NCT06333067

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

March 20, 2024

Last Update Submit

May 12, 2025

Conditions

Lax Skin

Keywords

neck zones.submentalFacialSkin laxity

Outcome Measures

Primary Outcomes (1)

  • Improvement in the appearance of lax skin

    Rate of improvement in the appearance of lax skin on the submental, neck zones and facial wrinkles following Sofwave treatments based on Global Aesthetic Improvement Scale, as evaluated by independent masked reviewers.

    3 months post treatment follow-up visit

Study Arms (1)

lax tissue

EXPERIMENTAL
Device: Sofwave

Interventions

SofwaveDEVICE

The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues.

Also known as: SUPERB
lax tissue

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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 facial lax skin, neck and/or submental and/or to lift the eyebrow area and/or improve facial wrinkles appearance.
  • Able and willing to comply with all visits, treatments 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.
  • Subject agrees not to undergo any other facial cosmetic treatment for a period of 3 months following last SofWave treatment.
  • Stable weight over the last 12 weeks and throughout the duration of the study.

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.
  • \. Currently a smoker or has a history of heavy smoking (25 cigarettes per day or more) in the 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, and/or Accutane use during past 6 months.
  • \. Presence of a metal stent or implant in the facial area (dental implants and/or braces are not excluded).
  • \. Inability to understand the protocol or to provide a signed informed consent.
  • \. 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.
  • \. Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant within the past 2 weeks.
  • \. As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Costal Skin & Eye Institute

La Mesa, California, 91942, United States

RECRUITING

Skin Wellness Dermatology Associates

Durham, North Carolina, 27713, United States

RECRUITING

MeSH Terms

Conditions

Cutis LaxaFacies

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Shlomit Mann, MSc

CONTACT

+972-4-7800268Shlomit@sofwave.com

Ruthie Amir, MD

CONTACT

+972-4-300-3164Ruthie@sofwave.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2024

First Posted

March 27, 2024

Study Start

October 11, 2023

Primary Completion

October 1, 2025

Study Completion

November 1, 2025

Last Updated

May 13, 2025

Record last verified: 2025-05

Locations

US(2)