CelluliteNCT03981198
Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) for the Treatment of Cellulite
A study testing Soliton Rapid Acoustic Pulse (RAP) in people with Cellulite, run by Soliton at 1 site in United States.
Trial summary
Feasibility study is to evaluate the safety, tolerability and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the treatment of cellulite Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cellulite
- What is being tested?
- Soliton Rapid Acoustic Pulse (RAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2018to 5 Aug 2019
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female ages 18-65 years
- Participant seeking treatment of cellulite in the upper lateral thigh areas
- Participant presenting with cellulite Grade I or II on both thighs as graded using the Nurnberger-Muller scale classification (Appendix A)
- Participant has stable weight. Body Mass Index (B.M.I.) is ≤ 30
- Participant will not have any other cellulite treatments for 12 months before and throughout the 3-month follow-up
- Participant is willing to participate in study and adhere to follow-up schedule
- Participant is able to read and comprehend English
- Participant has completed Informed Consent Form
Who cannot join
- Participant is pregnant or planning to become pregnant during the duration of the study
- Participant has a BMI > 30
- Greater than 10% increase or decrease in body weight within past 6 months
- Cellulite treatment on the thighs or buttocks in the last 12 months (Topical or non-invasive procedure)
- Metal or plastic implants in the area of the treatment (vascular stent, or implants in the hips, knees, etc.)
- Active electronic implants such as pacemakers, defibrillators, cochlear implants, nerve/brain stimulators, drug pump, etc.
- Prior liposuction in the thighs or buttocks or any other invasive procedure to limit cellulite.
- Medical disorder that would hinder the wound healing or immune response (no blood disorder, diabetes, inflammatory disease, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
SkinCare Physicians
Chestnut Hill, Massachusetts, 02467
About this study
Official title: Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) Nov Heavy Device for the Treatment of Cellulite
Feasibility study is to evaluate the safety, tolerability and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the treatment of cellulite
Read the detailed description
To assess the safety and tolerability of Soliton's RAP Nov Heavy for the treatment of cellulite. To assess the efficacy of Soliton's RAP Nov Heavy device for the temporary improvement in appearance of cellulite in terms of mean change in cellulite severity score (CSS).
- Conditions
- Cellulite
- Being tested
- Soliton Rapid Acoustic Pulse (RAP)
- Medical subject headings
- Cellulite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soliton Rapid Acoustic Pulse (RAP)Device
Also called RAP
Treatment of legs and/or buttocks for the temporary improvement in the appearance of cellulite.
| Study group | Role | What they receive |
|---|---|---|
| RAP treatment | Other | Single RAP treatment applied to thigh and multi-treatment applied to the other thigh. Receives: Device: Soliton Rapid Acoustic Pulse (RAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of SAEs
The primary safety endpoint will be met if all treated Participants are free from serious adverse events (SAEs) attributable to the RAP device immediately post treatment and at the 3-month follow-up visit.
Measured: 18 weeks
Treatment Tolerability
The primary endpoint will be met if a mean tolerability measure using pain scores averaged across all treated Participants is < 8.0
Measured: 18 Weeks
Secondary outcomes (1)
Cellulite improvement
A ≥15% mean reduction in the 0-5-point Cellulite Severity Scale as determined by physician assessment of Participant photographs taken before and 3 months after treatment.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start31 Jul 2018
- Primary completion5 Aug 2019
- Study completion5 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soliton
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher C Capelli, MD, Study director, Soliton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981198
- Sponsor's protocol ID
- Soliton 2018-001
- Status last verified
- Sep 2021
- First submitted
- 31 May 2019
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) Nov Heavy Device for the Treatment of Cellulite
- ClinicalTrials.gov ID
- NCT03981198
- Acronym / sponsor ID
- Soliton 2018-001
- Conditions
- Cellulite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- SolitonIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 5 Aug 2019 (actual)
- Study completion
- 5 Aug 2019 (actual)
- First posted
- 10 Jun 2019 (actual)
- 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.
Feasibility study is to evaluate the safety, tolerability and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the treatment of cellulite
Detailed description
To assess the safety and tolerability of Soliton's RAP Nov Heavy for the treatment of cellulite. To assess the efficacy of Soliton's RAP Nov Heavy device for the temporary improvement in appearance of cellulite in terms of mean change in cellulite severity score (CSS).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group
| Arm | Type | Receives |
|---|---|---|
| RAP treatment | Other | Device: Soliton Rapid Acoustic Pulse (RAP)Single RAP treatment applied to thigh and multi-treatment applied to the other thigh. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female ages 18-65 years
- Participant seeking treatment of cellulite in the upper lateral thigh areas
- Participant presenting with cellulite Grade I or II on both thighs as graded using the Nurnberger-Muller scale classification (Appendix A)
- Participant has stable weight. Body Mass Index (B.M.I.) is ≤ 30
- Participant will not have any other cellulite treatments for 12 months before and throughout the 3-month follow-up
Key exclusion criteria (8 listed)
- Participant is pregnant or planning to become pregnant during the duration of the study
- Participant has a BMI > 30
- Greater than 10% increase or decrease in body weight within past 6 months
- Cellulite treatment on the thighs or buttocks in the last 12 months (Topical or non-invasive procedure)
- Metal or plastic implants in the area of the treatment (vascular stent, or implants in the hips, knees, etc.)
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 |
|---|---|---|
| Soliton Rapid Acoustic Pulse (RAP)Also: RAPTreatment of legs and/or buttocks for the temporary improvement in the appearance of cellulite. | Device | RAP treatment |
Primary outcome
Incidence of SAEs
Time frame: 18 weeks
The primary safety endpoint will be met if all treated Participants are free from serious adverse events (SAEs) attributable to the RAP device immediately post treatment and at the 3-month follow-up visit.
Treatment Tolerability
Time frame: 18 Weeks
The primary endpoint will be met if a mean tolerability measure using pain scores averaged across all treated Participants is < 8.0
1 secondary outcome
Cellulite improvement
Time frame: 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- 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.
Christopher C Capelli, MD study director
Soliton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soliton Rapid Acoustic Pulse (RAP) in people with Cellulite, run by Soliton 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 8 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 28 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of SAEs (time frame: 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2021.