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Status:

COMPLETED

Safety and Efficacy of Sofwave Treatment to Lift Lax Skin

Lead Sponsor:

Sofwave Medical LTD

Conditions:

Skin Laxity

Eligibility:

All Genders

35-80 years

Phase:

PHASE3

Brief Summary

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

Detailed 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 we...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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 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 (dental implants and/or braces are not excluded).
  • Inability to understand the protocol or to give informed consent.
  • 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.
  • 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.

Key Trial Info

Start Date :

January 10 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 31 2021

Estimated Enrollment :

45 Patients enrolled

Trial Details

Trial ID

NCT04829227

Start Date

January 10 2020

End Date

December 31 2021

Last Update

October 26 2022

Active Locations (4)

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Page 1 of 1 (4 locations)

1

SLSS, a Division of Schweiger Dermatology Group Research Office

Hackensack, New Jersey, United States, 07601

2

The Practice of Brian S. Biesman, MD

Nashville, Tennessee, United States, 37203

3

Tennessee Clinical Research Center

Nashville, Tennessee, United States, 37215

4

McDaniel Institute of Aging Research

Virginia Beach, Virginia, United States, 23462