Lutronic Genius System for Neck Treatment

Completed · Not applicable

Conditions studied: Wrinkle, Skin Laxity, Skin Texture Disorder

In brief

The Genius system is substantially equivalent to the Infini device (K121481). The study is a prospective, multi-site, non-randomized study of up to 30 treated subjects presenting for treatment of mild to moderate lines, wrinkles, textural concerns, and/or skin laxity of the neck.

Key facts

Study ID

NCT03534609

Run by

CynosureLutronic

People needed

18

Starts

2018-03-27

Expected to finish

2020-01-10

Last updated by the study team

2020-01-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female, age 18 years and older.
• Subject in good health.
• Fitzpatrick Skin Type I to VI.
• Mild to moderate lines, wrinkles, textural concerns, and/or skin laxity of the neck.
• Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
• Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
• Post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study.
• Absence of physical or psychological conditions unacceptable to the investigator.
• Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
• Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.

You may not qualify if…

• Presence of an active skin condition or infection in the treatment area such as sores, Psoriasis, eczema, rash, severe active inflammatory acne or oral herpes simplex breakout.
• History of skin disorders, keloid scarring, and/or abnormal wound healing.
• Open wounds or lesions in the area(s) to be treated.
• Inability to understand the protocol or to give informed consent.
• History of chronic drug or alcohol abuse.
• History of vascular disease.
• History of bleeding disorders.
• BMI equal to or greater than 30.
• Subjects who are pregnant, nursing, or anticipate a pregnancy during the length of the trial.
• Subjects with current skin cancer or other malignant disease including pre-malignant moles.
• Poorly controlled medical condition that could compromise wound healing or increase risk of infection such as an impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications, radiation therapy, or chemotherapy.
• Subjects with implanted medical devices: pacemaker, cardioverts, superficial metal within the treatment area, and other implantable devices or synthetic fillers.
• Subjects with sensitivity or allergy to gold.
• Subjects with sensitivity or allergy to local anesthetics such as lidocaine or tetracaine.
• Concurrent enrollment in any study involving the use of investigational devices or drugs.
• History of surgical or cosmetic treatments in the area(s) to be treated within the past six months.
• History or current use of the following prescription medications:
• Daily anticoagulants, aspirin, iron supplements, herbal supplements such as ginkgo, ginseng or garlic within the past two weeks;
• Topical retinoid within the past one week; and
• Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.

Where it is running

• Laser and Skin Surgery Center of New York — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.