Treatment for Lifting Upper Arm Lax Skin

Completed · Not applicable

Conditions studied: Lax Skin

In brief

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

Key facts

Study ID

NCT05358327

Run by

Sofwave Medical LTD

People needed

50

Starts

2022-05-01

Expected to finish

2023-02-01

Last updated by the study team

2023-11-18

Who can join

Age: 35 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female subjects > 35 years of age and < 70 years of age.
• 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.
• Desire to undergo upper arms skin lax lifting treatments.
• Subject has clearly visible lax skin on the upper arm, which in the investigator's opinion, may benefit from the treatment.
• Subject agrees to maintain his/her weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine during the course of the study.
• Able and willing to comply with all visits, treatments and evaluations schedules and requirements.
• Willing to have research photos taken of treatment areas.
• Subject agrees not to undergo any other upper arm skin lax treatments for a period of 3 months following Sofwave treatment.
• Able to understand and provide written Informed Consent.

You may not qualify if…

• Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
• Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area.
• Medical disorder that would hinder the wound healing or immune response (such as blood disorder, inflammatory disease, etc.).
• History of Epileptic seizures.
• Known allergy to lidocaine or epinephrine or antibiotics.
• 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.
• Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen.
• History of significant lymphatic drainage problems.
• Currently heavy smoker or has history of heavy smoking (25 cigarettes per day or more) in past 10 years.
• History of chronic drug or alcohol abuse.
• History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
• Currently taking or has taken diet pills or weight control supplements within the past month.
• BMI>=30kg/m2
• Non-stable weight nominally ±5% for at the past month.
• Active implanted device such as a pacemaker, defibrillator, or drug delivery system.
• History of epidermal or dermal disorders (particularly involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders.
• History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.).
• History of prior surgery in the upper arms.
• Excessive subcutaneous fat on the upper arms.
• Severe solar elastosis on the intended to treat area.
• Significant scarring, atrophic scars in the area to be treated, or has a history of atrophic scars or keloids or prone to bruising.
• Tattoo or former tattoo at or near treatment area.
• Presence of an implant in or adjacent to area of intended treatment (upper arms).

Where it is running

• Laser & Skin Surgery Center of Northern California — Sacramento, California, United States
• Advanced Dermatology — Lincolnshire, Illinois, United States
• Laser & Skin Surgery Center of New York® — New York, New York, United States
• Main Line Center for Laser Surgery — Ardmore, Pennsylvania, United States

Full record on ClinicalTrials.gov

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