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

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ClinicalTrials.gov Identifier: NCT01810484
Recruitment Status : Completed
First Posted : March 13, 2013
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Merz North America, Inc. ( Ulthera, Inc )

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.

Condition or disease Intervention/treatment Phase
Scars Striae Device: Ultherapy® treatment only Device: Ultherapy® treatment and CO2 laser treatment Device: CO2 Laser treatment only Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: 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 Start Date : January 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group 1

The abdominal region will be divided into 3 treatment areas: Treatment Area A, B and C.

Treatment Area A will be treated with Ultherapy® treatment only; Treatment Area B will be treated with Ultherapy® treatment and CO2 laser treatment; Treatment Area C will be treated with CO2 laser treatment only

Device: Ultherapy® treatment only
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ulthera® System treatment

Device: Ultherapy® treatment and CO2 laser treatment

Ultherapy® treatment: Focused ultrasound energy delivered below the surface of the skin;

CO2 Laser: Fractionated energy delivered to the surface of the skin for ablative and thermal injury to the skin layers for resurfacing the skin.

Other Names:
  • Ulthera® System treatment
  • CO2 Fractional Ablative Laser teatment

Device: CO2 Laser treatment only
CO2 Laser: Fractionated energy delivered to the surface of the skin for ablative and thermal injury to the skin layers for resurfacing the skin.
Other Name: CO2 Fractional Ablative Laser teatment

Active Comparator: Group 2

The abdominal region will be divided into 3 treatment areas: Treatment Area A, B and C.

Treatment Area A will be treated with Ultherapy® treatment and CO2 laser treatment; Treatment Area B will be treated with CO2 laser treatment only; Treatment Area C will be treated with Ultherapy® treatment only

Device: Ultherapy® treatment only
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ulthera® System treatment

Device: Ultherapy® treatment and CO2 laser treatment

Ultherapy® treatment: Focused ultrasound energy delivered below the surface of the skin;

CO2 Laser: Fractionated energy delivered to the surface of the skin for ablative and thermal injury to the skin layers for resurfacing the skin.

Other Names:
  • Ulthera® System treatment
  • CO2 Fractional Ablative Laser teatment

Device: CO2 Laser treatment only
CO2 Laser: Fractionated energy delivered to the surface of the skin for ablative and thermal injury to the skin layers for resurfacing the skin.
Other Name: CO2 Fractional Ablative Laser teatment

Active Comparator: Group 3

The abdominal region will be divided into 3 treatment areas: Treatment Area A, B and C.

Treatment Area A will be treated with CO2 laser treatment only; Treatment Area B will be treated with Ultherapy® treatment only; Treatment Area C will be treated with Ultherapy® treatment and CO2 laser treatment

Device: Ultherapy® treatment only
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ulthera® System treatment

Device: Ultherapy® treatment and CO2 laser treatment

Ultherapy® treatment: Focused ultrasound energy delivered below the surface of the skin;

CO2 Laser: Fractionated energy delivered to the surface of the skin for ablative and thermal injury to the skin layers for resurfacing the skin.

Other Names:
  • Ulthera® System treatment
  • CO2 Fractional Ablative Laser teatment

Device: CO2 Laser treatment only
CO2 Laser: Fractionated energy delivered to the surface of the skin for ablative and thermal injury to the skin layers for resurfacing the skin.
Other Name: CO2 Fractional Ablative Laser teatment




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 90 Day Patient Satisfaction [ Time Frame: 90 Days post-treatment ]
    Based on completion of Patient Satisfaction Questionnaires

  2. 180 Day Patient Satisfaction [ Time Frame: 180 Days post-treatment ]
    Based on completion of Patient Satisfaction Questionnaires

  3. Change from baseline in overall aesthetic appearance of abdominal striae at 90 days [ Time Frame: 90 Days post-treatment ]
    Assessment of change in overall aesthetic appearance of abdominal striae from baseline to 90 days post-treatment based on review of pretreatment and 90 day post-treatment 2D images and a live assessment of the treatment area

  4. Change from baseline in overall aesthetic appearance of abdominal striae at 180 days [ Time Frame: 180 Days post-treatment ]
    Assessment of change in overall aesthetic appearance of abdominal striae from baseline to 180 days post-treatment based on review of pretreatment and 180 day post-treatment 2D images and a live assessment of the treatment area

  5. Change from baseline in skin striae texture and depth at 90 Days [ Time Frame: 90 Days post-treatment ]
    Quantitative analysis will be completed comparing 3D images obtained at baseline to 3D images obtained at 90 days post-treatment.

  6. Change from baseline in skin striae texture and depth at 180 Days [ Time Frame: 180 Days post-treatment ]
    Quantitative analysis will be completed comparing 3D images obtained at baseline to 3D images obtained at 180 days post-treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810484


Locations
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United States, New Jersey
Art Plastic Surgery
Paramus, New Jersey, United States, 07652
United States, North Carolina
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, United States, 98207
Sponsors and Collaborators
Ulthera, Inc
Investigators
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Principal Investigator: Luis Zapiach, MD Art Plastic Surgery

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Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01810484     History of Changes
Other Study ID Numbers: ULT-133
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2015
Keywords provided by Merz North America, Inc. ( Ulthera, Inc ):
Ulthera® System
Ultherapy® Treatment
Ulthera, Inc.
Ultrasound treatment for skin
Additional relevant MeSH terms:
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Striae Distensae
Skin Manifestations
Signs and Symptoms