CompletedNot Applicable

Safety and Efficacy of Sofwave Treatment for Acne Scars Appearance Improvement

United States60 participantsStarted 2022-02-01

Plain-language summary

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

Age range22 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 male or female subjects \> 22 years of age and \< 80 years of age.
✓. For female subjects, 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.
✓. Seeking treatment for facial acne scars.
✓. Have visible mild to moderate facial acne scars.
✓. Agree not to undergo any other facial acne scars treatments for a period of 3 months following Sofwave treatments.
✓. Willing to have photographs of the treated areas. Agree for de-identified study images to be used in evaluations, publications and presentations.
✓. Able and willing to comply with all visits, treatments and evaluations schedules and requirements.
✓. Able to understand and provide written Informed Consent

✕. Pregnant or planning to become pregnant during the duration of the study, 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.
✕. History of severe migraine tendency.
✕. History of Epileptic seizures.
✕. History of chronic drug or alcohol abuse.
✕. Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant within the past 2 weeks.
✕. Medical disorder that may hinder the wound healing or immune response (such as blood disorder, inflammatory disease, etc.)
✕. Presence of a metal stent or implant in the facial area.

Rate of change of acne scars appearance, as assessed by independent masked evaluators at 3 months post last treatment session.

Timeframe: 1 year

NCT IDNCT05358860

SponsorSofwave Medical LTD

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-31

Who can participate

Age range22 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 male or female subjects \> 22 years of age and \< 80 years of age.
✓. For female subjects, 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.
✓. Seeking treatment for facial acne scars.
✓. Have visible mild to moderate facial acne scars.
✓. Agree not to undergo any other facial acne scars treatments for a period of 3 months following Sofwave treatments.
✓. Willing to have photographs of the treated areas. Agree for de-identified study images to be used in evaluations, publications and presentations.
✓. Able and willing to comply with all visits, treatments and evaluations schedules and requirements.
✓. Able to understand and provide written Informed Consent

✕. Pregnant or planning to become pregnant during the duration of the study, 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.
✕. History of severe migraine tendency.
✕. History of Epileptic seizures.
✕. History of chronic drug or alcohol abuse.
✕. Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant within the past 2 weeks.
✕. Medical disorder that may hinder the wound healing or immune response (such as blood disorder, inflammatory disease, etc.)
✕. Presence of a metal stent or implant in the facial area.