Clinical Evaluation of the Treatment of Spider Angioma

NCT ID: NCT02755467

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-26
• Study Completion Date: 2017-04-04

Brief Summary

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

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.

Conditions

Spider Angioma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laser treatment

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

Group Type: EXPERIMENTAL

KTP laser

Intervention Type: DEVICE

Dual Wavelength Laser Emitting 532 nm Laser Energy

Interventions

KTP laser

Dual Wavelength Laser Emitting 532 nm Laser Energy

Intervention Type: DEVICE

Other Intervention Names

Cutera Excel V

Eligibility 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cutera Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelly Stankiewicz, MD FAAD

Role: PRINCIPAL_INVESTIGATOR

DuPage Medical Group

Locations

DuPage Medical Group

Naperville, Illinois, United States

Countries

United States

Other Identifiers

C-16-EV08

Identifier Type: -

Identifier Source: org_study_id