CompletedNot Applicable

Safety and Efficacy of SofWave Treatment to Lift the Upper Lip and Improve the Peri-Oral Rhytids

United States60 participantsStarted 2023-07-01

Plain-language summary

Open-label, non-randomized, prospective, multi-center, self-controlled

Age range35 Years – 80 Years

SexALL

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 and male subjects between the ages 35-80.
✓. Desire to improve the peri-oral appearance, decrease the distance between the nose and the upper lip (Philtral column length) and/or reduce the peri-oral rhytids.
✓. Philtral column height\>15mm or/and has moderate severe perioral rhytids.
✓. Subject agrees to maintain a stable weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine during the study.
✓. Able and willing to comply with all visits, treatments and evaluation schedules and requirements.
✓. Able to understand and provide written Informed Consent.
✓. Willing to have photographs of the treated areas. Agree for de-identified study images to be used in evaluations, publications and presentations.
✓. Agree not to undergo any other facial treatments for a period of 3 months following SofWave treatments.

✕. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
✕. Current smoker or has history of heavy smoking (25 cigarettes per day or more) in past 10 years.
✕. Melanoma active malignancy or history of malignancy in the past 5 years.
✕. Any other non-melanoma malignancy active malignancy or history of malignancy in the past 5 years within the intended to treat area.
✕. Previous chemotherapy treatments.
✕. Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders (i.e. any disease state that in the opinion of the investigator may interfere with the anesthesia, treatment, or healing process).
✕. History of chronic drug or alcohol abuse
✕. History of Epileptic seizures.

Rate of improvement in the appearance of upper lip and peri-oral rhytids

Timeframe: 12 weeks post last treatment

NCT IDNCT06104514

SponsorSofwave Medical LTD

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-12

Who can participate

Age range35 Years – 80 Years

SexALL

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 and male subjects between the ages 35-80.
✓. Desire to improve the peri-oral appearance, decrease the distance between the nose and the upper lip (Philtral column length) and/or reduce the peri-oral rhytids.
✓. Philtral column height\>15mm or/and has moderate severe perioral rhytids.
✓. Subject agrees to maintain a stable weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine during the study.
✓. Able and willing to comply with all visits, treatments and evaluation schedules and requirements.
✓. Able to understand and provide written Informed Consent.
✓. Willing to have photographs of the treated areas. Agree for de-identified study images to be used in evaluations, publications and presentations.
✓. Agree not to undergo any other facial treatments for a period of 3 months following SofWave treatments.

✕. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
✕. Current smoker or has history of heavy smoking (25 cigarettes per day or more) in past 10 years.
✕. Melanoma active malignancy or history of malignancy in the past 5 years.
✕. Any other non-melanoma malignancy active malignancy or history of malignancy in the past 5 years within the intended to treat area.
✕. Previous chemotherapy treatments.
✕. Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders (i.e. any disease state that in the opinion of the investigator may interfere with the anesthesia, treatment, or healing process).
✕. History of chronic drug or alcohol abuse
✕. History of Epileptic seizures.