ClinicalTrials.gg
Status unknownNCT03383705Updated Dec 26, 2017

VBeam Prima for Treatment of Photoaged Facial Skin

An interventional study of VBeam Prima in Photoaged Facial Skin, sponsored by Syneron Medical. Status unknown at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-26.

Sponsored by Syneron Medical · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Photoaged Facial Skin

Keywords

  • Photoaged Skin
03

In context

Lead sponsor

Syneron Medical is the lead sponsor of 41 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 , or surgically sterilized, or using a medically acceptable form of during the entire course of the study.

Exclusion criteria

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 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 /immune deficiency disorders (including 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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Treatment arm

    Device: VBeam Prima

Interventions

  • DeviceVBeam Prima

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

06

What researchers measure

Primary outcomes

  1. Global Improvement Scale

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

    Time frame: 1 or 3 months post last treatment

Secondary outcomes

  1. Wrinkle and Elastosis Score

    Improvement using Fitzpatrick Wrinkle Class and Elastosis Score

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

  2. Treatment discomfort based on NRS Scale

    Evaluate treatment discomfort based on NRS Scale as reported by study subjects

    Time frame: Immediately post treatment

07

Study locations

1 of 1 sites recruiting
  • Dermatology, Laser & Vein Specialists of the Carolinas
    Charlotte, North Carolina 28207, United States
    Recruiting
    • Cindy Tucker, RN-C · Contact704-375-6766
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2017 (actual). Primary completion is estimated for Nov 2018, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 7, 2017
First posted
Dec 26, 2017
StartActual
Nov 15, 2017
Primary completionEst.
Nov 15, 2018
CompletionEst.
Nov 15, 2018
Last update
Dec 26, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03383705
Lead sponsor
Syneron Medical
Responsible party
Sponsor
First posted
Dec 26, 2017
Start date
Nov 15, 2017
Primary completion
Nov 15, 2018 (estimated)
Completion
Nov 15, 2018 (estimated)
Last update
Dec 26, 2017

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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