Safety and Efficacy of Sofwave Treatment for Acne Scars Appearance Improvement

Last updated: November 16, 2023
Sponsor: Sofwave Medical LTD
Overall Status: Completed

Phase

N/A

Condition

Acne

Rash

Inflammatory Comedones

Treatment

Sofwave

Clinical Study ID

NCT05358860
Sofwave09
  • Ages 22-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 monthsfollowing Sofwave treatments.
  6. Willing to have photographs of the treated areas. Agree for de-identified study imagesto be used in evaluations, publications and presentations.
  7. Able and willing to comply with all visits, treatments and evaluations schedules andrequirements.
  8. Able to understand and provide written Informed Consent

Exclusion

Exclusion Criteria:

  1. Pregnant or planning to become pregnant during the duration of the study, having givenbirth 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; takinganti-platelet or anti-coagulant within the past 2 weeks.
  7. Medical disorder that may hinder the wound healing or immune response (such as blooddisorder, 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. anydisease state that in the opinion of the investigator may interfere with theanesthesia, treatment, or healing process).
  12. History of immunosuppression/immune deficiency disorders (including HIV infection orAIDS) 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 facialskin-tightening procedure within the 6 months; injectable (Botox or fillers of anytype) within the 6 months; ablative or non-ablative resurfacing/rejuvenation lasertreatment or light treatment within the past 6 months, dermabrasion or deep facialpeels 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 ordevice
  20. As per the investigator's discretion, any physical or mental condition which mightmake it unsafe for the subject to participate in this study.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Sofwave
Phase:
Study Start date:
February 01, 2022
Estimated Completion Date:
December 31, 2022

Study 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.

Connect with a study center

  • SLSS, a Division of Schweiger Dermatology Group Research Office

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Laser & Skin Surgery Center of New York®

    New York, New York 10016
    United States

    Site Not Available

  • New York Laser & Skin Care

    New York, New York 10028
    United States

    Site Not Available

  • UnionDerm

    New York, New York 10003
    United States

    Site Not Available

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