Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04146584
Other study ID # Sofwave04
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 20, 2019
Est. completion date March 30, 2021

Study information

Verified date July 2021
Source Sofwave Medical LTD
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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. Up to 112 healthy candidates who are seeking treatment from participating investigators will be enrolled at up to 5 participating study sites. Patients will receive 2 treatments (4-6 weeks ± 2 weeks apart) with the SofWave system and will be followed up to 3 months post the last treatment (FU2).


Recruitment information / eligibility

Status Completed
Enrollment 93
Est. completion date March 30, 2021
Est. primary completion date March 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Years to 80 Years
Eligibility 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 Epileptic seizures. 6. History of severe migraine tendency. 7. History of smoking in past 10 years. 8. History of chronic drug or alcohol abuse. 9. Excessive subcutaneous fat on the cheeks. 10. Significant scarring in the area to be treated. 11. Severe or cystic facial acne, acutance uses during past 6 months. 12. Presence of a metal stent or implant in the facial area. 13. Inability to understand the protocol or to give informed consent. 14. On-going use of psychiatric medication. 15. 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. 16. Taking Isotretinoin or other oral retinoid within the past 6 months; taking psychiatric drugs, anti-platelet or anti-coagulant within the past 2 weeks. 17. As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study. -

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Sofwave Treatments
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.

Locations

Country Name City State
United States Dermatology, Laser & Vein Specialists of the Carolinas Charlotte North Carolina
United States Dermatology & Laser Surgery Center Houston Texas
United States Laser & Skin Surgery Center of New York® New York New York
United States New York Laser & Skin Care New York New York
United States Laser & Skin Surgery Center of Northern California Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
Sofwave Medical LTD

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Quantitative Photo Analysis Photo analysis and measurements. Success criterion: point estimate of eyebrow lift > 0.5 mm Objective measurement of submental lift Success criterion: point estimate of submental lift > 20 mm. The primary endpoint would only be achieved along with success in outcome #5. 3 months post last follow up visit
Primary 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
Primary 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 Efficacy Investigator Assessments Evaluate investigator assessment of clinical improvement in the treated zones using the Physician Global Aesthetic Improvement Scale (PGAIS). In this scale the treating physician would have to select the proper answer regarding treatment efficacy out of 5 options ranging from: 1. Very Much Improved to 5. Worse. Each treated zone (Eyebrows, Neck & Submental) would be ranked individually. On the second treatment visit date (pre treatment), 3 months post last treatment follow up visit
Secondary Subject Efficacy Assessments Evaluate patient assessment of clinical improvement in the treated zones and treatment satisfaction using the patient satisfaction questionnaire. The patient would be given a patient satisfaction questionnaire with three questions regarding overall improvement (scale of 5 options ranging from 0. Worse to 4. Very much improved ), overall satisfaction (scale of 5 options ranging from 0. Very Satisfied to 4. Very Unsatisfied) and a question regarding willing to participate in future studies (options of Yes, No, Not sure). Each treated zone (Eyebrows, Neck & Submental) would be ranked individually. On the second treatment visit date (pre treatment), 3 months post last treatment follow up visit
See also
  Status Clinical Trial Phase
Completed NCT05098912 - Comparing Polydioxanone Thread Embedding Acupuncture and Manual Acupuncture for Nasolabial Fold Reduction N/A
Completed NCT05271136 - A Clinical Study to Evaluate the Efficacy of an Anti-Aging Serum N/A
Completed NCT05096247 - Post Market Study To Collect Efficacy Data For The Treatment Of Wrinkles With A Radiofrequency Device N/A
Completed NCT05097157 - Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions N/A
Completed NCT04128046 - The Effect of Platelet-rich Fibrin Matrix on Skin Rejuvenation N/A
Active, not recruiting NCT04727099 - Clinical Evaluation to Demonstrate the Safety and Performance of the Candela PicoWay System™ N/A
Active, not recruiting NCT06140628 - A 28-day Clinical Study on Facial Skin Rejuvenation N/A
Not yet recruiting NCT05524779 - BTL-785F Device for Non-invasive Reduction of Wrinkles and Overall Facial Improvement N/A
Completed NCT05514782 - A Clinical Study to Evaluate the Long-Term Efficacy and Tolerability of a Daily Anti-Aging Daily Serum N/A
Completed NCT06123572 - A Clinical Study to Assess the Safety and Effectiveness of Anti-Ageing and Skin Brightening Gel N/A
Completed NCT04911374 - An Open-Label Clinical Study to Evaluate the Efficacy of a Face Cream and Eye Cream N/A
Recruiting NCT04989361 - Soluble Hyaluronic Acid Microneedle VS. Non-ablative Fractional Laser on Infraorbital Wrinkles. N/A
Recruiting NCT04540900 - A Phase I Study of KB301, a Replication-Incompetent, Non-Integrating Vector Expressing Human Type III Collagen (COL3) for the Treatment of Superficial Skin Depressions Phase 1
Recruiting NCT06074276 - The Effects of Almond on Facial Skin Collagen and Wrinkles N/A
Recruiting NCT06202274 - Clinical Study to Evaluate the Safety and Efficacy of Candela Technology N/A
Completed NCT06366503 - Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With Fractional Ablative CO2 Laser for Facial Rejuvenation N/A
Active, not recruiting NCT06219278 - A Retrospective Review Evaluating the Matrix Pro Applicator for Treatment of Wrinkles N/A
Active, not recruiting NCT06192550 - Functional Usability and Feasibility Testing of the Profound Matrix™ System N/A
Completed NCT04650620 - Study to Evaluate the Performance and Safety of the Medical Device Plenhyage® N/A
Completed NCT03729700 - The Effect of Almonds on Facial Aesthetics and Modulation of the Microbiome and Lipidome N/A