Safety and Efficacy of the Luxe Device to Treat Facial Wrinkles and Rosacea

Completed · Not applicable

Conditions studied: Rosacea, Wrinkles

In brief

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.

Key facts

Study ID: NCT01618864
Run by: Syneron Medical
People needed: 23
Starts: 2012-03-01
Expected to finish: 2012-12-01
Last updated by the study team: 2014-08-11

Who can join

Age: 21 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.
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.

Where it is running

New York Laser & Skin Care — New York, New York, United States
Sadick Dermatology — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.