RosaceaNCT01618864
Safety and Efficacy of the Luxe Device to Treat Facial Wrinkles and Rosacea
A study testing Luxe in people with Rosacea and Wrinkles, run by Syneron Medical at 2 sites in United States.
Trial summary
This study is designed to evaluate the efficacy and safety of the Luxe™ device for use in wrinkle and rosacea treatment. Up to 60 subjects will treat their periorbital and cheek areas daily for 4 weeks and then twice a week for an additional 4 weeks. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- What is being tested?
- Luxe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female between the ages of 21 and 60.
- Non-smoker.
- Have no prior experience with the Luxe™ device.
- Having wrinkles, rhytides and fine lines in periorbital regions that are classified as wrinkle type 1-3 on the Crow's Feet Grading Scale and/or having rosacea cheeks regions.
- Able and willing to comply with all visit, treatment and evaluation schedules and requirements.
- Agree to make no changes in their existing skin-care regime, other than use of the study products, during the study period.
- Able to understand and provide written Informed Consent.
- Women of child-bearing age should pass a negative pregnancy test, and required to be using a reliable method of birth control at least 3 months prior to and throughout study enrollment.
Who cannot join
- Fail to meet any of the inclusion criteria above.
- Subject unable or unwilling to provide proper informed consent for participation.
- Subject not able to understand the requirements of the study.
- Pregnant or nursing women or intending to become pregnant during the course of study.
- Reported having one of the following medical conditions that could result in potential harm to themselves or other:
- Obvious cognitive deficit.
Show all 39Show fewer
- Neuromotor control difficulty with either hand.
- Sensitivity to light.
- History of light activated medical problems such as light triggered seizure disorders or migraine headaches.
- Taking drugs which may cause light sensitivity.
- Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
- Having a permanent implant in the treated area, such as metal plates and screws
- Unable or unlikely to refrain from tanning, including the use of tanning booths, during the course of the study.
- Prior or current skin therapy that may interfere with the evaluation of the study device: Renova, AHAs, Vitamin C, Kinerase, Tretinoin, Topical Retinoids, Topical Steroids, Antibiotics (topical or oral) within 14 days of baseline visit.
- Oral Retinoids within 6 month of baseline visit.
- Use of oral Isotretinoin (Accutane®) within 6 months of initial treatment or during the course of the study.
- Subject currently being treated for a dermatologic condition which may interfere with the safe evaluation of the study device (Eczema, Psoriasis, Severe sun damage, Dermatitis).
- Patient on systemic corticosteroid therapy 6 months prior to and throughout the course of the study.
- Subject with a history of hypersensitivity or allergy to (LED) light.
- Subject with a history of hypersensitivity or allergy to any formulation or device component.
- Having received a facial dermabrasion or chemical peel treatment within 3 months of treatment or during the study.
- Prior skin treatment with laser in treated area within 3 months of initial treatment or during the course of the study.
- Prior use of Botox, collagen, fat injections and /or other methods of skin augmentation (enhancement with injected or implanted material) in treated area within 2 month of initial treatment or during the course of the study. Treatment may not be performed, at all, over permanent dermal implants.
- Prior ablative resurfacing procedure, brow lift, blepharoplasty or face lift in treated area with laser or other devices within 12 months of initial treatment or during the course of the study.
- Any other surgery in treated area within 12 months of initial treatment or during the course of the study.
- History of keloid formation or poor wound healing in a previously injured skin area.
- History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).
- Open laceration or abrasion of any sort on the area to be treated.
- Active Herpes Simplex I at the time of treatment.
- Multiple dysplastic nevi in the area to be treated.
- Having a bleeding disorder or taking anticoagulation medications, including heavy use of aspirin, in a manner which does not allow for a minimum 10 day washout period prior to the treatment (as per the subject's physician discretion).
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
- Having any form of active cancer (especially skin cancer: BCC, SCC, and Melanoma) at the time of enrollment and during the course of the study.
- Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the investigator would interfere with the treatment, or healing process.
- Subjects who have initiated treatment with hormones including estrogen, progesterone, or oral contraceptives for 12 weeks or less, immediately preceding study entry, who intend to discontinue hormonal therapy during the study.
- Participation in a study of another device or drug within 1 month prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria.
- Subjects with history of past or present drug/ alcohol abuse.
- Mentally incompetent, prisoner or evidence of active substance.
- Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New York Laser & Skin Care
New York, New York, 10028
Sadick Dermatology
New York, New York, 10075
About this study
Official title: Safety and Efficacy Evaluation of the Luxe™ Device for the Treatment of Facial Wrinkles and Rosacea
This study is designed to evaluate the efficacy and safety of the Luxe™ device for use in wrinkle and rosacea treatment.
