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

NCT01618864 | Completed Results

• 1 other identifier: Luxe01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief 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. Evaluations of improvement will be conducted at the clinic after enrollment and during the treatment at 1, 2, 4, and 8 weeks after initiation.

Conditions

Rosacea; Wrinkles

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Subject Improvement Using the Global Aesthetic Improvement (GAI) Scale

  4, 8 weeks

• Reduction in Rosacea by the Study Investigator Using a Validated Scale

  4, 8 weeks

Study Arms (1)

Luxe

OTHER

Device: Luxe

Interventions

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.

Luxe

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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:

• 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.

Sponsors & Collaborators

• Syneron Medical: lead

Study Sites (2)

New York Laser & Skin Care

New York, New York, 10028, United States

Location

Sadick Dermatology

New York, New York, 10075, United States

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Small number of subjects analyzed for post-marketing study.

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: Iluminage

doranr@iluminagebeauty.com

+972 547 800 260

Study Officials

• Neil Sadick, MD

  Sadick Dermatology

  PRINCIPAL INVESTIGATOR

• Arielle NB Kauvar, MD

  New York Laser & Skin Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: June 13, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 11, 2014
• Results First Posted: August 11, 2014

Record last verified: 2014-07

Locations

US (2)