NCT02144181

Ultherapy® for the Treatment of Erythematotelangiectatic Rosacea

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Ulthera, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Erythematotelangiectatic Rosacea
• Rosacea

Interventions

Type	Name	Description
DEVICE	Ulthera System Treatment	Focused ultrasound energy delivered below the surface of the skin

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-12-01
• Completion: 2016-10-01
• First posted: 2014-05-21
• Last updated: 2018-01-31

Locations

5 sites across 2 countries: United States, Canada