Phase
Condition
Skin Aging
Treatment
N/AClinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject is a healthy Male or Female at least 18 years of age
Subject has a vascular (blood vessels) and skin disorders or erythematous scars orerythematous striae or wishes to improve skin laxity or skin firmness. In specialcases non-erythematous scars or non-erythematous striae may be allowed as well.
Fitzpatrick Skin Type I - VI
Subject must be able to read, understand and sign the Informed Consent Form
Subject must be willing and able to adhere to the treatment and follow-up schedule andpost-treatment care instructions
Subject must be willing to have limited sun exposure for the duration of the study,including the follow-up period
Subject is willing to have photographs and/or videos taken of the treated area whichwill be used, de-identified, in evaluations and may be used, de-identified, inpresentations and/or publications
For female candidates - subject must be post-menopausal, or surgically sterilized, orusing a medically acceptable form of birth control during the entire course of thestudy.
Exclusion
Exclusion Criteria:
Subject is pregnant or planning to become pregnant during the study duration.Pregnancy will be assessed by question at screening.
Subject has an active electrical implant anywhere in the body, such as a pacemaker oran internal defibrillator.
Subject has an implant in the treated area (such as metal plates or screws) or aninjected chemical substance, including Botox and collagen injections (if the face areais treated).
Subject has a known collagen (connective tissue) disorder, vascular disease,scleroderma or other autoimmune disease (i.e. rheumatoid arthritis, lupus).
Subject has a history of diseases stimulated by heat or sun exposure, such asrecurrent Herpes Simplex in the treated area, unless treatment is conducted followinga prophylactic regimen.
Subject has a history of immunosuppression/immune deficiency disorders (including HIVinfection or AIDS) or currently using immunosuppressive medications.
Having or undergoing any form of treatment for active cancer, or having a history ofskin cancer or any other cancer in the areas to be treated, including actinickeratosis, presence of malignant or pre-malignant pigmented lesions.
Subject is suffering from significant concurrent illness, such as such as cardiacdisorders, diabetes (type I or II), or pertinent neurological disorders.
Subject has an infection or is suffering from current or has a history of significantskin conditions in the treated area or inflammatory skin conditions, including, butnot limited to: photodermatoses, active acne, excessive skin dryness, psoriasis,eczema, rash, rosacea (particularly severe open wound stage), varicella scars, openlacerations or abrasions and active cold sores or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatmentcourse.
Having a known anticoagulative or thromboembolic condition or taking anticoagulationmedications one week prior to and during the treatment course (to allow inclusion,temporary cessation of use as per the subject's physician discretion).
Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containingagents) one week before and after each treatment session.
Subject has a history of pigmentary disorders, particularly tendency for hyper- orhypo-pigmentation.
Subject has a history of keloid scarring or of abnormal wound healing.
Subject has a known photosensitivity to the study laser wavelength, history ofingesting medications known to induce photosensitivity, or history of seizuredisorders due to light.
Subject has undergone any surgical, light-based therapy or RF procedures in thetreatment area within 3 months of treatment or during the study.
Having undergone any other surgery in the treated area within 3 months of treatment (or more if skin has not healed completely) or during the study.
Subject has undergone a facial dermabrasion or chemical peel treatment within 3 monthsof treatment or during the study (if face is treated).
Having received Botox/collagen/fat injections or other methods of augmentation withinjected or implanted material in the treated area within 9 months of treatment orduring the study (if face is treated).
Subject has undergone a resurfacing procedure, face lift or eyelid surgery within ayear of treatment or during the study (if face is treated).
Subject has a tattoo or permanent make-up in the treated area.
Subject has systemically used retinoids, antioxidants or medical grade of skinnourishing supplements within 2 months of treatment or during the study.
Excessively tanned in areas to be treated or unable/unlikely to refrain from tanningduring the study.
Participation in a study of another device or drug within three months prior toenrollment or during the study.
As per the Investigator's discretion, any physical or mental condition which mightmake it unsafe for the subject to participate in this study
Study Design
Study Description
Connect with a study center
Scripps Clinic - Carmel Valley
San Diego, California 92130
United StatesSite Not Available
Syneron Candela Institute for Education Clinic
Wayland, Massachusetts 01778
United StatesActive - Recruiting
Zel Skin & Laser Specialists
Edina, Minnesota 55424
United StatesCompleted
Laser and Skin Surgery Center of New York
New York, New York 10016
United StatesCompleted
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