Wrinkles, Scars, Stretch Marks, Pigmentation, Skin Laxity
Conditions
Brief summary
The primary objective of this pilot study is exploratory investigation evaluating the Potenza microneedle fractional radiofrequency (RF) device and may be used in combination with the Icon intense pulsed light (IPL) device.
Interventions
DEVICEPotenza
Subjects will receive 1-4 treatments at approximately 1 month intervals, but other intervals from 2 to 12 weeks may take place at the PI's discretion. At the discretion of the PI, additional follow-up visits may take place to observe the time course of skin reactions after treatment and/or to assess if the skin condition continues to improve beyond 3 months after treatment.
DEVICEIcon
Subjects will receive 1-4 treatments at approximately 1 month intervals, but other intervals from 2 to 12 weeks may take place at the PI's discretion. At the discretion of the PI, additional follow-up visits may take place to observe the time course of skin reactions after treatment and/or to assess if the skin condition continues to improve beyond 3 months after treatment.
Sponsors
Cynosure, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomization is not requires, as the group to which a subject is assigned to will be at the discretion of the investigator.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Healthy male or female 18 years of age or older. * Presence of unwanted dermatologic condition suitable for treatment such as facial and/or neck wrinkles, skin laxity of face, neck or body, scars, acne scars or striae, or Vascular and/or pigment dyschromia * Ability to read, understand, and sign the Informed Consent Form * Understands and accepts the obligation not to undergo any other procedures in the areas to be treated and/or weight loss through the follow-up period. * Willing and able to comply with all study participation requirements including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study
Exclusion criteria
* Is pregnant or of childbearing potential and not using (or willing to use) medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study. * Presence of an active systemic or local skin disease or condition that may affect wound healing or interfere with participation. * History of keloids or poor wound healing * Taking medication which is known to increase sensitivity to sunlight * Has a seizure disorders triggered by light * Cancer, malignant disease, skin pathology, condition or allergic reactions that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments * History of collagen, vascular or immunosuppressive or deficiency disorders * History of coagulative disorder or use of anticoagulant drugs within 2 weeks of study treatment * Use of steroids within 2 weeks of study treatments * Use of Accutane (isotretinoin) in the past 12 months * Previous surgical or cosmetic procedure to the target area in the last 6 to 12 months that could interfere with the treatment procedure and affect treatment outcome * Has an implanted pacemaker or defibrillator, metal pins or prosthetic joints * Allergic reaction to gold metal * Receiving or have received gold therapy * Photo-sensitive skin * Psycho-neurotic condition including alcohol or drug abuse * Unwilling or unable to adhere to all study requirements for treatment and follow-up * Has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grading of Skin Aging and Photodamage | 90 days post last treatment | At the 90 day follow up, subjects will be graded on a scale of 0-4 (0 being none and 4 being severe) for the presence of skin aging and photodamage. The # of subjects with improvement will be reported. |
Countries
United States
Outcome results
None listed