The INFORM Study: Rotational Fractional Resection for Submental Contouring

Status Active, not recruiting

Clinical Trial Summary

Efficacy and safety of Rotational Fractional Resection (skin resection) in patients with moderate to severe submental skin laxity.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03853980
Study type	Interventional
Source	Recros Medica, Inc.
Contact
Status	Active, not recruiting
Phase	N/A
Start date	March 18, 2019
Completion date	October 31, 2020

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