Energy Devices for Rejuvenation

NCT03767972 | Terminated Results DMC FDA Device

• 1 other identifier: 20174054
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Global Aesthetic Improvement Scale - Physician

  Patients will be followed for post-treatment using a physician-reported 5-point likert scale (Global Aesthetic Improvement Scale) from 0="worse" to 4="very much improved".

  3 months

• Global Aesthetic Improvement Scale - Patient

  Patients will be followed for post-treatment using a patient-reported 5-point likert scale (Global Aesthetic Improvement Scale) from 0="worse" to 4="very much improved".

  3 months

Study Arms (1)

Rejuvenation

EXPERIMENTAL

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.

Device: Energy-based device

Interventions

Energy-based device DEVICE

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

Also known as: Fraxel Restore, Helios III, PicoWay, Halo, ThermiVa, DiVa

Rejuvenation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine, Dermatology Clinical Research Center

Irvine, California, 92697, United States

Location

Results Point of Contact

• Title: Natasha Mesinkovska, MD, PhD, Associate Professor, Dermatology
• Organization: University of California, Irvine

nmesinko@uci.edu

949-824-5515

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a prospective clinical trial to compare various energy-based devices for the rejuvenation of the face, neck/décolletage, hands, upper and lower extremities and vagina. Adults seeking rejuvenation of either the face, neck/décolletage, hands, upper and lower extremities, trunk and/or vagina will be treated with appropriate energy-based device(s) based on investigators' discretion. If patients' require rejuvenation of multiple areas, per investigator assessment, they will be allowed to get treatment in multiple areas. Patients will be followed for 3 months post-treatment to determine if the procedure was efficacious for rejuvenation of the area(s) treated.

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 7, 2018
• Study Start: February 1, 2018
• Primary Completion: September 17, 2021
• Study Completion: September 17, 2021
• Last Updated: February 12, 2026
• Results First Posted: February 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)