NCT03409965|CompletedFDA Device
Lutronic Infini and LaseMD Systems in Combination Treatment
Evaluation of the Lutronic Infini and Lutronic LaseMD Systems in Combination Treatment
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Evaluation of the Lutronic Infini and Lutronic LaseMD Systems in Combination Treatment
Sponsor study identifier
interventional
21
1 country
2
Study Start
December 8, 2017
Actual (reported)Primary Completion
August 21, 2018
Actual (reported)Study Completion
August 21, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 21, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 8, 2017
Actual (reported)January 17, 2018
Actual (reported)January 24, 2018
Actual (reported)August 21, 2018
Actual (reported)August 21, 2018
Actual (reported)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
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
Combination treatment of the face and/or neck using the Lutronic Infini System and Lutronic LaseMD System.
A microneedle radiofrequency device
A fractional thulium laser device
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Moradi M.D.
Vista, California, 92083, United States
The Aesthetic Clinique
Santa Rosa Beach, Florida, 32459, United States
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.
Kari Larson, MBA
Sponsor GmbH
21 participants (actual enrollment reported by the registry).
First Submitted
January 17, 2018
First Posted
January 24, 2018
Study Start
December 8, 2017
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
August 21, 2018
Actual (reported)Study Completion
August 21, 2018
Actual (reported)Last Updated
August 23, 2018
Record last verified: 2018-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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