Photoaged Facial SkinNCT03383705
VBeam Prima for Treatment of Photoaged Facial Skin
A study testing VBeam Prima in people with Photoaged Facial Skin, run by Syneron Medical at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Photoaged Facial Skin
- What is being tested?
- VBeam Prima
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2017to 15 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
- 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).
- 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.
- Excessive tan in areas to be treated or unable/unlikely to refrain from tanning during the study.
- Participation in a study of another device or drug within three months prior to enrollment or during the study.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207
Cindy Tucker, RN-C, 704-375-6766
About this study
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
- Being tested
- VBeam Prima
- Keywords
- Photoaged Skin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VBeam PrimaDevice
Up to four treatments will be performed every 4-6 (±1) weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Not described Receives: Device: VBeam Prima |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Improvement Scale
Overall improvement using Global Improvement Scale (0=no response; 4=excellent response).
Measured: 1 or 3 months post last treatment
Secondary outcomes (2)
Wrinkle and Elastosis Score
Improvement using Fitzpatrick Wrinkle Class and Elastosis Score
Measured: 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
Measured: Immediately post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start15 Nov 2017
- Primary completion15 Nov 2018 (estimated)
- Study completion15 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photoaged Facial SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383705
- Sponsor's protocol ID
- DHF24491
- Status last verified
- Dec 2017
- First submitted
- 7 Dec 2017
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VBeam Prima for Treatment of Photoaged Facial Skin
- ClinicalTrials.gov ID
- NCT03383705
- Acronym / sponsor ID
- DHF24491
- Conditions
- Photoaged Facial Skin
- Keywords
- Photoaged Skin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 15 Nov 2018 (estimated)
- Study completion
- 15 Nov 2018 (estimated)
- First posted
- 26 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: VBeam Prima |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VBeam PrimaUp to four treatments will be performed every 4-6 (±1) weeks. | Device | Treatment arm |
Primary outcome
Global Improvement Scale
Time frame: 1 or 3 months post last treatment
Overall improvement using Global Improvement Scale (0=no response; 4=excellent response).
2 secondary outcomes
Wrinkle and Elastosis Score
Time frame: Pre Tx.4, 1 month and 3 months post final treatment
Treatment discomfort based on NRS Scale
Time frame: Immediately post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- Individual participant dataSharing planned: No
Related trials for Photoaged Facial Skin
Recruiting
Study of RRS® HA Long Lasting for Improving Facial Wrinkles and Skin Quality
Photoaged Facial Skin, Photoaging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VBeam Prima in people with Photoaged Facial Skin, run by Syneron Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gilly Munavalli, MD ((704) 375-6766, info@carolinaskin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Improvement Scale (time frame: 1 or 3 months post last treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2017.