Active — Not RecruitingNot Applicable

Combined Treatment Sofwave and Pure Impact to Strength and Tone Muscles and Improve Lax Skin Appearance

United States70 participantsStarted 2024-08-05

Plain-language summary

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

Age range25 Years – 70 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.

✓. Male or female subjects ≥ 25 years of age and ≤ 70 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.
✓. Desire to undergo treatments on upper arms for skin lax and for strength and tone muscles.
✓. Subject has clearly visible lax skin on the upper arm, which in the investigator's opinion, may benefit from the treatment.
✓. Subject agrees to maintain his/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.
✓. Able and willing to comply with all visits, treatments and evaluations schedules and requirements.
✓. Willing to have research photos taken of treatment areas.
✓. Subject agrees not to undergo any other upper arm skin lax treatments for a period of 3 months following SofWave and Pure Impact treatments.

✕. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
✕. Skin disorders (skin infections or rashes, extensive scarring, psoriasis, open wounds etc.) in the treatment area.
✕. Medical disorder that would hinder the wound healing or immune response (such as blood disorder) including but not limited to arterial circulation disorders in lower limbs, inflammatory disease, etc.
✕. Known allergy to lidocaine or epinephrine.
✕. Active malignancy or history of malignancy in the past 5 years.
✕. Suffering from significant concurrent illness, such as cardiac disorders, sensory disturbances, diabetes (type I or II), epilepsy, lupus, porphyria, pertinent neurological disorders, uncontrolled hypertension, or liver or kidney disease (i.e. any disease state that in the opinion of the investigator may interfere with the anesthesia, treatment, or healing process).
✕. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
✕. Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen.

Improvement in the appearance of lax skin

Timeframe: 3 months post treatment follow-up visit

NCT IDNCT06724146

SponsorSofwave Medical LTD

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10-01

Who can participate

Age range25 Years – 70 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.

✓. Male or female subjects ≥ 25 years of age and ≤ 70 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.
✓. Desire to undergo treatments on upper arms for skin lax and for strength and tone muscles.
✓. Subject has clearly visible lax skin on the upper arm, which in the investigator's opinion, may benefit from the treatment.
✓. Subject agrees to maintain his/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.
✓. Able and willing to comply with all visits, treatments and evaluations schedules and requirements.
✓. Willing to have research photos taken of treatment areas.
✓. Subject agrees not to undergo any other upper arm skin lax treatments for a period of 3 months following SofWave and Pure Impact treatments.

✕. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
✕. Skin disorders (skin infections or rashes, extensive scarring, psoriasis, open wounds etc.) in the treatment area.
✕. Medical disorder that would hinder the wound healing or immune response (such as blood disorder) including but not limited to arterial circulation disorders in lower limbs, inflammatory disease, etc.
✕. Known allergy to lidocaine or epinephrine.
✕. Active malignancy or history of malignancy in the past 5 years.
✕. Suffering from significant concurrent illness, such as cardiac disorders, sensory disturbances, diabetes (type I or II), epilepsy, lupus, porphyria, pertinent neurological disorders, uncontrolled hypertension, or liver or kidney disease (i.e. any disease state that in the opinion of the investigator may interfere with the anesthesia, treatment, or healing process).
✕. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
✕. Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen.