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VBeam Prima for Treatment of Photoaged Facial Skin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03383705
Recruitment Status : Unknown
Verified December 2017 by Syneron Medical.
Recruitment status was:  Recruiting
First Posted : December 26, 2017
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
Syneron Medical

Brief Summary:
This is an open-label, single-center study. Subjects in this study will receive up to four (4) facial treatments at 4-6 (±1) weeks interval, with the VBeam Prima device according to the study protocol. Subjects will return for follow-up (FU) visits at the clinic at 1 and 3 months following the last treatment.

Condition or disease Intervention/treatment Phase
Photoaged Facial Skin Device: VBeam Prima Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: VBeam Prima for Treatment of Photoaged Facial Skin
Actual Study Start Date : November 15, 2017
Estimated Primary Completion Date : November 15, 2018
Estimated Study Completion Date : November 15, 2018

Arm Intervention/treatment
Experimental: Treatment arm Device: VBeam Prima
Up to four treatments will be performed every 4-6 (±1) weeks.




Primary Outcome Measures :
  1. Global Improvement Scale [ Time Frame: 1 or 3 months post last treatment ]
    Overall improvement using Global Improvement Scale (0=no response; 4=excellent response).


Secondary Outcome Measures :
  1. Wrinkle and Elastosis Score [ Time Frame: Pre Tx.4, 1 month and 3 months post final treatment ]
    Improvement using Fitzpatrick Wrinkle Class and Elastosis Score

  2. Treatment discomfort based on NRS Scale [ Time Frame: Immediately post treatment ]
    Evaluate treatment discomfort based on NRS Scale as reported by study subjects



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy Male or Female at least 18 years of age
  2. Photoaged facial skin with clinically visible background erythema, telangiectasia, or pigmented lesions
  3. Fitzpatrick Elastosis Score 2-9
  4. Fitzpatrick Skin Type I - VI
  5. Able to read, understand and sign the Informed Consent Form
  6. Willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions
  7. Willing to have limited sun exposure for the duration of the study, including the follow-up period
  8. Willing to have photographs taken of the treated area which will be used, de-identified, in evaluations and may be used, de-identified, in presentations and/or publications
  9. For female candidates - subject must be post-menopausal, or surgically sterilized, or using a medically acceptable form of birth control during the entire course of the study.

Exclusion Criteria:

  1. Pregnant or planning to become pregnant during the study duration.
  2. Implant in the treated area (such as metal plates or screws) or an injected chemical substance.
  3. Known collagen (connective tissue) disorder, vascular disease (i.e. saphenous reflux), scleroderma or other autoimmune disease (i.e. rheumatoid arthritis, lupus).
  4. History of diseases stimulated by heat or sun exposure, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
  5. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
  6. Undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including actinic keratosis, presence of malignant or pre-malignant pigmented lesions.
  7. Significant concurrent illness, such as such as cardiac disorders, diabetes (type I or II), or pertinent neurological disorders.
  8. Infection or are suffering from a current or a history of significant skin conditions in the treated area and/or inflammatory skin conditions, including, but not limited to: photodermatoses, psoriasis, eczema, rash, severe open wound stage rosacea, open cuts or scrapes and active cold sores or herpes sores prior to study treatment or during the study treatment course.
  9. Anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use might be requested as per the subject's physician discretion).
  10. Use of aspirin or pain relievers from the ibuprofen family (e.g., Motrin®, Advil®, or Naprosyn®) on a regular basis or would be taking any of these pain relievers one week before and after each study treatment session.
  11. History of keloid scarring or of abnormal wound healing.
  12. Photosensitivity to the device's laser wavelengths, history of ingesting medications known to induce photosensitivity, or history of seizure disorders due to light.
  13. Surgical, light-based therapy or RF procedures in the treatment area within 3 months of treatment or during the study.
  14. Any other surgery in the treated area within 3 months of treatment (or more if skin has not healed completely) or during the study.
  15. Tattoo or permanent make-up in the treated area.
  16. Systemica use of retinoids (i.e. Retin-A®, Accutane®) or antioxidants (i.e. Restylane®, Strivectin®) within 2 months of study treatment or during the study.
  17. Excessive tan in areas to be treated or unable/unlikely to refrain from tanning during the study.
  18. Participation in a study of another device or drug within three months prior to enrollment or during the study.
  19. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

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): NCT03383705


Contacts
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Contact: Gilly Munavalli, MD (704) 375-6766 info@carolinaskin.com
Contact: Cindy Tucker, RN-C (704) 375-6766 info@carolinaskin.com

Locations
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United States, North Carolina
Dermatology, Laser & Vein Specialists of the Carolinas Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Cindy Tucker, RN-C    704-375-6766      
Sponsors and Collaborators
Syneron Medical
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Responsible Party: Syneron Medical
ClinicalTrials.gov Identifier: NCT03383705    
Other Study ID Numbers: DHF24491
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Syneron Medical:
Photoaged Skin
Additional relevant MeSH terms:
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Facies
Disease Attributes
Pathologic Processes