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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 : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Margit Juhasz, MD, University of California, Irvine

Brief 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.

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)
Primary Purpose: Treatment
Official Title: Energy Devices for Rejuvenation
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : December 31, 2019

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.
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




Primary Outcome Measures :
  1. 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".



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
United States, California
University of California, Irvine, Dermatology Clinical Research Center
Irvine, California, United States, 92697
Sponsors and Collaborators
University of California, Irvine

Responsible Party: Margit Juhasz, MD, Clincial Research Fellow, Department of Dermatology, University of California, Irvine
ClinicalTrials.gov Identifier: NCT03767972     History of Changes
Other Study ID Numbers: 2017-4054
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No