Histologic Evaluation of Tissue Following Lutronic System Exposure

Status unconfirmed · Not applicable

Conditions studied: Abdominoplasty

In brief

Enrollment of up to 25 subjects; subjects enrolled may be greater than subjects receiving test spot exposure visits. No pre-treatment medication prior to test spot exposure. Up to 6 tattoo points will be applied to each side of the abdomen immediately before or after test spot exposures to map and locate exposed spots on the excised pannis. Tattoos in the area to be resected will be placed to outline the test spot exposure areas. Photographs of exposed sites may be taken at investigator's discretion.

Key facts

Study ID

NCT04207047

Run by

CynosureLutronic

People needed

3

Starts

2018-10-02

Expected to finish

2020-03-31

Last updated by the study team

2019-12-20

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. Protocol Number: L18006 v5.0 11192018 Page 8 of 52
• Abdominoplasty surgery planned and scheduled.
• Understands and accepts the obligation not to undergo any other procedures in the areas to be treated/exposed to Genius test spots until abdominoplasty.
• 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.
• Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening Visit and be willing and able to use an acceptable method of birth control (e.g. barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history:
• Postmenopausal for at least 12 months prior to study;
• Without a uterus and/or both ovaries; or
• Bilateral tubal ligation at least six months prior to study enrollment.
• Absence of physical or psychological conditions unacceptable to the investigator.
• Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.

You may not qualify if…

• 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 sensitivity or allergy to gold.
• 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.
• History of vascular disease.
• History of bleeding disorders.
• History of skin disorders, keloid scarring, and/or abnormal wound healing.
• Presence of an active skin condition or infection in the exposure area such as sores, Psoriasis, eczema, rash, severe active inflammatory acne or oral herpes simplex breakout.
• Open wounds or lesions in the exposure area.
• Subjects with implanted medical devices: pacemaker, cardioverts, superficial metal within the exposure area, and other implantable devices or synthetic fillers within the exposure area.
• History of seizure disorders due to light (Group D).
• History of vitiligo, eczema, or psoriasis (Group D).
• History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation (Group D).
• Excessive or recent significant tan in areas of test spot exposure (Group D).
• Inability to understand the protocol or to give informed consent.
• History of chronic drug or alcohol abuse.
• Concurrent enrollment in any study involving the use of investigational devices or drugs.
• History of surgical or cosmetic treatments in exposure area within the past six months.
• History or current use of the following medications:
• Daily anticoagulants, aspirin, iron supplements, herbal supplements or ointments such as ginkgo, ginseng or garlic;
• Topical retinoid in the exposure area within the past one week; and Protocol Number: L18006 v5.0 11192018 Page 9 of 52
• 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

• William LoVerme, MD — Billerica, Massachusetts, United States

Full record on ClinicalTrials.gov

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