Energy Devices for Rejuvenation

Rejuvenation Clinical Trial

Official title:

Energy Devices for Rejuvenation

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03767972
• Other study ID #: 20174054
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rejuvenation

Intervention

Device:
• Energy-based device
Patients will receive one treatment for rejuvenation using one or multiple energy-based devices based on investigator discretion.

Locations

Country	Name	City	State
United States	University of California, Irvine, Dermatology Clinical Research Center	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Aesthetic Improvement Scale	Patients will be followed for post-treatment using a patient and physician-reported 5-point likert scale (Global Aesthetic Improvement Scale) from 0="worse" to 4="very much improved".	3 months