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Ultherapy® for the Treatment of Erythematotelangiectatic Rosacea

Rosacea Clinical Trial

Official title:
Evaluation of the Safety and Efficacy of the Ulthera® System for the Treatment of Signs and Symptoms of Erythematotelangiectatic Rosacea

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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