Energy Devices for Rejuvenation
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|ClinicalTrials.gov Identifier: NCT03767972|
Recruitment Status : Enrolling by invitation
First Posted : December 7, 2018
Last Update Posted : April 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|Rejuvenation||Device: Energy-based device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||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.|
|Masking:||None (Open Label)|
|Official Title:||Energy Devices for Rejuvenation|
|Actual Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2021|
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
Patients will receive one treatment for rejuvenation using one or multiple energy-based devices based on investigator discretion.
Other Name: Fraxel Restore, Helios III, PicoWay, Halo, ThermiVa, DiVa
- Global Aesthetic Improvement Scale [ Time Frame: 3 months ]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".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03767972
|United States, California|
|University of California, Irvine, Dermatology Clinical Research Center|
|Irvine, California, United States, 92697|