RECRUITING

Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators

Conditions

Lax Skin neck zones.submental Facial Skin laxity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Safety and Efficacy of SofWave Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators

Quick Facts

Study Start:2023-10-11

Study Completion:2025-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06333067

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:35 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 facial lax skin, neck and/or submental and/or to lift the eyebrow area and/or improve facial wrinkles appearance. 5. Able and willing to comply with all visits, treatments 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. 8. Subject agrees not to undergo any other facial cosmetic treatment for a period of 3 months following last SofWave treatment. 9. Stable weight over the last 12 weeks and throughout the duration of the study.	* 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. Currently a smoker or has a history of heavy smoking (25 cigarettes per day or more) in the 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, and/or Accutane use 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 provide a signed informed consent. 12. 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. 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.

Inclusion Criteria

Exclusion 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 facial lax skin, neck and/or submental and/or to lift the eyebrow area and/or improve facial wrinkles appearance.
5. Able and willing to comply with all visits, treatments 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.
8. Subject agrees not to undergo any other facial cosmetic treatment for a period of 3 months following last SofWave treatment.
9. Stable weight over the last 12 weeks and throughout the duration of the study.

* 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. Currently a smoker or has a history of heavy smoking (25 cigarettes per day or more) in the 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, and/or Accutane use 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 provide a signed informed consent.
12. 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.
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

Study Contact

Shlomit Mann, MSc

CONTACT

+972-4-7800268

Shlomit@sofwave.com

Ruthie Amir, MD

CONTACT

+972-4-300-3164

Ruthie@sofwave.com

Study Locations (Sites)

Costal Skin & Eye Institute

La Mesa, California, 91942

United States

Skin Wellness Dermatology Associates

Durham, North Carolina, 27713

United States

Collaborators and Investigators

Sponsor: Sofwave Medical LTD

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-11

Study Completion Date2025-11-01

Study Record Updates

Study Start Date2023-10-11

Study Completion Date2025-11-01

Terms related to this study

Keywords Provided by Researchers

neck zones.
submental
Facial
Skin laxity

Additional Relevant MeSH Terms

Lax Skin