Lutronic Genius System for Neck Treatment

Last updated: January 10, 2020
Sponsor: LUTRONIC Corporation
Overall Status: Completed

Phase

N/A

Condition

Skin Aging

Treatment

N/A

Clinical Study ID

NCT03534609
L18000
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female, age 18 years and older.

  2. Subject in good health.

  3. Fitzpatrick Skin Type I to VI.

  4. Mild to moderate lines, wrinkles, textural concerns, and/or skin laxity of the neck.

  5. Understands and accepts the obligation not to undergo any other procedures in theareas to be treated through the follow-up period.

  6. Willingness and ability to comply with protocol requirements, including returning forfollow-up visits and abstaining from exclusionary procedures for the duration of thestudy.

  7. Post-menopausal, surgically sterilized, or using a medically acceptable form of birthcontrol at least 3 months prior to enrollment and during the entire course of thestudy.

  8. Absence of physical or psychological conditions unacceptable to the investigator.

  9. Willingness and ability to provide written consent for study-required photography andadherence to photography procedures (i.e., removal of jewelry and makeup).

  10. Willingness and ability to provide written informed consent and HIPAA authorizationprior to performance of any study-related procedure.

Exclusion

Exclusion Criteria:

  1. 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 simplexbreakout.

  2. History of skin disorders, keloid scarring, and/or abnormal wound healing.

  3. Open wounds or lesions in the area(s) to be treated.

  4. Inability to understand the protocol or to give informed consent.

  5. History of chronic drug or alcohol abuse.

  6. History of vascular disease.

  7. History of bleeding disorders.

  8. BMI equal to or greater than 30.

  9. Subjects who are pregnant, nursing, or anticipate a pregnancy during the length of thetrial.

  10. Subjects with current skin cancer or other malignant disease including pre-malignantmoles.

  11. Poorly controlled medical condition that could compromise wound healing or increaserisk of infection such as an impaired immune system due to immunosuppressive diseasessuch as AIDS and HIV, or use of immunosuppressive medications, radiation therapy, orchemotherapy.

  12. Subjects with implanted medical devices: pacemaker, cardioverts, superficial metalwithin the treatment area, and other implantable devices or synthetic fillers.

  13. Subjects with sensitivity or allergy to gold.

  14. Subjects with sensitivity or allergy to local anesthetics such as lidocaine ortetracaine.

  15. Concurrent enrollment in any study involving the use of investigational devices ordrugs.

  16. History of surgical or cosmetic treatments in the area(s) to be treated within thepast six months.

  17. History or current use of the following prescription medications:

  18. Daily anticoagulants, aspirin, iron supplements, herbal supplements such asginkgo, ginseng or garlic within the past two weeks;

  19. Topical retinoid within the past one week; and

  20. Psychiatric drugs that in the investigators opinion would impair the subject fromunderstanding the protocol requirements or understanding and signing the informedconsent.

Study Design

Total Participants: 18
Study Start date:
March 27, 2018
Estimated Completion Date:
January 10, 2020

Study Description

At enrollment, standardized baseline/pretreatment 2D and 3D images will be obtained from each subject. Study subjects will receive three neck treatments completed 30 days apart. Subjects will be contacted via a phone call 3 days following each treatment to assess for adverse events and expected treatment effects. Effectiveness assessments will occur prior to Treatments #2 and #3, and a follow-up visit will be completed at 90 days following Treatment #3. Each assessment visit will include efficacy, adverse events, and expected treatment effects assessments, and post-treatment 2D and 3D digital images will be captured.

Connect with a study center

  • Laser and Skin Surgery Center of New York

    New York, New York 10016
    United States

    Site Not Available

Map preview placeholder

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.