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Feasibility Study: Ulthera System for the Treatment of Rosacea

NCT01756027 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-11-24

No results posted yet for this study

Summary

Up to 12 subjects will be enrolled. Enrolled subjects will receive one or two Ultherapy treatments on the cheeks, depending on their assigned study group. Follow-up visits will occur 14, 30 and 90 days post-treatment. Study images will be obtained pre-treatment, 30-60 min post-treatment, and at each follow-up visit.

Conditions

  • Erythematotelangiectatic Rosacea

Interventions

DEVICE

Ulthera System providing one treatment per cheek

Focused ultrasound energy delivered below the surface of the skin per cheek.

DEVICE

Ulthera System providing two treatments per cheek

Focused ultrasound energy delivered below the surface of the skin

Sponsors & Collaborators

  • Ulthera, Inc

    lead INDUSTRY

Principal Investigators

  • Mark Lupin, M.D. · Cosmedica

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-05-31
Completion
2013-10-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01756027 on ClinicalTrials.gov