Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators

Launched by SOFWAVE MEDICAL LTD · Mar 20, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment designed to lift loose skin on the face, neck, and around the eyebrows, as well as to reduce the appearance of facial wrinkles. The study aims to find out how effective this treatment is for people who want to improve their skin’s tightness and overall look. The trial is currently recruiting participants who are healthy men and women aged between 35 and 80, who do not smoke and have a specific skin type. Participants should have a desire to enhance their facial appearance and must be willing to follow all study requirements, including attending scheduled visits and treatments.

If you decide to join the trial, you can expect to undergo the treatment and have your results evaluated by trained professionals. It's important to note that women who can become pregnant must use reliable birth control during the study, and participants will need to avoid any other facial cosmetic treatments for three months after the last treatment in the study. This trial is a great opportunity for those looking to improve their skin without undergoing surgery, but it is essential to meet certain criteria to ensure your safety and the study's success.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy female and male subjects between the ages 35-80.
• • 2. Non-Smoker.
• • 3. Fitzpatrick skin type I-VI.
• • 4. Desire to lift facial lax skin, neck and/or submental and/or to lift the eyebrow area and/or improve facial wrinkles appearance.
• • 5. Able and willing to comply with all visits, treatments and evaluation schedules and requirements.
• • 6. Able to understand and provide written Informed Consent.
• • 7. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment.
• • 8. Subject agrees not to undergo any other facial cosmetic treatment for a period of 3 months following last SofWave treatment.
• • 9. Stable weight over the last 12 weeks and throughout the duration of the study.
• Exclusion Criteria:
• • 1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
• • 2. Presence of any active systemic or local infections.
• • 3. Presence of active local skin disease that may alter wound healing.
• • 4. Severe solar elastosis.
• • 5. Currently a smoker or has a history of heavy smoking (25 cigarettes per day or more) in the past 10 years.
• • 6. History of chronic drug or alcohol abuse.
• • 7. Excessive subcutaneous fat on the cheeks.
• • 8. Significant scarring in the area to be treated.
• • 9. Severe or cystic facial acne, and/or Accutane use during past 6 months.
• • 10. Presence of a metal stent or implant in the facial area (dental implants and/or braces are not excluded).
• • 11. Inability to understand the protocol or to provide a signed informed consent.
• • 12. History of cosmetic treatments in the facial area to be treated, including facial skin-tightening procedure within the past 6 months; injectable (Botox or fillers) of any type within the past 6 months; ablative or non-ablative resurfacing/rejuvenation laser treatment or light treatment within the past 6 months, dermabrasion or deep facial peels within the past 12 months; facelift, blepharoplasty, or brow lift (including contour threads) within the past 12 months.
• • 13. Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant within the past 2 weeks.
• • 14. As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.