Status:
ENROLLING_BY_INVITATION
Energy Devices for Rejuvenation
Lead Sponsor:
University of California, Irvine
Conditions:
Rejuvenation
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Non-ablative and ablative devices are the most commonly used minimally-invasive treatments for skin rejuvenation. Current devices on the market for rejuvenation include the lasers such as the Fraxel R...
Eligibility Criteria
Inclusion
- Exhibit skin aging and will benefit from skin rejuvenation treatment of the face, neck/décolletage, trunk, hands, upper and lower extremities and/or vagina as determined by the investigator/physician.
- Subjects between the ages of 18-85 years old, at the time of consent.
- Subjects may be male or female.
- Subjects with Fitzpatrick Skin type I-III (Fraxel Restore, Helios III, Pico) or I-VI (Halo, ThermiVa, DiVa).
- Subjects must be able and willing to give written informed consent and to comply with the requirements of this protocol. The consent form has been standardized in English. For those patients who do not read and understand English, a consent form will be standardized and provided in a language that they read and understand if possible.
Exclusion
- Children and adolescents (less than 18 years old).
- Subjects who are not willing or able to provide written consent.
- Individuals with any significant medical history including skin disorders and eating disorders as determined by the investigator/physician.
- Subjects on any substances affecting blood coagulation (including but not limited to aspirin and other non-steroid anti-inflammatory drugs, warfarin, vitamin E, fish oil, heparin, low-molecular weight heparin, novel anti-coagulants).
- Subjects with known blood coagulopathies.
- Subjects with a compromise of local blood supply (including but not limited to recent surgery, severe scarring, autoimmune diseases involving the face, neck/décolletage, trunk, hands or lower extremities such as lupus, morphea, sarcoid or mixed connective tissue disease) (dependent on their treatment group).
- Subjects who have received energy-based rejuvenation treatment of the face, neck/décolletage, trunk, hands, upper and lower extremities, and/or vagina within the past 3 months (dependent on the area they are planning to treat).
- Subjects who meet any of the contraindication criteria listed in the product information for the device the subject will be treated with.
- Subjects who are self-reported to be currently pregnant or lactating at the time of treatment.
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03767972
Start Date
February 1 2018
End Date
December 1 2026
Last Update
May 8 2024
Active Locations (1)
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1
University of California, Irvine, Dermatology Clinical Research Center
Irvine, California, United States, 92697