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Clinical Evaluation of the Treatment of Spider Angioma

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ClinicalTrials.gov Identifier: NCT02755467
Recruitment Status : Completed
First Posted : April 29, 2016
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Cutera Inc.

Brief Summary:
To evaluate the safety and effectiveness of the laser treatment for the treatment of spider angiomas.

Condition or disease Intervention/treatment Phase
Spider Angioma Device: KTP laser Not Applicable

Detailed Description:
The purpose of this study is to evaluate the safety and efficacy of the 532 nm KTP laser within the Cutera Excel V system for the treatment of spider angiomas.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Evaluation of the Treatment of Spider Angioma Using a Dual Wavelength Laser Emitting 532 nm Laser Energy
Actual Study Start Date : May 26, 2016
Actual Primary Completion Date : January 13, 2017
Actual Study Completion Date : April 4, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birthmarks

Arm Intervention/treatment
Experimental: Laser treatment
Each subject will receive a 532 nm KTP laser treatment for their spider angioma(s).
Device: KTP laser
Dual Wavelength Laser Emitting 532 nm Laser Energy
Other Name: Cutera Excel V




Primary Outcome Measures :
  1. The investigator will perform a baseline assessment of the spider angiomas and compare the degree of improvement for each treated lesion at 4 weeks post-final treatment using the Physician's Global Assessment scale. [ Time Frame: Four weeks post laser treatment. ]
    assessment of Baseline vs. 4 weeks post-final treatment for improvement of spider angiomas


Secondary Outcome Measures :
  1. At 4 weeks post-final treatment, subjects will be asked to rate their level of satisfaction with the laser treatment outcome and the overall laser treatment procedure, using the Subject Satisfaction Assessment Scale. [ Time Frame: Four weeks post laser treatment. ]
    Subject satisfaction assessment of laser outcome and procedure at 4 weeks post-final treatment



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Ages Eligible for Study:   5 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males or females, 5 to 65 years of age (inclusive).
  2. Fitzpatrick Skin Types I-IV
  3. Subject must be able to read, understand and sign the Informed Consent Form.
  4. If subject is a minor (<18 years old in Illinois), Assent must be obtained from the subject and a Parental Consent Form must be signed by the parents or legal guardian.
  5. Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
  6. Willing to have limited sun exposure for the duration of the study, including the follow-up period.
  7. Willingness to have digital photographs taken of their spider angioma(s) and agree to use of photographs for presentation, educational or marketing purposes
  8. Agree not to undergo any other procedure for the treatment of spider angioma during the study.

Exclusion Criteria:

  1. Pregnant.
  2. History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
  3. Having a known anti-coagulative condition or taking anticoagulation medications, including aspirin.
  4. History of seizure disorders due to light.
  5. Systemic use of isotretinoin (Accutane®) within 6 months of study participation.
  6. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
  7. Participation in a study of another device or drug within 3 months prior to enrollment or during the study.
  8. In the opinion of the investigator, any physical or mental condition which might make it unsafe for the subject to participate in this study or which requires systemic therapy that could interfere with this research study.

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): NCT02755467


Locations
United States, Illinois
DuPage Medical Group
Naperville, Illinois, United States, 60563
Sponsors and Collaborators
Cutera Inc.
Investigators
Principal Investigator: Kelly Stankiewicz, MD FAAD DuPage Medical Group

Responsible Party: Cutera Inc.
ClinicalTrials.gov Identifier: NCT02755467     History of Changes
Other Study ID Numbers: C-16-EV08
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms