Energy Devices for Rejuvenation
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 12/9/2018 |
| Start Date: | February 1, 2018 |
| End Date: | December 31, 2019 |
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 Restore, the Halo, the Helios III, the Pico, the ThermiVa and the DiVa which
have all been shown to have efficacy for the rejuvenation of the face, décolletage, hands and
vagina. In this study we propose to compare the efficacy and side effect profile of these
devices for skin rejuvenation of various areas of the body including the face, décolletage,
hands, trunk, upper and lower extremities, and vagina.
for skin rejuvenation. Current devices on the market for rejuvenation include the lasers such
as the Fraxel Restore, the Halo, the Helios III, the Pico, the ThermiVa and the DiVa which
have all been shown to have efficacy for the rejuvenation of the face, décolletage, hands and
vagina. In this study we propose to compare the efficacy and side effect profile of these
devices for skin rejuvenation of various areas of the body including the face, décolletage,
hands, trunk, upper and lower extremities, and vagina.
Inclusion Criteria:
1. 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.
2. Subjects between the ages of 18-85 years old, at the time of consent.
3. Subjects may be male or female.
4. Subjects with Fitzpatrick Skin type I-III (Fraxel Restore, Helios III, Pico) or I-VI
(Halo, ThermiVa, DiVa).
5. 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 Criteria:
1. Children and adolescents (less than 18 years old).
2. Subjects who are not willing or able to provide written consent.
3. Individuals with any significant medical history including skin disorders and eating
disorders as determined by the investigator/physician.
4. 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).
5. Subjects with known blood coagulopathies.
6. 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).
7. 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).
8. Subjects who meet any of the contraindication criteria listed in the product
information for the device the subject will be treated with.
9. Subjects who are self-reported to be currently pregnant or lactating at the time of
treatment.
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