Status
Conditions
Treatments
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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.
History of chronic drug or alcohol abuse.
History of autoimmune disease.
Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
Subjects who anticipate the need for surgery or overnight hospitalization during the study.
Subjects who, in the investigator's opinion, have a history of poor cooperation,noncompliance with medical treatment, or unreliability.
Concurrent enrollment in any study involving the use of investigational devices or drugs.
Current smoker or history of smoking in the last five years.
History of prior abdominal Suction Assisted Lipectomy or Abdominoplasty.
History of prior Massive Weight Loss
History of using the following prescription medications:
Primary purpose
Allocation
Interventional model
Masking
14 participants in 3 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal