Clinical Evaluation of the Treatment of Spider Angioma

Cutera

Status: Completed

Conditions: Spider Angioma

Treatments: Device: KTP laser

Study type: Interventional

Funder types: Industry

Identifiers

NCT02755467

C-16-EV08

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 5 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Laser treatment

Experimental group

Description:

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

Treatment:

Device: KTP laser