VBeam Prima for Treatment of Photoaged Facial Skin

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.

Study Overview

• Status: Unknown
• Conditions: Photoaged Facial Skin
• Intervention / Treatment: Device: VBeam Prima

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gilly Munavalli, MD; Phone Number: (704) 375-6766; Email: info@carolinaskin.com
• Study Contact Backup: Name: Cindy Tucker, RN-C; Phone Number: (704) 375-6766; Email: info@carolinaskin.com

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Recruiting
      • Dermatology, Laser & Vein Specialists of the Carolinas
      • Contact: Cindy Tucker, RN-C; Phone Number: 704-375-6766

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Improvement Scale	Overall improvement using Global Improvement Scale (0=no response; 4=excellent response).	1 or 3 months post last treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wrinkle and Elastosis Score	Improvement using Fitzpatrick Wrinkle Class and Elastosis Score	Pre Tx.4, 1 month and 3 months post final treatment
Treatment discomfort based on NRS Scale	Evaluate treatment discomfort based on NRS Scale as reported by study subjects	Immediately post treatment

Collaborators and Investigators

• Sponsor: Syneron Medical

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2017
• Primary Completion (Anticipated): November 15, 2018
• Study Completion (Anticipated): November 15, 2018

Study Registration Dates

• First Submitted: December 7, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 26, 2017

Study Record Updates

• Last Update Posted (Actual): December 26, 2017
• Last Update Submitted That Met QC Criteria: December 19, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Photoaged Skin
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Facies
• Other Study ID Numbers: DHF24491

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