Safety and Efficacy of Sofwave Treatment for Acne Scars Appearance Improvement

NCT05358860 | Completed FDA Device

• 1 other identifier: Sofwave09
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Acne Scars - Mixed Atrophic and Hypertrophic

Keywords

Acne Scars

Outcome Measures

Primary Outcomes (1)

• Rate of change of acne scars appearance, as assessed by independent masked evaluators at 3 months post last treatment session.

  following Sofwave treatments based on 6 points simplified Acne Severity Scale (ASS), as evaluated by independent masked reviewers.

  1 year

Study Arms (1)

Acne Scars

EXPERIMENTAL

Device: Sofwave

Interventions

Sofwave DEVICE

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

Acne Scars

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female subjects \> 22 years of age and \< 80 years of age.
• For female subjects, not pregnant or lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide) or abstinence.
• Seeking treatment for facial acne scars.
• Have visible mild to moderate facial acne scars.
• Agree not to undergo any other facial acne scars treatments for a period of 3 months following Sofwave treatments.
• Willing to have photographs of the treated areas. Agree for de-identified study images to be used in evaluations, publications and presentations.
• Able and willing to comply with all visits, treatments and evaluations schedules and requirements.
• Able to understand and provide written Informed Consent

You may not qualify if:

• Pregnant or planning to become pregnant during the duration of the study, having given birth less than 3 months ago, and/or breast feeding
• Current smoker or has history of heavy smoking (25 cigarettes per day or more) in past 10 years.
• History of severe migraine tendency.
• History of Epileptic seizures.
• History of chronic drug or alcohol abuse.
• Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant within the past 2 weeks.
• Medical disorder that may hinder the wound healing or immune response (such as blood disorder, inflammatory disease, etc.)
• Presence of a metal stent or implant in the facial area.
• Known allergy to tetracaine, Xylocaine or epinephrine.
• Active malignancy or history of malignancy in the past 5 years.
• Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders (i.e. any disease state that in the opinion of the investigator may interfere with the anesthesia, treatment, or healing process).
• History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
• Presence of any active systemic or local infections.
• Severe or cystic facial acne, acutance uses during past 6 months.
• 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 or blepharoplasty within the past 12 months.

Sponsors & Collaborators

• Sofwave Medical LTD: lead

Study Sites (4)

SLSS, a Division of Schweiger Dermatology Group Research Office

Hackensack, New Jersey, 07601, United States

Location

UnionDerm

New York, New York, 10003, United States

Location

Laser & Skin Surgery Center of New York®

New York, New York, 10016, United States

Location

New York Laser & Skin Care

New York, New York, 10028, United States

Location

MeSH Terms

Conditions

Hypertrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

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: April 27, 2022
• First Posted: May 3, 2022
• Study Start: February 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 18, 2023

Record last verified: 2023-04

Locations

US (4)