Status:
COMPLETED
Feasibility Study: Evaluation of the Treatment of Striae Using Ultherapy® in Combination With Laser Treatment
Lead Sponsor:
Ulthera, Inc
Conditions:
Scars
Striae
Eligibility:
All Genders
21-65 years
Phase:
NA
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 on...
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 treat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01810484
Start Date
January 1 2013
End Date
January 1 2015
Last Update
January 31 2018
Active Locations (2)
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1
Art Plastic Surgery
Paramus, New Jersey, United States, 07652
2
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, United States, 98207