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出境医 / 临床实验 / Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) for the Treatment of Cellulite
Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) for the Treatment of Cellulite
Study Description
Brief Summary:
Feasibility study is to evaluate the safety, tolerability and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the treatment of cellulite
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cellulite | Device: Soliton Rapid Acoustic Pulse (RAP) | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 5 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Single Group |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) Nov Heavy Device for the Treatment of Cellulite |
| Actual Study Start Date : | July 31, 2018 |
| Actual Primary Completion Date : | August 5, 2019 |
| Actual Study Completion Date : | August 5, 2019 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
RAP treatment
Single RAP treatment applied to thigh and multi-treatment applied to the other thigh.
|
Device: Soliton Rapid Acoustic Pulse (RAP)
Treatment of legs and/or buttocks for the temporary improvement in the appearance of cellulite.
Other Name: RAP
|
Outcome Measures
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- Celluite improvement [ Time Frame: 18 weeks ]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.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.)
Contacts and Locations
Locations
| United States, Massachusetts | |
| SkinCare Physicians | |
| Chestnut Hill, Massachusetts, United States, 02467 | |
Sponsors and Collaborators
Soliton
Investigators
| Study Director: | Christopher C Capelli, MD | Soliton |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 31, 2019 | ||||||||
| First Posted Date ICMJE | June 10, 2019 | ||||||||
| Last Update Posted Date | July 13, 2020 | ||||||||
| Actual Study Start Date ICMJE | July 31, 2018 | ||||||||
| Actual Primary Completion Date | August 5, 2019 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
|
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| Original Primary Outcome Measures ICMJE |
Safety [ Time Frame: 18 weeks ] Evaluate for adverse events attributable to the RAP device.
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
Celluite improvement [ Time Frame: 18 weeks ] 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.
|
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| Original Secondary Outcome Measures ICMJE |
Efficacy [ Time Frame: 18 ] To evaluate the reductions of cellulite. Achievement is measured by ≥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.
|
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) for the Treatment of Cellulite | ||||||||
| Official Title ICMJE | Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) Nov Heavy Device for the Treatment of Cellulite | ||||||||
| Brief Summary | 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 Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Single Group Masking: None (Open Label)Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Cellulite | ||||||||
| Intervention ICMJE | Device: Soliton Rapid Acoustic Pulse (RAP)
Treatment of legs and/or buttocks for the temporary improvement in the appearance of cellulite.
Other Name: RAP
|
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| Study Arms ICMJE | RAP treatment
Single RAP treatment applied to thigh and multi-treatment applied to the other thigh.
Intervention: Device: Soliton Rapid Acoustic Pulse (RAP)
|
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Actual Enrollment ICMJE |
5 | ||||||||
| Original Actual Enrollment ICMJE | Same as current | ||||||||
| Actual Study Completion Date ICMJE | August 5, 2019 | ||||||||
| Actual Primary Completion Date | August 5, 2019 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03981198 | ||||||||
| Other Study ID Numbers ICMJE | Soliton 2018-001 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Soliton | ||||||||
| Study Sponsor ICMJE | Soliton | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Soliton | ||||||||
| Verification Date | July 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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