Not provided
Not provided
Not provided
Not provided
Not provided
The study procedures and enrollment were stopped due to COVID-19 restrictions on non-essential research. The study was not able to continue due to change in research personnel after research was able to resume.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Energy-based device | Device | Patients will receive one treatment for rejuvenation using one or multiple energy-based devices based on investigator discretion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine, Dermatology Clinical Research Center | Irvine | California | 92697 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. Energy-based device: Patients will receive one treatment for rejuvenation using one or multiple energy-based devices based on investigator discretion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. Energy-based device: Patients will receive one treatment for rejuvenation using one or multiple energy-based devices based on investigator discretion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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". | Enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
This study includes 5 to 6 visits and takes about seven hours over a period of 6 months for all laser treatments except for PALLAS treatment. Subjects who receive treatment with the PALLAS laser will receive biweekly treatments for a total of 25 visits (including one month follow-up) and takes about 13 hours over 6 months.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Energy-based device: Patients will receive one treatment for rejuvenation using one or multiple energy-based devices based on investigator discretion. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Natasha Mesinkovska, MD, PhD, Associate Professor, Dermatology | University of California, Irvine | 949-824-5515 | nmesinko@uci.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 27, 2021 | Dec 4, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 4, 2021 | Dec 4, 2025 | ICF_001.pdf |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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". | Enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
Not provided
Not provided
Not provided