- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03767972
Energy Devices for Rejuvenation
May 6, 2024 updated by: Natasha Mesinkovska, University of California, Irvine
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Irvine, California, United States, 92697
- University of California, Irvine, Dermatology Clinical Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Patients will receive one treatment for rejuvenation using one or multiple energy-based devices based on investigator discretion.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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".
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2018
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
December 4, 2018
First Submitted That Met QC Criteria
December 5, 2018
First Posted (Actual)
December 7, 2018
Study Record Updates
Last Update Posted (Estimated)
May 8, 2024
Last Update Submitted That Met QC Criteria
May 6, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 20174054
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rejuvenation
-
DeNova ResearchCompletedLip RejuvenationUnited States
-
COR clinic of Regenerative MedicineCompleted
-
Erevna Innovations Inc.Completed
-
Goldman, Butterwick, Fitzpatrick and GroffAcclaro CorporationNot yet recruitingFace Rejuvenation | Neck Rejuvenation
-
Musculoskeletal Transplant FoundationCompleted
-
Syneron MedicalCompletedEvaluation of Non-ablative and Fractional Combination Treatment for Improvement in Skin's AppearanceLaser Therapy | Rejuvenation
-
Chulalongkorn UniversityVenus ConceptUnknownSkin Tightening and RejuvenationThailand
-
Alexandria UniversityCompletedLipofilling | Skin RejuvenationEgypt
-
St Joseph University, Beirut, LebanonCompleted
Clinical Trials on Energy-based device
-
Ruijin HospitalTerminated
-
Virginia Commonwealth UniversityNational Cancer Institute (NCI)CompletedDepression | Pain | Breast Cancer | Fatigue | Sleep Disorders | Anxiety Disorder
-
Cynosure, Inc.RecruitingDermatologic ConditionsUnited States
-
Baylor Research InstituteTerminatedMenorrhagiaUnited States
-
NMP Medical Research InstituteWarwick Research Services; Hong Kong Academy of Yoga TherapyCompletedMusculoskeletal Pain | Headache | Stress Related DisorderIndia
-
The San Francisco Clinical Research CenterUnknown
-
CAMC Health SystemUnknownCystic FibrosisUnited States
-
University of MichiganCompleted
-
Chang Gung Memorial HospitalUnknown
-
The Hong Kong Polytechnic UniversityRecruitingPsychological Distress | Physiological Stress | COVID-19 Stress SyndromeHong Kong