VBeam Prima for Treatment of Photoaged Facial Skin

NCT03383705 | Unknown FDA Device

• 1 other identifier: DHF24491
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Photoaged Facial Skin

Keywords

Photoaged Skin

Outcome Measures

Primary Outcomes (1)

• Global Improvement Scale

  Overall improvement using Global Improvement Scale (0=no response; 4=excellent response).

  1 or 3 months post last treatment

Secondary Outcomes (2)

• Wrinkle and Elastosis Score

  Pre Tx.4, 1 month and 3 months post final treatment

• Treatment discomfort based on NRS Scale

  Immediately post treatment

Study Arms (1)

Treatment arm

EXPERIMENTAL

Device: VBeam Prima

Interventions

VBeam Prima DEVICE

Up to four treatments will be performed every 4-6 (±1) weeks.

Treatment arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Male or Female at least 18 years of age
• Photoaged facial skin with clinically visible background erythema, telangiectasia, or pigmented lesions
• Fitzpatrick Elastosis Score 2-9
• Fitzpatrick Skin Type I - VI
• Able to read, understand and sign the Informed Consent Form
• Willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions
• Willing to have limited sun exposure for the duration of the study, including the follow-up period
• 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
• 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.

You may not qualify if:

• Pregnant or planning to become pregnant during the study duration.
• Implant in the treated area (such as metal plates or screws) or an injected chemical substance.
• Known collagen (connective tissue) disorder, vascular disease (i.e. saphenous reflux), scleroderma or other autoimmune disease (i.e. rheumatoid arthritis, lupus).
• 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.
• History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
• 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.
• Significant concurrent illness, such as such as cardiac disorders, diabetes (type I or II), or pertinent neurological disorders.
• 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.
• 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.
• History of keloid scarring or of abnormal wound healing.
• Photosensitivity to the device's laser wavelengths, history of ingesting medications known to induce photosensitivity, or history of seizure disorders due to light.
• Surgical, light-based therapy or RF procedures in the treatment area within 3 months of treatment or during the study.
• Any other surgery in the treated area within 3 months of treatment (or more if skin has not healed completely) or during the study.
• Tattoo or permanent make-up in the treated area.
• 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.

Sponsors & Collaborators

• Syneron Medical: lead

Study Sites (1)

Dermatology, Laser & Vein Specialists of the Carolinas

Charlotte, North Carolina, 28207, United States

RECRUITING

Central Study Contacts

Gilly Munavalli, MD

CONTACT

(704) 375-6766; info@carolinaskin.com

Cindy Tucker, RN-C

CONTACT

(704) 375-6766; info@carolinaskin.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 26, 2017
• Study Start: November 15, 2017
• Primary Completion: November 15, 2018
• Study Completion: November 15, 2018
• Last Updated: December 26, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)