Clinical trial NCT01810484: Feasibility Study: Evaluation of the Treatment of Striae Using Ultherapy® in Combination With Laser Treatment
Official title: Feasibility Study: Evaluation of the Ulthera® System in Combination With 70W Alma Pixel CO2 Fractional Ablative Laser for Improvement of Abdominal Striae
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scars
Striae
Keywords: Ulthera® System
Ultherapy® Treatment
Ulthera, Inc.
Ultrasound treatment for skin
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-13
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Male or female, aged 21 to 65 years.
* Subject in good health.
* Fitzpatrick skin classification type 1-5.
* 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.
* 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:

  1. Accutane or other systemic retinoids within the past 12 months;
  2. Antiplatelet agents / Anticoagulants (Coumadin, Heparin, Plavix);
  3. Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing informed consent.

Primary outcomes:
measure: Change from baseline in overall skin texture and appearance of abdominal striae
timeFrame: 90-days post-treatment
Secondary outcomes:
measure: 90 Day Patient Satisfaction
timeFrame: 90 Days post-treatment
measure: 180 Day Patient Satisfaction
timeFrame: 180 Days post-treatment
measure: Change from baseline in overall aesthetic appearance of abdominal striae at 90 days
timeFrame: 90 Days post-treatment
measure: Change from baseline in overall aesthetic appearance of abdominal striae at 180 days
timeFrame: 180 Days post-treatment
measure: Change from baseline in skin striae texture and depth at 90 Days
timeFrame: 90 Days post-treatment
measure: Change from baseline in skin striae texture and depth at 180 Days
timeFrame: 180 Days post-treatment
Other outcomes:
Locations:
city: Paramus
country: United States
facility: Art Plastic Surgery
state: New Jersey
city: Charlotte
country: United States
facility: Dermatology, Laser & Vein Specialists of the Carolinas
state: North Carolina
Study officials:
affiliation: Art Plastic Surgery
name: Luis Zapiach, MD
role: PRINCIPAL_INVESTIGATOR
References: