An interventional study of Focal Contouring System in Skin Laxity, sponsored by Recros Medica, Inc.. Status unknown at 14 sites in United States. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-06.
Sponsored by Recros Medica, Inc. · Not applicable, Interventional, and Treatment
Efficacy and safety of Rotational Fractional Resection (skin resection) in patients with moderate to severe submental skin laxity.
This is a prospective, multi-center, single-arm (non-randomized), interventional cohort, non-significant risk (NSR) study designed to investigate the efficacy and safety of Rotational Fractional Resection (skin resection) in patients with moderate to severe submental skin laxity. The total duration of study participation for each subject is approximately up to 4 months for each subject from the screening visit to the exit visit. The follow-up period will be approximately 3 months after the procedure. Eligible subjects will complete a total of 11 study visits: screening, procedure, and follow-up visits at 1, 2-4, 7, 14, 21, 30, 45, 60, and 90 days post-procedure.
Exclusion Criteria:
Single treatment of skin resection (removal of loose skin)
Device: Focal Contouring System
Single treatment of skin resection (removal of loose skin)
Improved Skin Laxity
Comparison of the submentum before and after procedure using the Submental Skin Laxity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe)
Time frame: Pre-treatment and 90 days after treatment
Subject Satisfaction: Subject Satisfaction Questionnaire
Comparison of Subject satisfaction of the procedure as assessed using the Subject Satisfaction Questionnaire
Time frame: Pre-treatment and 90 days after treatment
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.