Trial Outcomes & Findings for A Clinical Evaluation of the Treatment of Spider Veins on the Ankles (NCT NCT02754479)

Last Updated: 2023-05-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

4 participants

Primary outcome timeframe

Four weeks post final laser treatment.

Results posted on

2023-05-09

Participant Flow

Participant milestones

Participant milestones
Measure	Laser Treatments Each subject will receive a combination of 532 nm and/or 1064 nm Nd:YAG laser treatment on lower extremity spider veins. Darker colored veins located deeper in the dermis are likely to be treated with the 1064 nm Nd:YAG laser. Lighter colored, smaller veins located more superficially are likely to be treated with the 532 nm laser. The intent of the study was not to compare the level of treatment (e.g 532 nm vs 1064nm)
Overall Study STARTED	4
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Laser Treatments Each subject will receive a combination of 532 nm and/or 1064 nm Nd:YAG laser treatment on lower extremity spider veins. Darker colored veins located deeper in the dermis are likely to be treated with the 1064 nm Nd:YAG laser. Lighter colored, smaller veins located more superficially are likely to be treated with the 532 nm laser. The intent of the study was not to compare the level of treatment (e.g 532 nm vs 1064nm)
Overall Study Lost to Follow-up	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Laser Treatments n=4 Participants Each subject will receive a combination of 532 nm \\and/or 1064 nm Nd:YAG laser treatment on lower extremity spider veins
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Four weeks post final laser treatment.

Population: 1 enrolled participant was lost to follow-up prior to receiving treatment

Outcome measures

Outcome measures
Measure	Laser Treatments n=3 Participants Each subject will receive a combination of 532 nm and/or 1064 nm Nd:YAG laser treatment on lower extremity spider veins.
Physician Global Assessment of Improvement in Treated Spider Veins on the Ankles	3.7 score on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: Four weeks post final laser treatment

Population: 1 enrolled participant was lost to follow-up prior to receiving 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.

Outcome measures

Outcome measures
Measure	Laser Treatments n=3 Participants Each subject will receive a combination of 532 nm and/or 1064 nm Nd:YAG laser treatment on lower extremity spider veins.
Subject Satisfaction With Improvement in Treated Spider Veins on the Ankles	4.3 score on a scale Standard Deviation 1.2

Adverse Events

Laser Treatments

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Laser Treatments n=3 participants at risk Each subject will receive a combination of 532 nm and/or 1064 nm Nd:YAG laser treatment on lower extremity spider veins.
Skin and subcutaneous tissue disorders Erythema	100.0% 3/3 • Treatment through 4-weeks post final treatment, up to 6 months Definition of adverse event and/or serious adverse event, used to collect adverse event information, did not differ from the clinicaltrials.gov.
Skin and subcutaneous tissue disorders Edema	33.3% 1/3 • Treatment through 4-weeks post final treatment, up to 6 months Definition of adverse event and/or serious adverse event, used to collect adverse event information, did not differ from the clinicaltrials.gov.
Skin and subcutaneous tissue disorders Discomfort	66.7% 2/3 • Treatment through 4-weeks post final treatment, up to 6 months Definition of adverse event and/or serious adverse event, used to collect adverse event information, did not differ from the clinicaltrials.gov.
Skin and subcutaneous tissue disorders Post Inflammatory Hyperpigmentation	100.0% 3/3 • Treatment through 4-weeks post final treatment, up to 6 months Definition of adverse event and/or serious adverse event, used to collect adverse event information, did not differ from the clinicaltrials.gov.
Skin and subcutaneous tissue disorders Darkening of Vessel	66.7% 2/3 • Treatment through 4-weeks post final treatment, up to 6 months Definition of adverse event and/or serious adverse event, used to collect adverse event information, did not differ from the clinicaltrials.gov.
Skin and subcutaneous tissue disorders Purpura	33.3% 1/3 • Treatment through 4-weeks post final treatment, up to 6 months Definition of adverse event and/or serious adverse event, used to collect adverse event information, did not differ from the clinicaltrials.gov.
Skin and subcutaneous tissue disorders Crusting	33.3% 1/3 • Treatment through 4-weeks post final treatment, up to 6 months Definition of adverse event and/or serious adverse event, used to collect adverse event information, did not differ from the clinicaltrials.gov.
Skin and subcutaneous tissue disorders Nodule	33.3% 1/3 • Treatment through 4-weeks post final treatment, up to 6 months Definition of adverse event and/or serious adverse event, used to collect adverse event information, did not differ from the clinicaltrials.gov.

Additional Information

Kelly Stankiewicz, MD FAAD

DuPage Medical Group

Phone: (630) 547-5040

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place