Clinical Evaluation of the Treatment of Spider Angioma

Spider Angioma Clinical Trial

Official title:

A Clinical Evaluation of the Treatment of Spider Angioma Using a Dual Wavelength Laser Emitting 532 nm Laser Energy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02755467
• Other study ID #: C-16-EV08
• Status: Completed
• Phase: N/A
• Start date: May 26, 2016
• Est. completion date: April 4, 2017

Study information

• Verified date: February 2023
• Source: Cutera Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 4, 2017
• Est. primary completion date: January 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemangioma
• Spider Angioma

Intervention

Device:
• KTP laser
Dual Wavelength Laser Emitting 532 nm Laser Energy

Locations

Country	Name	City	State
United States	DuPage Medical Group	Naperville	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Cutera Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physician's Global Assessment Scale for Improvement of Spider Angioma	Assessment of Baseline vs. 4 weeks post-final treatment for improvement of spider angiomas using the Physician's Global Assessment scale.; High scores indicate better outcomes: 0. None; Mild; Moderate; Significant; Very Significant; Complete Removal	Four weeks post laser treatment.