Clinical Evaluation of the Treatment of Spider Angioma

NCT02755467 | Completed Results

• 1 other identifier: C-16-EV08
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spider Angioma

Outcome Measures

Primary Outcomes (1)

• 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 1. Mild 2. Moderate 3. Significant 4. Very Significant 5. Complete Removal

  Four weeks post laser treatment.

Study Arms (1)

Laser treatment

EXPERIMENTAL

Each subject will receive a 532 nm KTP laser treatment for their spider angioma(s).

Device: KTP laser

Interventions

KTP laser DEVICE

Dual Wavelength Laser Emitting 532 nm Laser Energy

Also known as: Cutera Excel V

Laser treatment

Eligibility Criteria

• Age: 5 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females, 5 to 65 years of age (inclusive).
• Fitzpatrick Skin Types I-IV
• Subject must be able to read, understand and sign the Informed Consent Form.
• 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.
• Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
• Willing to have limited sun exposure for the duration of the study, including the follow-up period.
• Willingness to have digital photographs taken of their spider angioma(s) and agree to use of photographs for presentation, educational or marketing purposes
• Agree not to undergo any other procedure for the treatment of spider angioma during the study.

You may not qualify if:

• Pregnant.
• History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
• Having a known anti-coagulative condition or taking anticoagulation medications, including aspirin.
• History of seizure disorders due to light.
• Systemic use of isotretinoin (Accutane®) within 6 months of study participation.
• Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
• Participation in a study of another device or drug within 3 months prior to enrollment or during the study.
• 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.

Sponsors & Collaborators

• Cutera Inc.: lead

Study Sites (1)

DuPage Medical Group

Naperville, Illinois, 60563, United States

Location

MeSH Terms

Interventions

Lasers, Solid-State

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Results Point of Contact

• Title: Margot Doucette
• Organization: Cutera

mdoucette@cutera.com

415-657-5518

Study Officials

• Kelly Stankiewicz, MD FAAD

  DuPage Medical Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: April 29, 2016
• Study Start: May 26, 2016
• Primary Completion: January 13, 2017
• Study Completion: April 4, 2017
• Last Updated: March 24, 2023
• Results First Posted: March 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)