An interventional study of Ultherapy® treatment only and Ultherapy® treatment and CO2 laser treatment in Scars and Striae, sponsored by Ulthera, Inc. Completed at 2 sites in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-31.
Sponsored by Ulthera, Inc · Not applicable, Interventional, and Treatment
Up to 20 subjects will be enrolled. Enrolled subjects will receive one of three study treatments in the abdominal region: Ultherapy® only, Ultherapy® and CO2 laser treatment, or CO2 laser treatment only. Follow-up visit will occur at 14, 90 and 180 days post-treatment. Study images will be obtained pre-treatment, approximately 30 minutes post-treatment, and at each follow-up visit.
This is a prospective, randomized, single-blinded, pilot clinical trial to evaluate the use of the Ulthera® System in combination with the 70W Alma Pixel CO2 laser for efficacious results in the treatment of abdominal striae rubra and striae alba. Subjects will be randomized to one of three treatment groups. Study personnel conducting efficacy measures will be blinded to the assigned treatment groups.
Changes from baseline in overall skin texture and appearance of abdominal striae will be assessed at study follow-up visits. 2D images, 3D images and patient satisfaction questionnaires will be obtained.
39 studies on the registry are indexed under Striae Distensae; 6 are open to participants now.
This study's enrollment of 14 is below the median of 28 across 38 interventional studies indexed under Striae Distensae.
Browse Striae Distensae studies →Ulthera, Inc is the lead sponsor of 46 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
History of using the following prescription medications:
The abdominal region will be divided into 3 treatment areas: Treatment Area A, B and C. Treatment Area A will be treated with Ultherapy® treatment only; Treatment Area B will be treated with Ultherapy® treatment and CO2 laser treatment; Treatment Area C will be treated with CO2 laser treatment only
Device: Ultherapy® treatment only · Device: Ultherapy® treatment and CO2 laser treatment · Device: CO2 Laser treatment only
The abdominal region will be divided into 3 treatment areas: Treatment Area A, B and C. Treatment Area A will be treated with Ultherapy® treatment and CO2 laser treatment; Treatment Area B will be treated with CO2 laser treatment only; Treatment Area C will be treated with Ultherapy® treatment only
Device: Ultherapy® treatment only · Device: Ultherapy® treatment and CO2 laser treatment · Device: CO2 Laser treatment only
The abdominal region will be divided into 3 treatment areas: Treatment Area A, B and C. Treatment Area A will be treated with CO2 laser treatment only; Treatment Area B will be treated with Ultherapy® treatment only; Treatment Area C will be treated with Ultherapy® treatment and CO2 laser treatment
Device: Ultherapy® treatment only · Device: Ultherapy® treatment and CO2 laser treatment · Device: CO2 Laser treatment only
Focused ultrasound energy delivered below the surface of the skin
Also known as: Ulthera® System treatment
Ultherapy® treatment: Focused ultrasound energy delivered below the surface of the skin; CO2 Laser: Fractionated energy delivered to the surface of the skin for ablative and thermal injury to the skin layers for resurfacing the skin.
Also known as: Ulthera® System treatment, CO2 Fractional Ablative Laser teatment
CO2 Laser: Fractionated energy delivered to the surface of the skin for ablative and thermal injury to the skin layers for resurfacing the skin.
Also known as: CO2 Fractional Ablative Laser teatment
Change from baseline in overall skin texture and appearance of abdominal striae
A masked, qualitative assessment of change from baseline in the areas treated based a review of 2D images obtained at baseline and 90 days post-treatment.
Time frame: 90-days post-treatment
90 Day Patient Satisfaction
Based on completion of Patient Satisfaction Questionnaires
Time frame: 90 Days post-treatment
180 Day Patient Satisfaction
Based on completion of Patient Satisfaction Questionnaires
Time frame: 180 Days post-treatment
Change from baseline in overall aesthetic appearance of abdominal striae at 90 days
Assessment of change in overall aesthetic appearance of abdominal striae from baseline to 90 days post-treatment based on review of pretreatment and 90 day post-treatment 2D images and a live assessment of the treatment area
Time frame: 90 Days post-treatment
Change from baseline in overall aesthetic appearance of abdominal striae at 180 days
Assessment of change in overall aesthetic appearance of abdominal striae from baseline to 180 days post-treatment based on review of pretreatment and 180 day post-treatment 2D images and a live assessment of the treatment area
Time frame: 180 Days post-treatment
Change from baseline in skin striae texture and depth at 90 Days
Quantitative analysis will be completed comparing 3D images obtained at baseline to 3D images obtained at 90 days post-treatment.
Time frame: 90 Days post-treatment
Change from baseline in skin striae texture and depth at 180 Days
Quantitative analysis will be completed comparing 3D images obtained at baseline to 3D images obtained at 180 days post-treatment.
Time frame: 180 Days post-treatment
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Ulthera, Inc