Up to 60 subjects will treat their periorbital and cheek areas daily for 4 weeks and then twice a week for an additional 4 weeks. Evaluations of improvement will be conducted at the clinic after enrollment and during the treatment at 1, 2, 4, and 8 weeks after initiation.
- Being tested
- Luxe
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LuxeDevice
Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Luxe | Other | Not described Receives: Device: Luxe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Investigator Assessment of Overall Global Aesthetic Improvement Scale (GAI)
Data reported as percentage of participants showing improvement in overall score as assessed by investigator. 5 point scale of 0 (no difference) to 4 (Significantly marked improvement)provided for overall improvement in skin texture, roughness, skin color (even/blotchy), erythema and photo-damage.
Measured: 4, 8 weeks
Secondary outcomes (2)
Subject Improvement Using the Global Aesthetic Improvement (GAI) Scale
Data reported as percentage of participants showing improvement in overall score as assessed by subject. 5 point scale of 0 (no difference) to 4 (Significantly marked improvement) provided for overall improvement in skin texture, roughness, skin color (even/blotchy), erythema and photo-damage. Analogous to Outcome Measure 1.
Measured: 4, 8 weeks
Reduction in Rosacea by the Study Investigator Using a Validated Scale
Data reported as percentage of participants showing improvement in rosacea scale: 4 point scale for presence of rosacea features from 0 (absent) to 3 (severe) for: flushing, nontransient erythema, papules and pustules and telangiectasia.
Measured: 4, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for RosaceaStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neil Sadick, MD, Principal investigator, Sadick DermatologyArielle NB Kauvar, MD, Principal investigator, New York Laser & Skin Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618864
- Sponsor's protocol ID
- Luxe01
- Status last verified
- Jul 2014
- First submitted
- 11 Jun 2012
- Last updated
- 11 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Evaluation of the Luxe™ Device for the Treatment of Facial Wrinkles and Rosacea
- ClinicalTrials.gov ID
- NCT01618864
- Acronym / sponsor ID
- Luxe01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Jun 2012 (estimated)
- Results
- Posted 11 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the efficacy and safety of the Luxe™ device for use in wrinkle and rosacea treatment.
Up to 60 subjects will treat their periorbital and cheek areas daily for 4 weeks and then twice a week for an additional 4 weeks. Evaluations of improvement will be conducted at the clinic after enrollment and during the treatment at 1, 2, 4, and 8 weeks after initiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Luxe | Other | Device: Luxe |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy male or female between the ages of 21 and 60.
- Non-smoker.
- Have no prior experience with the Luxe™ device.
- Having wrinkles, rhytides and fine lines in periorbital regions that are classified as wrinkle type 1-3 on the Crow's Feet Grading Scale and/or having rosacea cheeks regions.
- Able and willing to comply with all visit, treatment and evaluation schedules and requirements.
Key exclusion criteria (39 listed)
- Fail to meet any of the inclusion criteria above.
- Subject unable or unwilling to provide proper informed consent for participation.
- Subject not able to understand the requirements of the study.
- Pregnant or nursing women or intending to become pregnant during the course of study.
- Reported having one of the following medical conditions that could result in potential harm to themselves or other:
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 |
|---|---|---|
| LuxeSelf treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks. | Device | Luxe |
Primary outcome
Improvement in Investigator Assessment of Overall Global Aesthetic Improvement Scale (GAI)
Time frame: 4, 8 weeks
Data reported as percentage of participants showing improvement in overall score as assessed by investigator. 5 point scale of 0 (no difference) to 4 (Significantly marked improvement)provided for overall improvement in skin texture, roughness, skin color (even/blotchy), erythema and photo-damage.
2 secondary outcomes
Subject Improvement Using the Global Aesthetic Improvement (GAI) Scale
Time frame: 4, 8 weeks
Reduction in Rosacea by the Study Investigator Using a Validated Scale
Time frame: 4, 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Neil Sadick, MD principal investigator
Sadick Dermatology
Arielle NB Kauvar, MD principal investigator
New York Laser & Skin Care
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Luxe in people with Rosacea and Wrinkles, run by Syneron Medical at 2 sites 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 8 inclusion and 39 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: finished, as of the sponsor's last update on 11 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 11 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Investigator Assessment of Overall Global Aesthetic Improvement Scale (GAI) (time frame: 4, 8 weeks). 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 11 Aug 2014.