Status:
COMPLETED
Safety and Efficacy of Sofwave Treatment for Acne Scars Appearance Improvement
Lead Sponsor:
Sofwave Medical LTD
Conditions:
Acne Scars - Mixed Atrophic and Hypertrophic
Eligibility:
All Genders
22-80 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- Inability to understand the protocol or to give informed consent
- On-going use of psychiatric medication
- Unable or unwilling to comply with the study requirements and procedures
- Currently enrolled in a clinical study of any other unapproved investigational drug or device
- As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05358860
Start Date
February 1 2022
End Date
December 31 2022
Last Update
November 18 2023
Active Locations (4)
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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