Energy Devices for Rejuvenation

NCT ID: NCT03767972

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2026-12-31

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 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.

Conditions

Rejuvenation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rejuvenation

Adults requiring rejuvenation of either the face, neck/décolletage, hands, upper and lower extremities, trunk and/or vagina will receive energy-based treatment (Fraxel Restore, Helios III, PicoWay, Halo, ThermiVa or DiVa) based on the investigators' assessment and discretion. The treating physician will decide which energy-based device is best-suited to addressing the patients' aging concerns; although patient preference will be taken into account, ultimately the treating physician will be responsible for the correct assessment of patients' rejuvenation needs and use of appropriate energy-based devices for the final treatment.

Group Type: EXPERIMENTAL

Energy-based device

Intervention Type: DEVICE

Patients will receive one treatment for rejuvenation using one or multiple energy-based devices based on investigator discretion.

Interventions

Energy-based device

Patients will receive one treatment for rejuvenation using one or multiple energy-based devices based on investigator discretion.

Intervention Type: DEVICE

Other Intervention Names

Fraxel Restore, Helios III, PicoWay, Halo, ThermiVa, DiVa

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Natasha Mesinkovska

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of California, Irvine, Dermatology Clinical Research Center

Irvine, California, United States

Countries

United States

Other Identifiers

20174054

Identifier Type: -

Identifier Source: org_study_id