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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.

April 25, 2016
April 29, 2016
September 14, 2017
May 26, 2016
January 13, 2017   (Final data collection date for primary outcome measure)
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
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. ]
Complete list of historical versions of study NCT02755467 on ClinicalTrials.gov Archive Site
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
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. ]
Not Provided
Not Provided
 
Clinical Evaluation of the Treatment of Spider Angioma
A Clinical Evaluation of the Treatment of Spider Angioma Using a Dual Wavelength Laser Emitting 532 nm Laser Energy
To evaluate the safety and effectiveness of the laser treatment for the treatment of spider angiomas.
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.
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Spider Angioma
Device: KTP laser
Dual Wavelength Laser Emitting 532 nm Laser Energy
Other Name: Cutera Excel V
Experimental: Laser treatment
Each subject will receive a 532 nm KTP laser treatment for their spider angioma(s).
Intervention: Device: KTP laser
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
25
April 4, 2017
January 13, 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
5 Years to 65 Years   (Child, Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02755467
C-16-EV08
No
Not Provided
Plan to Share IPD: Undecided
Cutera Inc.
Cutera Inc.
Not Provided
Principal Investigator: Kelly Stankiewicz, MD FAAD DuPage Medical Group
Cutera Inc.
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP