A newly listed clinical trial details how the Ulthera System will be trialled as a treatment for the redness of rosacea.
Trialists will receive `dual depth’ treatments (called Ultherapy) to their cheeks and subsequently assessed on how well it improves the redness associated with their rosacea.
Ultherapy is an ultra sonic treatment that is said to use “the body’s own natural healing process to lift, tone, and tighten loose skin on the brow, neck, and under the chin.”
Ultherapy is FDA approved as a “energy-based device” as a “non-invasive aesthetic lift indication.”
Other Ultherapy publicity describes the technology as being superior to lasers and radio frequency as it “delivers energy with the optimal Depth, Temperature and Precision necessary to lift skin.” The accompanying graphic suggests that the treatments is able to deliver energy as deep as 4.5 mm below the surface of the skin.
It will be interesting to see if such a deep treatment can result in for example collagen changes that might support improvements in vascular level indications like Erythematotelangiectatic Rosacea.
NCT01756027 Ulthera System for the Treatment of Rosacea
Evaluation of the Effectiveness and Safety of the Ulthera System for Treatment of Erythematotelangiectatic Rosacea.
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.
Primary Outcome Measures:
Improvement in Erythematotelangiectatic Rosacea of treatment area versus control. As determined by Primary Investigator assessment.
This study is a prospective, randomized, single-center clinical trial.
The study will be conducted in two Phases. In Phase I, subjects will be assigned to one of two treatment groups. One study group will receive one dual depth Ultherapy treatment to a region on the cheeks, and one study group will receive two dual depth Ultherapy treatments to a region on the cheeks 14 days apart. Average pain scores will be obtained using a Numeric Rating Scale following each region of treatment and for each depth of treatment.
In Phase II, based on observations of last follow-up visit in Phase I (at 90 days after treatment), subjects will be given the option to receive treatment of the affected area(s) for the protocol specified region, treated at the treatment depth showing the most efficacy in Phase I. Efficacy will be determined by improvement in Erythematotelangiectatic Rosacea in the treatment area versus control (an untreated area) as determined by primary investigator assessment at the last follow-up visit in Phase I.
