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Safety and Efficacy of Sofwave Treatment for Acne Scars Appearance Improvement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05358860
Recruitment Status : Recruiting
First Posted : May 3, 2022
Last Update Posted : April 11, 2023
Sponsor:
Information provided by (Responsible Party):
Sofwave Medical LTD

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 1, 2022
Estimated Primary Completion Date : September 10, 2023
Estimated Study Completion Date : September 10, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

Arms and Interventions
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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 Name: SUPERB


Outcome Measures
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Primary Outcome Measures :
  1. Rate of change of acne scars appearance, as assessed by independent masked evaluators at 3 months post last treatment session. [ Time Frame: 1 year ]
    following Sofwave treatments based on 6 points simplified Acne Severity Scale (ASS), as evaluated by independent masked reviewers.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05358860


Contacts
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Contact: Shlomit Mann, MSc +97247800268 Shlomit@sofwave.com
Contact: Ruthie Amir, MD +97243003164 Ruthie@sofwave.com

Locations
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United States, New Jersey
SLSS, a Division of Schweiger Dermatology Group Research Office Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Diana Aranzazu    201-951-0701    dianaa@skinandlasers.com   
Principal Investigator: David Goldberg, MD         
Sub-Investigator: Amy Tank, PA         
United States, New York
UnionDerm Recruiting
New York, New York, United States, 10003
Contact: Danielle Robinson    212-366-5400    research@unionderm.com   
Principal Investigator: Anne M. Chapas, MD         
Laser & Skin Surgery Center of New York® Recruiting
New York, New York, United States, 10016
Contact: Jennifer Moreno    212-686-7306    mail@laserskinsurgery.com   
Principal Investigator: Roy Geronemus, MD         
New York Laser & Skin Care Enrolling by invitation
New York, New York, United States, 10028
Sponsors and Collaborators
Sofwave Medical LTD
More Information
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Responsible Party: Sofwave Medical LTD
ClinicalTrials.gov Identifier: NCT05358860    
Other Study ID Numbers: Sofwave09
First Posted: May 3, 2022    Key Record Dates
Last Update Posted: April 11, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Acne Vulgaris
Hypertrophy
Acneiform Eruptions
 Skin Diseases
Sebaceous Gland Diseases
Pathological Conditions, Anatomical