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NCT02754479

A Clinical Evaluation of the Treatment of Spider Veins on the Ankles

Completed NA Results posted Last updated 9 May 2023
What this trial tests

NA trial testing Nd:YAG laser in Spider Veins in 4 participants. Completed in 15 March 2017.

Timeline
10 June 2016
Primary endpoint
22 December 2016
15 March 2017

Quick facts

Lead sponsorCutera Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment4
Start date10 June 2016
Primary completion22 December 2016
Estimated completion15 March 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Cutera Inc.

Who can join

Adults 20 to 75, any sex, with Spider Veins. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Physician Global Assessment of Improvement in Treated Spider Veins on the Ankles Primary · Four weeks post final laser treatment.

Improvement in treated ankle spider veins at 4 weeks post final laser treatment (compared to baseline) as assessed by a blinded evaluators Physician Global Assessment Scale score (Min=0; 4= Max). Higher Score Indicates Better Outcome.

GroupValue95% CI
Laser Treatments3.7± 0.6
Subject Satisfaction With Improvement in Treated Spider Veins on the Ankles Secondary · Four weeks post final laser treatment

Subject satisfaction with improvement in spider veins on the ankles as assessed using the Subject Satisfaction Assessment scale (Min=1, Max=5) at 4 weeks post final treatment. Higher score indicates better outcome.

GroupValue95% CI
Laser Treatments4.3± 1.2

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment through 4-weeks post final treatment, up to 6 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Laser Treatments
Serious: 0/3 (0%)
Deaths: 0/3
Other adverse events (8 terms — click to expand)

ReactionSystemLaser Treatments
ErythemaSkin and subcutaneous tissue disorders
Post Inflammatory HyperpigmentationSkin and subcutaneous tissue disorders
DiscomfortSkin and subcutaneous tissue disorders
Darkening of VesselSkin and subcutaneous tissue disorders
EdemaSkin and subcutaneous tissue disorders
PurpuraSkin and subcutaneous tissue disorders
CrustingSkin and subcutaneous tissue disorders
NoduleSkin and subcutaneous tissue disorders

Data from ClinicalTrials.gov NCT02754479 adverse events section.

Sponsor's own description

To evaluate the safety and effectiveness of the Excel V system for the treatment of lower extremity spider veins on the ankles.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of Nd:YAG laser

Trials testing the same drug.

Other Cutera Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02754479.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing