Feasibility Study: Evaluation of the Treatment of Striae Using Ultherapy® in Combination With Laser Treatment

Completed · Not applicable

Conditions studied: Scars, Striae

In brief

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.

Key facts

Study ID

NCT01810484

Run by

Ulthera, Inc

People needed

14

Starts

2013-01-01

Expected to finish

2015-01-01

Last updated by the study team

2018-01-31

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Art Plastic Surgery — Paramus, New Jersey, United States
• Dermatology, Laser & Vein Specialists of the Carolinas — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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