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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 monthsfollowing Sofwave treatments.
- Willing to have photographs of the treated areas. Agree for de-identified study imagesto be used in evaluations, publications and presentations.
- Able and willing to comply with all visits, treatments and evaluations schedules andrequirements.
- Able to understand and provide written Informed Consent
Exclusion
Exclusion Criteria:
- Pregnant or planning to become pregnant during the duration of the study, having givenbirth 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; takinganti-platelet or anti-coagulant within the past 2 weeks.
- Medical disorder that may hinder the wound healing or immune response (such as blooddisorder, 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. anydisease state that in the opinion of the investigator may interfere with theanesthesia, treatment, or healing process).
- History of immunosuppression/immune deficiency disorders (including HIV infection orAIDS) 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 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.
- 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 ordevice
- 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
Connect with a study center
SLSS, a Division of Schweiger Dermatology Group Research Office
Hackensack, New Jersey 07601
United StatesSite Not Available
Laser & Skin Surgery Center of New York®
New York, New York 10016
United StatesSite Not Available
New York Laser & Skin Care
New York, New York 10028
United StatesSite Not Available
UnionDerm
New York, New York 10003
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.