Safety and Efficacy of Sofwave Treatment to Lift Lax Skin

Sofwave Medical

Status and phase: Completed; Phase 3

Conditions: Skin Laxity

Treatments: Device: Sofwave

Study type: Interventional

Funder types: Industry

Identifiers

NCT04829227

Sofwave05

Details and patient eligibility

About

Open-label, non-randomized 2 arms prospective, multi-center, self-controlled clinical study with masked evaluation.

Full description

This study is a two-arm study. Eligible patients will receive 2-4 face and/or neck and/or submental or "off the face" (abdomen, or arms, or thighs, or Décolleté) treatments (per PI discretion, 2-12 weeks apart) using the Sofwave System. In arm 1, each investigational site would treat the full face and/or neck and/or submental zones including 1. -The forehead and temples (left and right including the peri orbital zone) to lift the eyebrows 2. The cheeks (left and right including perioral zone and nasolabial folds) 3. Submental and sides of the neck (left and right) to lift lax skin. In arm 2, each site would treat "off the face" areas: abdomen, or arms or thighs or Décolleté. Each patient could be assigned to both arms. Treatment may be administered after the enrollment and screening at the first visit or it may occur at a later date following the enrollment and screening activities based on site scheduling availabilities. All patients will return to the clinic for one follow up visitat3 months ± 2 weeks post last treatment (FU1) and a second optional visit at 2. 6 months ± 2 weeks post last treatment (FU2; optional). Each treatment visit will also serve as a follow up.

Enrollment: 45 patients

Sex: All

Ages: 35 to 80 years old

Volunteers: Accepts Healthy Volunteers

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 lax skin in the neck and submental and/or to lift the brows.
5. Able and willing to comply with all visit, treatment 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.

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. History of smoking in 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, acutance uses 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 give informed consent.
12. History of cosmetic treatments in the facial area to be treated, including facial skin-tightening procedure within the 6 months ; injectable (Botox or fillers) of any type within the 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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45 participants in 2 patient groups

face and/or neck and/or submental zones

Experimental group

Description:

the full face and/or neck and/or submental zones including 1. -The forehead and temples (left and right including the peri orbital zone) to lift the eyebrows 2. The cheeks (left and right including perioral zone and nasolabial folds) 3. Submental and sides of the neck

Treatment:

Device: Sofwave

"off the face" areas

Experimental group

Description:

"off the face" areas: abdomen, or arms or thighs or Décolleté.

Treatment:

Device: Sofwave