CelluliteNCT04065711
Study of the Soliton Rapid Acoustic Pulse (RAP) Device for the Treatment of Cellulite
A study testing Soliton's Rapid Acoustic Pulse (RAP) in people with Cellulite, run by Soliton at 4 sites in United States.
Trial summary
To evaluate the safety, and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the temporary improvement in the appearance of cellulite. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cellulite
- What is being tested?
- Soliton's Rapid Acoustic Pulse (RAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Jul 2019to 26 Aug 2021
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female ages 18-50 years
- Seeking treatment of cellulite in the thigh and/or buttock areas
- Area of severe cellulite on the thigh and/or buttock with an average simplified Cellulite Severity Scale at Baseline ≥ 4.0 (Table 2)
- Having at least one dimple, or ridge-depression, in the treatment area, with a depth of approximately 5 mm or greater.
- Stable weight nominally +/- 5% for at least the past 6 months.
- Body Mass Index (B.M.I.) is ≤ 30
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- Participant will not have had invasive or energy based cellulite treatments (liposuction, subcision, RF, laser, ESWT, etc.) for the prior 12 months.
- Participant will not have used topical based cellulite treatments for prior 6 months and will not use during the trial.
- Will not undergo any other cellulite treatments for a period of 12 months following RAP treatment.
- Participant is willing to participate in study and adhere to follow-up schedule
- Participant is able to read and comprehend English
- Participant has completed the Informed Consent Form
Who cannot join
- Participant is unwilling to have research photos taken of treatment areas in the presence of Sponsor's researchers.
- Participant is unwilling to have RAP treatment provided in the presence of Sponsor's researchers.
- Participant is pregnant or planning to become pregnant during the duration of the study.
- Has atrophic scars, or has a history of atrophic scars or keloids.
- Tattoo or former tattoo at or near treatment area.
- Metal or plastic implants in the area of the treatment (vascular stent, or implants in the hips, knees, etc.).
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- Active electronic implants such as pacemakers, defibrillators, cochlear implants, nerve/brain stimulators, drug pump, etc.
- Medical disorder that would hinder the wound healing or immune response (no blood disorder, inflammatory disease, etc.).
- History of coagulopathy(ies) and/or on anticoagulant medication.
- Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area.
- Current smoker.
- Any surgical procedure in the prior 3 months, or planned during the duration of the study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
SkinCare Physicians
Chestnut Hill, Massachusetts, 02467
Capital Laser and Skin Care
Chevy Chase, Maryland, 20815
Chicago Cosmetic Surgery & Dermatology
Chicago, Illinois, 60654
Clear Dermatology and Aesthetics Center Investigate MD
Scottsdale, Arizona, 85255
About this study
Official title: Multi-Center Study of the Soliton Rapid Acoustic Pulse (RAP) Device for the Treatment of Cellulite
To evaluate the safety, and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the temporary improvement in the appearance of cellulite.
Read the detailed description
Multi-site clinical study to evaluate the safety, efficacy and tolerability of Soliton's Rapid Acoustic Pulse (RAP) device fo the temporary improvement in the appearance of cellulite.
- Conditions
- Cellulite
- Being tested
- Soliton's 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's Rapid Acoustic Pulse (RAP)Device
Treatment for the temporary improvement in the appearance of cellulite.
| Study group | Role | What they receive |
|---|---|---|
| RAP Treatment | Experimental | Each treatment area will receive 30-40 minutes (30-40 individual doses) of RAP treatment. Receives: Device: Soliton's Rapid Acoustic Pulse (RAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure Safety- All treated participants are free from unexpected adverse events
The primary objective is to demonstrate freedom from unexpected adverse
events (UAEs) and serious adverse events (SAEs) directly attributable to the RAP device or treatment.
Measured: 12 weeks
Secondary outcomes (1)
RAP treatment effectiveness
To demonstrate temporary improvement in the appearance of cellulite as determined by blinded independent physician assessment (IPA) correctly identifying the 12-week post-treatment photographs from randomly placed side-by-side comparison of before and after photographs.
Measured: 12 weeks, 26 weeks and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start20 Jul 2019
- Primary completion20 Jul 2021
- Study completion26 Aug 2021
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soliton
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Capelli, MD, Study director, Soliton, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065711
- Sponsor's protocol ID
- 2019-002
- Status last verified
- Sep 2021
- First submitted
- 20 Aug 2019
- Last updated
- 22 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 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Study of the Soliton Rapid Acoustic Pulse (RAP) Device for the Treatment of Cellulite
- ClinicalTrials.gov ID
- NCT04065711
- Acronym / sponsor ID
- 2019-002
- Conditions
- Cellulite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- SolitonIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2019 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 26 Aug 2021 (actual)
- First posted
- 22 Aug 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.
To evaluate the safety, and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the temporary improvement in the appearance of cellulite.
Detailed description
Multi-site clinical study to evaluate the safety, efficacy and tolerability of Soliton's Rapid Acoustic Pulse (RAP) device fo the temporary improvement in the appearance of cellulite.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAP Treatment | Experimental | Device: Soliton's Rapid Acoustic Pulse (RAP)Each treatment area will receive 30-40 minutes (30-40 individual doses) of RAP treatment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Female ages 18-50 years
- Seeking treatment of cellulite in the thigh and/or buttock areas
- Area of severe cellulite on the thigh and/or buttock with an average simplified Cellulite Severity Scale at Baseline ≥ 4.0 (Table 2)
- Having at least one dimple, or ridge-depression, in the treatment area, with a depth of approximately 5 mm or greater.
- Stable weight nominally +/- 5% for at least the past 6 months.
Key exclusion criteria (12 listed)
- Participant is unwilling to have research photos taken of treatment areas in the presence of Sponsor's researchers.
- Participant is unwilling to have RAP treatment provided in the presence of Sponsor's researchers.
- Participant is pregnant or planning to become pregnant during the duration of the study.
- Has atrophic scars, or has a history of atrophic scars or keloids.
- Tattoo or former tattoo at or near treatment area.
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's Rapid Acoustic Pulse (RAP)Treatment for the temporary improvement in the appearance of cellulite. | Device | RAP Treatment |
Primary outcome
Procedure Safety- All treated participants are free from unexpected adverse events
Time frame: 12 weeks
The primary objective is to demonstrate freedom from unexpected adverse events (UAEs) and serious adverse events (SAEs) directly attributable to the RAP device or treatment.
1 secondary outcome
RAP treatment effectiveness
Time frame: 12 weeks, 26 weeks and 52 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 22 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 Capelli, MD study director
Soliton, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soliton's Rapid Acoustic Pulse (RAP) in people with Cellulite, run by Soliton 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 12 inclusion and 12 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 22 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 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?
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?
Procedure Safety- All treated participants are free from unexpected adverse events (time frame: 12 weeks). 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 22 Sep 2021.