Treatment for lifting lax facial skin and reducing wrinkles

Safety and Efficacy of SofWave Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators

This study is testing a new treatment using the SofWave system to see if it can help tighten loose facial skin and reduce wrinkles for people looking for cosmetic improvements.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 35 Years to 80 Years
• Sex: All
• Sponsor: Sofwave Medical LTD (Industry-sponsored)
• Locations: 2 sites (La Mesa, California and 1 other locations)
• Trial ID: NCT06333067 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of the SofWave system using Lift and Precise applicators to treat lax skin and improve facial wrinkles. Eligible participants will receive 1-2 treatments on their face, neck, or submental areas, spaced 2-12 weeks apart, based on the discretion of the principal investigator. The study is open-label and non-randomized, with a follow-up visit scheduled 3 months after the last treatment to assess safety and efficacy. Participants will be monitored throughout the study to ensure compliance with treatment and evaluation schedules.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 35-80 who desire to improve the appearance of lax facial skin and wrinkles.

Not a fit: Patients who are pregnant, breastfeeding, or have active skin diseases or infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly enhance the appearance of facial skin by reducing laxity and wrinkles.

How similar studies have performed: Other studies using similar non-invasive skin treatment technologies have shown promising results, indicating potential for success in this approach.

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.

Where this trial is running

La Mesa, California and 1 other locations

• Costal Skin & Eye Institute — La Mesa, California, United States (Recruiting)
• Skin Wellness Dermatology Associates — Durham, North Carolina, United States (Recruiting)

Study contacts

• Study coordinator: Shlomit Mann, MSc

Conditions Lax Skin; neck zones.; submental; Facial; Skin laxity