CelluliteNCT02489994
Performance of the ePrime System for Cellulite
A study testing ePrime in people with Cellulite, run by Syneron Medical at 4 sites in United States.
Trial summary
Clinical Study to Evaluate the Performance of the ePrime System for the Treatment of Cellulite. Read more about this study
- Who is it for?
- Ages 25 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cellulite
- What is being tested?
- ePrime
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects seeking treatment of cellulite in the upper thighs and buttocks areas.
- Subject have cellulite stage II or III as graded using Nurnberger-Muller scale clasification (Appendix III)
- Healthy female subjects ages 25 to 60 years of age
- Informed consent process completed and subject signed consent
- Willing to receive the proposed ePrime treatment and follow-up protocol
- Not pregnant or 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)
- Willing to have photographs taken of the treated areas to be used de-identified in evaluations, publications and presentations
Who cannot join
- 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
- 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)
Show all 21Show fewer
- Having a known anticoagulative 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 the treated 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, if treatments of cellulite were involved
- 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 which might make it unsafe for the subject to participate in this study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Girish Munavalli
Charlotte, North Carolina, 28270
David Goldberg
Hackensack, New Jersey, 07601
Bowes Leyda
Miami, Florida, 33133
Macrene Alexiades
New York, New York, 10028
About this study
Official title: Clinical Study to Evaluate the Performance of the ePrime System for the Treatment of Cellulite
Clinical Study to Evaluate the Performance of the ePrime System for the Treatment of Cellulite.
Read the detailed description
Up to 60 healthy adult volunteers seeking cellulite treatment, females of 25 to 60 years of age, from multiple investigational sites.
This is an open-label, multi-center study. Subjects in this study will receive a single subcutaneous treatment with the ePrime device in one treatment session according to the study protocol.
Prior to treatments, tissue to be treated will be injected with tumescence or local dermal infiltration solution according to the protocol. Subjects will return for follow-up (FU) visits at: 1 week, 1 month, 3 months and 6 months following the treatment.
Methodology described in protocol to evaluate efficacy of treatments will be carried out at each visit.
- Conditions
- Cellulite
- Being tested
- ePrime
- Medical subject headings
- Cellulite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePrimeDevice
The main intent of the ePrime for cellulite is to utilize a minimally-invasive approach to directly deliver 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 |
|---|---|---|
| all subjects | Experimental | Treatment with the ePrime radiofrequency microneedling device in the upper thighs and buttocks Receives: Device: ePrime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in cellulite compared to baseline for the upper thighs and buttocks, as assessed by blinded evaluation of clinical photographs
Evaluate the efficacy of a single dermal and subcutaneous treatment with ePrime for the upper thighs and buttocks cellulite as assessed by blinded evaluators at 3 months post treatment visit.
Measured: Baseline and 3 months post treatment visit
Secondary outcomes (5)
Improvement in cellulite compared to baseline for the upper thighs and buttocks, as assessed by blinded evaluation of clinical photographs
Evaluate the efficacy of a single dermal and subcutaneous treatment with ePrime for the upper thighs and buttocks cellulite as assessed by blinded evaluators at 6 months post treatment visit.
Measured: Baseline and 6 months post treatment visit
Number of Participants with Adverse Events
evaluate the safety of a single dermal and subcutaneous treatment with ePrime for the upper thighs and buttocks cellulite at 1 week post treatment, 1 month, 3 and 6 months following the treatment.
Measured: day 0 up to 7 months
Improvement in cellulite compared to baseline
Improvement in cellulite compared to baseline, as assessed by study investigators, using Nurnberger-Muller scale at 1 month, 3 and 6 months post treatment visit.
