Safety and Efficacy of Sofwave Treatment for Acne Scars Appearance Improvement

• Sponsor: Sofwave Medical LTD (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05358860
• Collaborator: (none)
• Enrollment: 60
• Locations: 4
• Arm: 1
• Anticipated Duration (Months): 16.2
• Patients Per Site: 15
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acne Scars - Mixed Atrophic and Hypertrophic	Device: Sofwave	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Sofwave Treatment for Acne Scars Appearance Improvement
• Actual Study Start Date: Feb 1, 2022
• Anticipated Primary Completion Date: Jun 10, 2023
• Anticipated Study Completion Date: Jun 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acne Scars	Device: 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.; Other Names: SUPERB

Outcome Measures

Primary Outcome Measures

1. Rate of improvement of acne scars appearance, as assessed by independent masked evaluators at 3 months post last treatment session. [1 year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SLSS, a Division of Schweiger Dermatology Group Research Office	Hackensack	New Jersey	United States	07601
2	UnionDerm	New York	New York	United States	10003
3	Laser & Skin Surgery Center of New York®	New York	New York	United States	10016
4	New York Laser & Skin Care	New York	New York	United States	10028

Sponsors and Collaborators

• Sofwave Medical LTD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sofwave Medical LTD
• ClinicalTrials.gov Identifier: NCT05358860
• Other Study ID Numbers: Sofwave09
• First Posted: May 3, 2022
• Last Update Posted: May 3, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Sofwave Medical LTD: Acne Scars
• Additional relevant MeSH terms: Acne Vulgaris; Hypertrophy

Study Results

No Results Posted as of May 3, 2022