Feasibility Study: Ulthera System for the Treatment of Rosacea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01756027
First received: December 19, 2012
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

Up to 12 subjects will be enrolled. Enrolled subjects will receive one or two Ultherapy treatments on the cheeks, depending on their assigned study group. Follow-up visits will occur 14, 30 and 90 days post-treatment. Study images will be obtained pre-treatment, 30-60 min post-treatment, and at each follow-up visit.


Condition Intervention
Erythematotelangiectatic Rosacea
Device: Ulthera System providing one treatment per cheek
Device: Ulthera System providing two treatments per cheek

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility Study: Evaluation of the Effectiveness and Safety of the Ulthera® System for Treatment of Erythematotelangiectatic Rosacea

Resource links provided by NLM:


Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • Improvement in Erythematotelangiectatic Rosacea of treatment area versus control [ Time Frame: 90-days post-treatment treatment ] [ Designated as safety issue: No ]
    As determined by Primary Investigator assessment


Secondary Outcome Measures:
  • Improvement in Erythematotelangiectatic Rosacea of treatment area versus control (untreated area) [ Time Frame: Participants will be followed for 90-days post treatment #1 (Group A) or post-treatment #2 (Group B) ] [ Designated as safety issue: No ]
    As determined by a live patient assessment and investigator designation of improved versus not improved for the area treated compared to the surrounding area at follow-up in Phase I


Enrollment: 12
Study Start Date: November 2012
Study Completion Date: October 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A
Ulthera System providing one treatment per cheek
Device: Ulthera System providing one treatment per cheek
Focused ultrasound energy delivered below the surface of the skin per cheek.
Other Name: Ultherapy™
Active Comparator: Group B
Ulthera System providing two treatments per cheek
Device: Ulthera System providing two treatments per cheek
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ultherapy™

Detailed Description:

This study is a prospective, randomized, single-center clinical trial. The study will be conducted in two Phases. In Phase I, subjects will be assigned to one of two treatment groups. One study group will receive one dual depth Ultherapy treatment to a region on the cheeks, and one study group will receive two dual depth Ultherapy treatments to a region on the cheeks 14 days apart. Average pain scores will be obtained using a Numeric Rating Scale following each region of treatment and for each depth of treatment. In Phase II, based on observations of last follow-up visit in Phase I (at 90 days after treatment), subjects will be given the option to receive treatment of the affected area(s) for the protocol specified region, treated at the treatment depth showing the most efficacy in Phase I. Efficacy will be determined by improvement in Erythematotelangiectatic Rosacea in the treatment area versus control (an untreated area) as determined by primary investigator assessment at the last follow-up visit in Phase I.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, aged 18 to 65 years.
  • Subject in good health.
  • Clinical diagnosis of Erythematotelangiectatic Rosacea.
  • 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.

Exclusion Criteria:

  • Presence of an active systemic disease that may affect wound healing.
  • Prominent telangiectases in the area(s) to be treated.
  • History of post-inflammatory hyperpigmentation.
  • Papulopustular or Phymatous Rosacea.
  • Severe solar elastosis.
  • Significant scarring in area(s) to be treated.
  • Open wounds or lesions in the area(s) to be treated.
  • Severe or cystic acne on the area(s) to be treated.
  • Presence of a metal stent or implant in the area(s) to be treated.
  • Inability to understand the protocol or to give informed consent.
  • Microdermabrasion, or prescription level glycolic acid treatments to the intended treatment area(s) within six weeks prior to study participation or during the study.
  • Marked asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
  • 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 the following cosmetic treatments in the area(s) to be treated:

    1. Skin tightening procedure within the past year;
    2. Injectable filler of any type within the past:

      • 12 months for Hyaluronic acid fillers (e.g.,Restylane)
      • 12 months for Ca Hydroxyapatite fillers (e.g., Radiesse)
      • 24 months for Poly-L-Lactic acid fillers (e.g., Sculptra)
      • Ever for permanent fillers (e.g., Silicone, ArteFill)
    3. Neurotoxins within the past three months;
    4. Ablative resurfacing laser treatment;
    5. Nonablative, rejuvenative laser or light treatment within the past six months;
    6. Surgical dermabrasion or deep facial peels
  • History of using the following prescription medications:

    1. Accutane or other systemic retinoids within the past six months;
    2. Topical Retinoids within the past two weeks;
    3. Antiplatelet agents / Anticoagulants (Coumadin, Heparin, Plavix);
    4. Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01756027

Locations
Canada, British Columbia
Cosmedica
Victoria, British Columbia, Canada, V8R 6V4
Sponsors and Collaborators
Ulthera, Inc
Investigators
Principal Investigator: Mark Lupin, M.D. Cosmedica
  More Information

No publications provided

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01756027     History of Changes
Other Study ID Numbers: ULT-131
Study First Received: December 19, 2012
Last Updated: November 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ulthera, Inc:
Rosacea
Ulthera System
Ultherapy™ Treatment
Ulthera, Inc.
Ultrasound treatment for the skin

Additional relevant MeSH terms:
Rosacea
Skin Diseases

ClinicalTrials.gov processed this record on July 22, 2014