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

Sponsor
Sofwave Medical LTD (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04969380
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Sofwave
 Phase 3

Detailed Description

Eligible patients will receive 2 face and neck treatments (4-6 weeks ± 2 weeks apart) using the SofWave System. Each investigational site would treat the full face and 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.

All patients will return to the clinic for two follow up visits: 1. 7 days (FU1) post the first treatment (Tx.1). 2. 3 months ± 2 weeks post last treatment (FU2).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety and Efficacy of Sofacia Treatment to Improve Facial Lines and Wrinkles, to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow
Actual Study Start Date :
Feb 27, 2020
Anticipated Primary Completion Date :
Feb 27, 2022
Anticipated Study Completion Date :
Feb 27, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: face and/or neck and/or submental zones

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

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

Outcome Measures

Primary Outcome Measures

  1. Change in lift of lax tissue [3 and 6 months post last treatment]

    As assessed by independent masked evaluators. Quantitative image analysis to objectively measure change in lift of the eyebrow and submental and neck lax tissue would be conducted by comparing baseline images to those taken at each visit post FU1 (Pre Tx.2, FU2)

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California Irvine California United States 92697

Sponsors and Collaborators

  • Sofwave Medical LTD

Investigators

  • Study Director: Ruthie Amir, MD, Sofwave

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sofwave Medical LTD
ClinicalTrials.gov Identifier:
NCT04969380
Other Study ID Numbers:
  • UCI IRB HS# 2019-5520
First Posted:
Jul 20, 2021
Last Update Posted:
Oct 15, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Sofwave Medical LTD
Laxity Brow Lifting Skin Saggy
Additional relevant MeSH terms:
Cutis Laxa

Study Results

No Results Posted as of Oct 15, 2021