Safety and Efficacy of Sofwave Treatment for Acne Scars Appearance Improvement

NCT ID: NCT05358860

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-12-31

Brief Summary

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

Detailed Description

Eligible patients will receive 3 treatments (4-6 weeks apart) on the facial acne scars using Sofwave System.

Treatment may be administered after the enrollment and screening at the first visit, or it may occur later following the enrollment and screening activities based on site scheduling availabilities.

All patients will return to the clinic for one follow up visit at 3 months ± 3 weeks post last treatment (FU1). Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.

Conditions

Acne Scars - Mixed Atrophic and Hypertrophic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acne Scars

Group Type: EXPERIMENTAL

Sofwave

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

SUPERB

Eligibility Criteria

Inclusion Criteria

1. Healthy male or female subjects > 22 years of age and < 80 years of age.

2. 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.

3. Seeking treatment for facial acne scars.

4. Have visible mild to moderate facial acne scars.

5. Agree not to undergo any other facial acne scars treatments for a period of 3 months following Sofwave treatments.

6. Willing to have photographs of the treated areas. Agree for de-identified study images to be used in evaluations, publications and presentations.

7. Able and willing to comply with all visits, treatments and evaluations schedules and requirements.

8. Able to understand and provide written Informed Consent

Exclusion Criteria

1. Pregnant or planning to become pregnant during the duration of the study, having given birth less than 3 months ago, and/or breast feeding

2. Current smoker or has history of heavy smoking (25 cigarettes per day or more) in past 10 years.

3. History of severe migraine tendency.

4. History of Epileptic seizures.

5. History of chronic drug or alcohol abuse.

6. Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant within the past 2 weeks.

7. Medical disorder that may hinder the wound healing or immune response (such as blood disorder, inflammatory disease, etc.)

8. Presence of a metal stent or implant in the facial area.

9. Known allergy to tetracaine, Xylocaine or epinephrine.

10. Active malignancy or history of malignancy in the past 5 years.

11. 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).

12. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.

13. Presence of any active systemic or local infections.

14. Severe or cystic facial acne, acutance uses during past 6 months.

15. 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.

16. Inability to understand the protocol or to give informed consent

17. On-going use of psychiatric medication

18. Unable or unwilling to comply with the study requirements and procedures

19. Currently enrolled in a clinical study of any other unapproved investigational drug or device

20. As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sofwave Medical LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

SLSS, a Division of Schweiger Dermatology Group Research Office

Hackensack, New Jersey, United States

UnionDerm

New York, New York, 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

Countries

United States

Other Identifiers

Sofwave09

Identifier Type: -

Identifier Source: org_study_id