Lutronic Infini and LaseMD Systems in Combination Treatment

NCT03409965 | Completed FDA Device

• 1 other identifier: L17002
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective, multi-site, non-randomized study evaluating the safety and effectiveness of the Infini and LaseMD Systems for combination treatment in wrinkles, texture, and pigmentation of the face and/or neck.

Conditions

Face and Neck Wrinkles, Texture, Pigmentation

Outcome Measures

Primary Outcomes (1)

• Masked, qualitative assessment of improvement

  An assessment of paired pre- and post-treatment photographs will be conducted by blinded assessors. Each blinded assessor will be given an identical set of baseline (pre-treatment) and Day 90 follow-up photos to be assessed. Each photo's visit interval, i.e., pre-treatment and follow-up, will NOT be marked. Each blinded assessor will conduct their assessment independently, comparing the Left and Right photos for improvement in the face and/or neck using the following definition: * Change: An improvement that is: * Striking, substantial and immediately noticeable, or * Readily apparent but modest in nature * Slight and subtle in nature, may require close examination The assessor chooses the photo they believe to be the post-treatment photo, i.e., Left photo or Right photo.

  90 days following the last study treatment

Secondary Outcomes (4)

• Clinician assessment of overall aesthetic improvement

  90 days following the last treatment.

• Subject assessment of overall aesthetic improvement

  90 days following the last treatment.

• Patient Satisfaction

  90 days following study treatment

• Treatment-related pain

  For the duration of each study treatment

Study Arms (1)

Lutronic Systems Combination Treatment

EXPERIMENTAL

Combination treatment of the face and/or neck using the Lutronic Infini System and Lutronic LaseMD System.

Device: Lutronic Infini System; Device: Lutronic LaseMD System

Interventions

Lutronic Infini System DEVICE

A microneedle radiofrequency device

Lutronic Systems Combination Treatment

Lutronic LaseMD System DEVICE

A fractional thulium laser device

Lutronic Systems Combination Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age 18 years and older.
• Subject in good health.
• Fitzpatrick Skin Type I to VI.
• Solar elastosis on the face and/or neck.
• Mild to moderate wrinkles of the face and/or neck.
• Mild to moderate textural concerns on the face and/or neck.
• Sun and/or age-related pigmentation on the face and/or neck.
• Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
• Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening Visit and be willing and able to use an acceptable method of birth control (e.g. barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history:
• Postmenopausal for at least 12 months prior to study;
• Without a uterus and/or both ovaries; or
• Bilateral tubal ligation at least six months prior to study enrollment.
• Absence of physical or psychological conditions unacceptable to the investigator.
• Willingness to refrain from use of aspirin, Ibuprofen, Naproxen, or any other NSAID prior to each study treatment and chronic use during the entire post-treatment study period. Washout period, if chronic user, for 4 weeks prior to the first treatment. After all study treatments are completed, limited acute NSAID use is allowed, i.e., a maximum of 2-3 doses in any 2-week period, if needed.
• Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup).

You may not qualify if:

• Presence of an active systemic or local skin disease that may affect wound healing.
• History of keloids or poor wound healing.
• Severe solar elastosis.
• Excessive subcutaneous fat in the area(s) to be treated.
• Excessive skin laxity on the area(s) to be treated.
• Significant scarring in the area(s) to be treated that would interfere with assessing results.
• Open wounds or lesions in the area(s) to be treated.
• Inability to understand the protocol or to give informed consent.
• Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within four weeks prior to study participation or during the study.
• Excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
• BMI equal to or greater than 30.
• History of chronic drug or alcohol abuse.
• History of collagen vascular disease.
• History of autoimmune disease.
• Subjects with implanted pacemaker or defibrillator.

Sponsors & Collaborators

• LUTRONIC Corporation: lead

Study Sites (2)

Moradi M.D.

Vista, California, 92083, United States

Location

The Aesthetic Clinique

Santa Rosa Beach, Florida, 32459, United States

Location

Related Publications (1)

• Moradi A, Weiner SF. Effectiveness of Combining High-Intensity Focused Radiofrequency and Non-Ablative Fractional Laser for Improving the Appearance of the Aging Face and Neck. J Drugs Dermatol. 2019 Jan 1;18(1):59-64.

  PMID: 30681798 DERIVED

MeSH Terms

Conditions

Facies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kari Larson, MBA

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

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

Model Details: Prospective, non-randomized study

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: January 24, 2018
• Study Start: December 8, 2017
• Primary Completion: August 21, 2018
• Study Completion: August 21, 2018
• Last Updated: August 23, 2018

Record last verified: 2018-08

Locations

US (2)