Feasibility Study: Evaluation of the Ulthera® System in Combination With 70W Alma Pixel CO2 Fractional Ablative Laser for Improvement of Abdominal Striae
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Scars
- Sponsor
- Ulthera, Inc
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- Change from baseline in overall skin texture and appearance of abdominal striae
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female, aged 21 to 65 years.
- •Subject in good health.
- •Fitzpatrick skin classification type 1-
- •Striae rubra and alba on the abdomen.
- •Understands and accepts the obligation not to undergo any other procedures in the area(s) to be treated through the follow-up period.
- •Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
- •Absence of physical or psychological conditions unacceptable to the investigator.
- •Willingness and ability to provide written consent for study-required photography and adherence to photography requirements .
- •Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.
- •Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control during the study
Exclusion Criteria
- •Presence of an active systemic or local skin disease that may affect wound healing.
- •Current bacterial or viral infection in the area to be treated.
- •Severe solar elastosis.
- •Significant scarring or burns in area(s) to be treated.
- •Prior radiation therapy in the area(s) to be treated.
- •Open wounds or lesions in the area(s) to be treated.
- •History of keloid or hypertrophic scarring
- •History of irregular pigmentation of the skin, Lichens Planus, Vitiligo or Psoriasis in the treatment area that in the investigators opinion, would put the subject at unnecessary risk.
- •Inability to understand the protocol or to give informed consent.
- •Microdermabrasion, or prescription level glycolic acid treatments to the intended treatment area(s) within two weeks prior to study participation or during the study.
Outcomes
Primary Outcomes
Change from baseline in overall skin texture and appearance of abdominal striae
Time Frame: 90-days post-treatment
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.
Secondary Outcomes
- 90 Day Patient Satisfaction(90 Days post-treatment)
- 180 Day Patient Satisfaction(180 Days post-treatment)
- Change from baseline in overall aesthetic appearance of abdominal striae at 90 days(90 Days post-treatment)
- Change from baseline in overall aesthetic appearance of abdominal striae at 180 days(180 Days post-treatment)
- Change from baseline in skin striae texture and depth at 90 Days(90 Days post-treatment)
- Change from baseline in skin striae texture and depth at 180 Days(180 Days post-treatment)