Measured: Baseline, 1 month, 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
Measured: 1, 3, and 6 months post-treatment visit
Subject satisfaction - by questionnaire
Evaluate subject satisfaction at 1, 3, and 6 months post-treatment visit, using a satisfaction scale
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 posted3 Jul 2015 (estimated)
- Study startOct 2014
- Primary completionAug 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Macrene Alexiades, MD, Principal investigator, Dermatology and Laser Surgery Center 955 Park Avenue, New York, NY, 10028Leyda Bowes, MD, Principal investigator, Bowes Dermatology, 3659 South Miami Avenue, Suite # 6008, Miami, FL 33133David Goldberg, MD, Principal investigator, Skin Laser & Surgery Specialist of NY/NJGirish Munavalli, MD, Principal investigator, Laser & Vein Specialists of the Carolinas, 1918 Randolph Road, Suite 550, Charlotte, NC 28270
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489994
- Sponsor's protocol ID
- DHF15911
- Status last verified
- Mar 2016
- First submitted
- 25 Jun 2015
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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 11204512
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Performance of the ePrime System for the Treatment of Cellulite
- ClinicalTrials.gov ID
- NCT02489994
- Acronym / sponsor ID
- DHF15911
- Conditions
- Cellulite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 3 Jul 2015 (estimated)
- Results
- Not posted in the source record
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 ePrime System for the Treatment of Cellulite.
Detailed description
Up to 60 healthy adult volunteers seeking cellulite treatment, females of 25 to 60 years of age, from multiple investigational sites.
This is an open-label, multi-center study. Subjects in this study will receive a single subcutaneous treatment with the ePrime device in one treatment session according to the study protocol.
Prior to treatments, tissue to be treated will be injected with tumescence or local dermal infiltration solution according to the protocol. Subjects will return for follow-up (FU) visits at: 1 week, 1 month, 3 months and 6 months following the treatment.
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 |
|---|---|---|
| all subjects | Experimental | Device: ePrimeTreatment with the ePrime radiofrequency microneedling device in the upper thighs and buttocks |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects seeking treatment of cellulite in the upper thighs and buttocks areas.
- Subject have cellulite stage II or III as graded using Nurnberger-Muller scale clasification (Appendix III)
- Healthy female subjects ages 25 to 60 years of age
- Informed consent process completed and subject signed consent
- Willing to receive the proposed ePrime treatment and follow-up protocol
Key exclusion criteria (21 listed)
- 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
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 |
|---|---|---|
| ePrimeThe main intent of the ePrime for cellulite is to utilize a minimally-invasive approach to directly deliver 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 | all subjects |
Primary outcome
Improvement in cellulite compared to baseline for the upper thighs and buttocks, as assessed by blinded evaluation of clinical photographs
Time frame: Baseline and 3 months post treatment visit
Evaluate the efficacy of a single dermal and subcutaneous treatment with ePrime for the upper thighs and buttocks cellulite as assessed by blinded evaluators at 3 months post treatment visit.
5 secondary outcomes
Improvement in cellulite compared to baseline for the upper thighs and buttocks, as assessed by blinded evaluation of clinical photographs
Time frame: Baseline and 6 months post treatment visit
Number of Participants with Adverse Events
Time frame: day 0 up to 7 months
Improvement in cellulite compared to baseline
Time frame: Baseline, 1 month, 3 and 6 months post treatment visit.
Investigator satisfaction - by questionnaire
Time frame: 1, 3, and 6 months post-treatment visit
Subject satisfaction - by questionnaire
Time frame: 1, 3, and 6 months post-treatment visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2016.
- 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.
- Individual participant dataSharing planned: Undecided
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Cellulite
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.
Macrene Alexiades, MD principal investigator
Dermatology and Laser Surgery Center 955 Park Avenue, New York, NY, 10028
Leyda Bowes, MD principal investigator
Bowes Dermatology, 3659 South Miami Avenue, Suite # 6008, Miami, FL 33133
David Goldberg, MD principal investigator
Skin Laser & Surgery Specialist of NY/NJ
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ePrime in people with Cellulite, run by Syneron Medical at 4 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 7 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 18 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Results are not available in the source record.
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 cellulite compared to baseline for the upper thighs and buttocks, as assessed by blinded evaluation of clinical photographs (time frame: Baseline and 3 months post treatment visit). 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 NCT02489994, which also lists 2 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 18 Mar 2016.