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This study is designed to evaluate the efficacy and safety of the Luxeâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Luxe | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luxe | Device | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4, 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Neil Sadick, MD | Sadick Dermatology | Principal Investigator |
| Arielle NB Kauvar, MD | New York Laser & Skin Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Laser & Skin Care | New York | New York | 10028 | United States | ||
| Sadick Dermatology |
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| ID | Title | Description |
|---|---|---|
| FG000 | Luxe Treatment Group | Luxe: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Luxe Treatment Group | Luxe: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | percentage of participants | 4, 8 weeks |
|
Adverse event data collected during 8 weeks of treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | All treated subjects were evaluated for adverse events during the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment | Mild irritation with bumps or pimples on the cheeks |
Small number of subjects analyzed for post-marketing study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | Iluminage | +972 547 800 260 | doranr@iluminagebeauty.com |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| 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. | 4, 8 weeks |
| New York |
| New York |
| 10075 |
| United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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GAI assessment by investigator at 8 weeks.
|
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| Secondary | 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. | Posted | Number | percentage of participants | 4, 8 weeks |
|
|
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| Secondary | 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. | Not all subjects had rosacea. 11 subjects evaluated at baseline and 4 weeks; 9 subjects evaluated at 8 weeks, since 2 subjects lost to follow-up. | Posted | Number | percentage of participants | 4, 8 weeks |
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