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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
88
Focused ultrasound energy delivered below the surface of the skin
Skin Specialists, PC
Omaha, Nebraska, United States
Wilmington Dermatology Center
Wilmington, North Carolina, United States
All About Faces
Hummelstown, Pennsylvania, United States
Laser & Cosmetic Center
Virginia Beach, Virginia, United States
Clinician Erythema Assessment at 90 days post-treatment compared to baseline
Erythema will be assessed on a 5-point Clinician Erythema Assessment (CEA) scale (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe) at baseline and at 90 days post-treatment completion. Success is defined as 1-grade improvement on CEA scale.
Time frame: 90 Days post-treatment
CEA scale at 180 days post-treatment compared to baseline.
Erythema will be assessed on a 5-point Clinician Erythema Assessment (CEA) scale (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe) at baseline and at 180 days post-treatment completion.
Time frame: 180 Days post-treatment
CEA scale at 365 days post-treatment compared to baseline.
Erythema will be assessed on a 5-point Clinician Erythema Assessment (CEA) scale (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe) at baseline and at 365 days post-treatment completion.
Time frame: 365 Days post-treatment
Patient Self-Assessment (PSA) of erythema at 90 Days compared to baseline.
Patient Self-Assessment (PSA) of erythema (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe) completed at 90 Days post-treatment.
Time frame: 90 Days post-treatment
Patient Self-Assessment (PSA) of erythema at 180 Days compared to baseline.
Patient Self-Assessment (PSA) of erythema (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe) completed at 180 Days post-treatment.
Time frame: 180 Days post-treatment
Patient Self-Assessment (PSA) of erythema at 365 Days compared to baseline.
Patient Self-Assessment (PSA) of erythema (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe) completed at 365 Days post-treatment.
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Cosmedica Laser Centre
Victoria, British Columbia, Canada
Time frame: 365 Days post-treatment
Dermatology Life Quality Index (DLQI) Assessment at 90 Days post-treatment
Dermatology Life Quality Index (DLQI) Assessment at 90 Days post-treatment compared to baseline, a 10-question validated questionnaire.
Time frame: 90 Days post-treatment
Dermatology Life Quality Index (DLQI) Assessment at 180 Days post-treatment
Dermatology Life Quality Index (DLQI) Assessment at 180 Days post-treatment compared to baseline, a 10-question validated questionnaire.
Time frame: 180 Days post-treatment
Dermatology Life Quality Index (DLQI) Assessment at 365 Days post-treatment
Dermatology Life Quality Index (DLQI) Assessment at 365 Days post-treatment compared to baseline, a 10-question validated questionnaire.
Time frame: 365 Days post-treatment
Colorimeter at 90 Days post-treatment
Colorimeter at 90 Days post-treatment compared to baseline. An objective evaluation of the intensity of erythema as a measure of redness using a colorimeter.
Time frame: 90 Days post-treatment
Colorimeter at 180 Days post-treatment
Colorimeter at 180 Days post-treatment compared to baseline. An objective evaluation of the intensity of erythema as a measure of redness using a colorimeter.
Time frame: 180 Days post-treatment
Colorimeter at 365 Days post-treatment
Colorimeter at 365 Days post-treatment compared to baseline. An objective evaluation of the intensity of erythema as a measure of redness using a colorimeter.
Time frame: 365 Days post-treatment