellulite stage 0 or I as graded using Nurnberger-Muller scale classification (Appendix III).
- Subject had surgery or any other procedure for cellulite in the last 6 months.
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
- Known allergy to lidocaine or epinephrine or antibiotics.
- Active malignancy or history of malignancy in the past 5 years.
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 |
|---|---|---|
| ProfoundThe 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. | Device | Profound treatment to small areas |
Primary outcome
Improvement in Global Aesthetic Appearance of Cellulite in Treated Areas, as Assessed by Study Investigator Evaluations
Time frame: 1,3 and 6 months post-treatment
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)
3 secondary outcomes
Improvement in Skin Tightening/Laxity in Treated Areas, as Assessed by Study Investigator Evaluations
Time frame: 1, 3 and 6 months post treatment visit.
Investigator Satisfaction - by Questionnaire
Time frame: 1, 3, and 6 months post-treatment visit
Subject Satisfaction and Improvement - by Questionnaire
Time frame: 1, 3, and 6 months post-treatment visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18489274Rawlings AV. Cellulite and its treatment. Int J Cosmet Sci. 2006 Jun;28(3):175-90. doi: 10.1111/j.1467-2494.2006.00318.x.
- Background: PubMed 11204512Rossi AB, Vergnanini AL. Cellulite: a review. J Eur Acad Dermatol Venereol. 2000 Jul;14(4):251-62. doi: 10.1046/j.1468-3083.2000.00016.x.
- Background: PubMed 25915628Alexiades M, Berube D. Randomized, blinded, 3-arm clinical trial assessing optimal temperature and duration for treatment with minimally invasive fractional radiofrequency. Dermatol Surg. 2015 May;41(5):623-32. doi: 10.1097/DSS.0000000000000347.
- Background: PubMed 30222637Alexiades M, Munavalli G, Goldberg D, Berube D. Prospective Multicenter Clinical Trial of a Temperature-Controlled Subcutaneous Microneedle Fractional Bipolar Radiofrequency System for the Treatment of Cellulite. Dermatol Surg. 2018 Oct;44(10):1262-1271. doi: 10.1097/DSS.0000000000001593.
- Derived from this study: PubMed 33764552Alexiades M, Munavalli GS. Single Treatment Protocol With Microneedle Fractional Radiofrequency for Treatment of Body Skin Laxity and Fat Deposits. Lasers Surg Med. 2021 Oct;53(8):1026-1031. doi: 10.1002/lsm.23397. Epub 2021 Mar 25.
- 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.
Girish Munavalli, MD principal investigator
Laser & Vein Specialists of the Carolinas
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Profound in people with Cellulite, run by Syneron Medical 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 22 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 25 Jun 2019. 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 18 Jun 2019). 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 Global Aesthetic Appearance of Cellulite in Treated Areas, as Assessed by Study Investigator Evaluations (time frame: 1,3 and 6 months post-treatment). 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 NCT03078647, which also lists 5 linked publications.
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 25 Jun 2019.