Trial Outcomes & Findings for Energy Devices for Rejuvenation (NCT NCT03767972)
NCT ID: NCT03767972
Last Updated: 2026-02-12
Results Overview
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".
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
3 months
Results posted on
2026-02-12
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Energy Devices for Rejuvenation
Baseline characteristics by cohort
| Measure |
Rejuvenation
n=24 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=41 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=41 Participants
|
|
Age, Continuous
|
47.5 years
n=41 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=41 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=41 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 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.
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".
Outcome measures
| Measure |
Rejuvenation
n=4 Participants
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.
|
|---|---|
|
Global Aesthetic Improvement Scale - Physician
|
3 units on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 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.
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".
Outcome measures
| Measure |
Rejuvenation
n=4 Participants
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.
|
|---|---|
|
Global Aesthetic Improvement Scale - Patient
|
3.5 units on a scale
Standard Deviation 0.58
|
Adverse Events
Rejuvenation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Natasha Mesinkovska, MD, PhD, Associate Professor, Dermatology
University of California, Irvine
Phone: 949-824-5515
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place