Sofwave for Cellulite

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Laser & Skin Surgery Center of New York®, New York, NY
Cellulite+1 More
Sofwave - Device
Eligibility
18 - 65
Female
What conditions do you have?
Select

Study Summary

This trial is evaluating an experimental medication to see if it is safe and effective. People enrolled will take the medication and be monitored for side effects and how well it works. Sofwave is a treatment for Cellulite that has been previously approved by the FDA for a different condition. There will be no placebo group in this trial.

Eligible Conditions

  • Cellulite

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Cellulite

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 3 months post treatment follow-up visit.

Month 3
Rate of improvement in the appearance of cellulite on the upper thigh/buttock area

Trial Safety

Safety Progress

1 of 3

Other trials for Cellulite

Trial Design

1 Treatment Group

Cellulite
1 of 1
Experimental Treatment

60 Total Participants · 1 Treatment Group

Primary Treatment: Sofwave · No Placebo Group · N/A

Cellulite
Device
Experimental Group · 1 Intervention: Sofwave · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months post treatment follow-up visit.
Closest Location: Laser & Skin Surgery Center of New York® · New York, NY
Photo of New York 1Photo of New York 2Photo of New York 3
2021First Recorded Clinical Trial
1 TrialsResearching Cellulite
1 CompletedClinical Trials

Who is running the clinical trial?

Sofwave Medical LTDLead Sponsor
6 Previous Clinical Trials
378 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · Female Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have visible cellulite in the upper thigh and/or buttock areas.
You are seeking treatment for cellulite in the upper thigh and/or buttock areas.
You are stable weight for at least 6 months.
You are not currently using topical based cellulite treatments for your skin condition.
Subject agrees not to undergo any other treatments for a period of 6 months following Sofwave treatment.
You are a healthy female subject aged 18 years or older and not 60 years or older.
You are 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.
You agree to maintain your weight by not making any major changes in your diet or exercise routine during the study course.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.