NCT02755467

Completed

Clinical Evaluation of the Treatment of Spider Angioma

Cutera Inc.Source

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Other study identifiers

Sponsor study identifier

C-16-EV08

Study Type

interventional

Actual enrollment (reported)

22

Locations

1 country

Sites

1

Timeline

Study Start

May 26, 2016

Actual (reported)

Primary Completion

January 13, 2017

Actual (reported)

Study Completion

April 4, 2017

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 22 participants
Study completion date: April 4, 2017
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
April 25, 2016
Actual (reported)
First Posted
April 29, 2016
Actual (reported)
Study Start
May 26, 2016
Actual (reported)
Primary Completion
January 13, 2017
Actual (reported)
Study Completion
April 4, 2017
Actual (reported)
Results Posted
March 24, 2023
Actual (reported)

Last Updated: March 24, 2023
Status Verified: February 2023
Results QC Date: February 27, 2023
Last Update Submitted: February 27, 2023

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 laserDevice

Dual Wavelength Laser Emitting 532 nm Laser Energy

Also known as: Cutera Excel V

Laser treatment

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age5 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (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

Sponsors & Collaborators

Cutera Inc.
Industrylead

Study Sites (1)

DuPage Medical Group

Naperville, Illinois, 60563, United States

MeSH Terms

Interventions

Lasers, Solid-State

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Results Point of Contact

Title: Margot Doucette
Organization: Cutera

Study Officials

Kelly Stankiewicz, MD FAAD
DuPage Medical Group
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

22 participants (actual enrollment reported by the registry).

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

Actual (reported)

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.

Contact the study team to confirm eligibility.

Primary Completion

January 13, 2017

Actual (reported)

Study Completion

April 4, 2017

Actual (reported)

Last Updated

March 24, 2023

Results First Posted

March 24, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02755467
Data provider: ClinicalTrials.gov
Source updated: 2023-03-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:36:10 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Laser treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations