VBeam Prima for Treatment of Photoaged Facial Skin



Status:Recruiting
Conditions:Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 60
Updated:12/27/2017
Start Date:November 15, 2017
End Date:November 15, 2018
Contact:Gilly Munavalli, MD
Email:info@carolinaskin.com
Phone:(704) 375-6766

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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.


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.
We found this trial at
1
site
Charlotte, North Carolina 28207
Phone: 704-375-6766
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mi
from
Charlotte, NC
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