CompletedNot Applicable

Treatment for Improvement of Cellulite Appearance Using Form Applicator

United States60 participantsStarted 2023-02-20

Plain-language summary

Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with masked evaluation.

Age range18 Years – 60 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Healthy female subjects \> 18 years of age and \< 60 years of age
✓. 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.
✓. Have visible cellulite in the upper thigh and/or buttock areas.
✓. Seeking treatment of cellulite in the upper thigh and/or buttock areas.
✓. Stable weight nominally ±5% for at least past 6 months
✓. Subject agrees to maintain her weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine during the study course.
✓. Subject did not undergo invasive or energy-based cellulite treatments (liposuction, subcision, RF, laser, ESWT, etc.) for the prior 12 months.
✓. Subject did not use topical based cellulite treatments for prior 6 months and will not use during the trial (except for the study related procedures)

✕. Pregnant or planning to become pregnant during the duration of the study, having given birth less than 3 months ago, and/or breast feeding
✕. Currently heavy smoker or has history of heavy smoking (25 cigarettes per day or more) in past 10 years
✕. BMI\>=30kg/m2
✕. Non-stable weight nominally ±5% for at least past 6 months
✕. Currently taking or has taken diet pills or weight control supplements within the past month
✕. History of severe migraine tendency
✕. History of Epileptic seizures
✕. History of chronic drug or alcohol abuse

Primary Outcome Measure:

Timeframe: 3 months post treatment follow-up visit

NCT IDNCT05882721

SponsorSofwave Medical LTD

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-01

Who can participate

Age range18 Years – 60 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Healthy female subjects \> 18 years of age and \< 60 years of age
✓. 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.
✓. Have visible cellulite in the upper thigh and/or buttock areas.
✓. Seeking treatment of cellulite in the upper thigh and/or buttock areas.
✓. Stable weight nominally ±5% for at least past 6 months
✓. Subject agrees to maintain her weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine during the study course.
✓. Subject did not undergo invasive or energy-based cellulite treatments (liposuction, subcision, RF, laser, ESWT, etc.) for the prior 12 months.
✓. Subject did not use topical based cellulite treatments for prior 6 months and will not use during the trial (except for the study related procedures)

✕. Pregnant or planning to become pregnant during the duration of the study, having given birth less than 3 months ago, and/or breast feeding
✕. Currently heavy smoker or has history of heavy smoking (25 cigarettes per day or more) in past 10 years
✕. BMI\>=30kg/m2
✕. Non-stable weight nominally ±5% for at least past 6 months
✕. Currently taking or has taken diet pills or weight control supplements within the past month
✕. History of severe migraine tendency
✕. History of Epileptic seizures
✕. History of chronic drug or alcohol abuse