Phase
Condition
Skin Aging
Treatment
N/AClinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 theareas to be treated through the follow-up period.
Willingness and ability to comply with protocol requirements, including returning forfollow-up visits and abstaining from exclusionary procedures for the duration of thestudy.
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.
Absence of physical or psychological conditions unacceptable to the investigator.
Willingness and ability to provide written consent for study-required photography andadherence to photography procedures (i.e., removal of jewelry and makeup).
Willingness and ability to provide written informed consent and HIPAA authorizationprior to performance of any study-related procedure.
Exclusion
Exclusion Criteria:
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.
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 thetrial.
Subjects with current skin cancer or other malignant disease including pre-malignantmoles.
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.
Subjects with implanted medical devices: pacemaker, cardioverts, superficial metalwithin 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 ortetracaine.
Concurrent enrollment in any study involving the use of investigational devices ordrugs.
History of surgical or cosmetic treatments in the area(s) to be treated within thepast six months.
History or current use of the following prescription medications:
Daily anticoagulants, aspirin, iron supplements, herbal supplements such asginkgo, 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 fromunderstanding the protocol requirements or understanding and signing the informedconsent.
Study Design
Study Description
Connect with a study center
Laser and Skin Surgery Center of New York
New York, New York 10016
United StatesSite Not Available

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