Ultherapy® for the Treatment of Erythematotelangiectatic Rosacea

Status Completed

Clinical Trial Summary

This is a prospective, multi-site (up to 5 sites), single-blinded, randomized trial. Up to 88 subjects will be enrolled and randomized to one of four treatment groups (4 Groups of 22 subjects), and will receive study treatments based on their assigned treatment group. Following study treatments, follow-up visits will occur at 90, 180 and 365 days from each subject's last study treatment.

Clinical Trial Description

Clinician Erythema Assessment (CEA) and Patient Self-Assessment (PSA) scores, assessing severity of erythema, will be obtained prior to study treatment to confirm subject eligibility. Enrolled subjects will receive up to three dual-depth treatments to affected areas of the midface (cheeks, chin, forehead, glabella and nose) each treatment provided approximately 2 weeks apart. Groups A and B will receive low-density treatment, and Groups C and D receive high-density treatment. Groups A and C will receive 2 treatments. Groups B and D will receive 3 treatments. Protocol amended Sept 2014: Groups A and C will receive 1 treatment; Groups B and D will receive 2 treatments. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02144181
Study type	Interventional
Source	Merz North America, Inc.
Contact
Status	Completed
Phase	N/A
Start date	May 2014
Completion date	October 2016

View Details

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