Safety and Efficacy of SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow

NCT04146584 | Completed Phase 2 FDA Device

• 1 other identifier: Sofwave04
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 5

Brief Summary

This is a prospective, open label, multi-center, self-controlled clinical study to demonstrate the safety and efficacy of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow.

Conditions

Skin Laxity; Wrinkle; Brow Lifting

Keywords

Skin Laxity; Submental; Neck; Brow Lifting; Laxity; Saggy

Outcome Measures

Primary Outcomes (2)

• Efficacy Masked Evaluators Evaluations: assessed by independent masked evaluators

  Evaluate the clinical efficacy of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow, as assessed by independent masked evaluators. The two independent masked evaluators would be delivered a presentation with images randomly ordered for 'before' and 'after'. Each investigator would have to guess the correct 'after' image. Both investigators must agree on more than 50% of the cases to match success criteria. Each treated zone (Eyebrows, Neck \& Submental) would be ranked individually. The primary endpoint would only be achieved along with success in outcome #5.

  3 months post last treatment follow up visit

• Safety Investigator Assessments

  Evaluate the clinical safety of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow, as assessed by study physician. The investigator would examine the patient's skin before and after treatments and on follow up visits and would be requested to fill in a physician assessment, ranking Edema, erythema, ulceration/erosion, hypopigmentation and hyperpigmentation on a 5 option scale ranging from 0. - Absent to 4. Prominent. Safety would be checked every visit.

  3 months post last treatment follow up visit

Secondary Outcomes (2)

• Efficacy Investigator Assessments

  On the second treatment visit date (pre treatment), 3 months post last treatment follow up visit

• Subject Efficacy Assessments

  On the second treatment visit date (pre treatment), 3 months post last treatment follow up visit

Other Outcomes (1)

• Quantitative Photo Analysis

  3 months post last follow up visit

Study Arms (1)

Sofwave Treatment

EXPERIMENTAL

In this arm (single) patients would be treated twice with Sofwave on the face and/or submental and neck.

Device: Sofwave Treatments

Interventions

Sofwave Treatments DEVICE

The device used in this study will be the SofWave system manufactured by SofWave Medical ltd. The SofWave device is an ultrasonic system combined with an inherent cooling system that generates High Intensity non-focused Ultrasonic pulses (HIUS), causing a controlled thermal damage by elevating the temperature to 60-70°C in the dermis layer while sparing the epidermal layer using surface cooling. Each patient would receive 2 Sofwave treatments on the face and/or the neck.

Sofwave Treatment

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy female and male subjects between the ages 35-80.
• Non-Smoker.
• Fitzpatrick skin type I-VI.
• Desire to lift lax skin in the neck and submental and/or to lift the brows.
• Able and willing to comply with all visit, treatment and evaluation schedules and requirements.
• Able to understand and provide written Informed Consent
• Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment.

You may not qualify if:

• Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
• Presence of any active systemic or local infections.
• Presence of active local skin disease that may alter wound healing.
• Severe solar elastosis.
• History of Epileptic seizures.
• History of severe migraine tendency.
• History of smoking in past 10 years.
• History of chronic drug or alcohol abuse.
• Excessive subcutaneous fat on the cheeks.
• Significant scarring in the area to be treated.
• Severe or cystic facial acne, acutance uses during past 6 months.
• Presence of a metal stent or implant in the facial area.
• Inability to understand the protocol or to give informed consent.
• On-going use of psychiatric medication.
• History of cosmetic treatments in the facial area to be treated, including facial skin-tightening procedure within the past year; injectable filler of any type within the past year; Botox or fillers in the lower face 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.

Sponsors & Collaborators

• Sofwave Medical LTD: lead

Study Sites (5)

Laser & Skin Surgery Center of Northern California

Sacramento, California, 95816, United States

Location

Laser & Skin Surgery Center of New York®

New York, New York, 10016, United States

Location

New York Laser & Skin Care

New York, New York, 10028, United States

Location

Dermatology, Laser & Vein Specialists of the Carolinas

Charlotte, North Carolina, 28207, United States

Location

Dermatology & Laser Surgery Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Avishai Tzur

  Clinical Projects Manager

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 31, 2019
• Study Start: November 20, 2019
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: July 22, 2021

Record last verified: 2021-07

Locations

US (5)