Safety and Efficacy of the Luxe Device to Treat Facial Wrinkles and Rosacea
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01618864|
Recruitment Status : Completed
First Posted : June 13, 2012
Results First Posted : August 11, 2014
Last Update Posted : August 11, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Rosacea Wrinkles||Device: Luxe||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy Evaluation of the Luxe™ Device for the Treatment of Facial Wrinkles and Rosacea|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
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.
- 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.
- Subject Improvement Using the Global Aesthetic Improvement (GAI) Scale [ Time Frame: 4, 8 weeks ]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.
- Reduction in Rosacea by the Study Investigator Using a Validated Scale [ Time Frame: 4, 8 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01618864
|United States, New York|
|New York Laser & Skin Care|
|New York, New York, United States, 10028|
|New York, New York, United States, 10075|
|Principal Investigator:||Neil Sadick, MD||Sadick Dermatology|
|Principal Investigator:||Arielle NB Kauvar, MD||New York Laser & Skin Care|