Treatment of Lower Extremity Spider Veins With Excel V

• Sponsor: Cutera Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01362192
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 6
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of a new laser for the removal of unsightly spider veins on the legs. The device used in this study is the Cutera Excel V laser, which is a dual wavelength 532 nm potassium titanyl phosphate (KTP) and 1064 nm neodymium-doped yttrium aluminum garnet (Nd:YAG) laser. The Excel V laser has received 510(k) clearance from the FDA, which means the FDA has approved the laser for dermatological and vascular conditions, like spider veins.

Condition or Disease	Intervention/Treatment	Phase
Telangiectasis; Spider Veins	Device: 532 nm KTP Excel V Laser, manufactured by Cutera, Inc.	Phase 4

Detailed Description

Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins in at least 2, and up to 4, separate areas. Subjects will receive 2 laser treatments spaced 12 weeks apart. Subjects will be followed for 24 weeks (12 weeks after the final laser treatment). Efficacy will be evaluated by blinded independent physician assessment of improvement in treated spider veins using digital photographs taken at baseline and the final follow-up visit by a third-party medical photography service. In addition, efficacy will be evaluated by the Investigator's mean global assessment of improvement and the subject's mean assessment of improvement. Safety will be evaluated by continuous monitoring of adverse events (AEs) and measuring pain associated with laser treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Clinical Evaluation of the Treatment of Lower Extremity Spider Veins Using a Dual Wavelength Laser Emitting 532 nm and 1064 nm Laser Energy
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: 532 nm KTP Laser Treatment	Device: 532 nm KTP Excel V Laser, manufactured by Cutera, Inc.; The 532 nm KTP Excel V laser treatment parameters to be used in this study are as follows: Spot Size: 5 mm Fluence: 13-15 J/cm2 Pulse Duration: 40 ms Epidermal contact-cooling: 5° Celsius; Other Names: Excel V laser ExcelV KTP 532nm

Outcome Measures

Primary Outcome Measures

1. Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments [24 weeks (12 weeks post-final laser treatment)]

   A panel of independent physicians will assess before and after digital photographs of each treated area. The physicians will be blinded to the treatment parameters and to the temporal order of the before and after photographs. Each independent physician will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale: 0 = No Improvement (0%) 1 = Mild Improvement (< 25%) 2 = Moderate Improvement (26 to 50%) 3 = Significant Improvement (51 to 75%) 4 = Very Significant Improvement (76 to 100%)

Secondary Outcome Measures

1. Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments [12 weeks (post-1st laser treatment)]

   The panel of independent physicians will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale: 0 = No Improvement (0%) 1 = Mild Improvement (< 25%) 2 = Moderate Improvement (26 to 50%) 3 = Significant Improvement (51 to 75%) 4 = Very Significant Improvement (76 to 100%)

2. Percent of Subjects With "Significant" or "Very Significant" Improvement in Lower Extremity Spider Veins, as Assessed by the Treating Investigator. [24 weeks (12 weeks post-final laser treatment)]

   The Investigator will perform the Physician's Global Assessment of the degree of improvement for each treated area of the subject's lower extremity spider veins using the following scale: 0 = No Improvement (0%) 1 = Mild Improvement (< 25%) 2 = Moderate Improvement (26 to 50%) 3 = Significant Improvement (51 to 75%) 4 = Very Significant Improvement (76 to 100%)

3. Percent of Subjects With "Significant" to "Very Significant" Improvement of Lower Extremity Spider Veins, as Assessed by Subject. [24 weeks (12 weeks post-final laser treatment)]

   Subjects will be asked to rate the improvement of each treated area of their lower extremity spider veins as compared to baseline using the following scale: 0 = No Improvement (0%) 1 = Mild Improvement (< 25%) 2 = Moderate Improvement (26 to 50%) 3 = Significant Improvement (51 to 75%) 4 = Very Significant Improvement (76 to 100%)

4. Percent of Subjects Satisfied With Improvement of Treated Spider Veins. [24 weeks (12 weeks post-final laser treatment)]

   Subjects will assess their satisfaction with the procedure and with the improvement in lower extremity spider veins at twelve weeks post final laser treatment based using the following scale: 1 = Very Much Not Satisfied 2 = Not Satisfied 3 = Somewhat Satisfied 4 = Satisfied 5 = Very Much Satisfied

5. Mean Pain Score Associated With Laser Treatment. [Day 0 (1st laser treatment)]

   Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain).

6. Mean Pain Score Associated With Laser Treatment [12 weeks (2nd laser treatment)]

   Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Fitzpatrick Skin Type I - III

• Having at least 2 separate areas measuring 5cm x 5cm of lower extremity spider veins

• Having lower extremity spider veins less than 2.0mm in diameter, linear or branching, and red, pink, blue and/or purple in color, as assessed by the Investigator

• Having lower extremity spider veins appropriate for laser treatment, as assessed by the Investigator

• Subject must be able to read, understand and sign the Informed Consent Form

• Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions

• Wiling to have limited sun exposure for the duration of the study, including the follow-up period

• Willingness to have digital photographs taken of lower extremity spider veins

• Agree not to undergo any other procedure for the treatment of lower extremity spider veins during the study

• Willing to not take any 'prn' medications for aches and pains (such as Tylenol® or Advil®) on the days of the laser treatments

• For female candidates - post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study

Exclusion Criteria:

• Having received any prior laser treatment for lower extremity spider veins

• Fitzpatrick Skin Type IV - VI

• Pregnant

• Having an infection, dermatitis or a rash in the treatment area

• Having significant varicosities or perforator veins

• History of keloid scarring, hypertrophic scarring or of abnormal wound healing

• History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications

• History of connective tissue disease, such as systemic lupus erythematosus or scleroderma

• History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation

• Having a known anticoagulative condition or taking anticoagulation medications

• History of thromboembolic disease, such as deep vein thrombosis (DVT)

• History of seizure disorders due to light

• Having a history of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area, unless treatment is conducted following a prophylactic regimen

• Having undergone any surgery in the treatment area within 6 months of treatment (or more if skin has not healed completely)

• Suffering from significant concurrent illness, such as insulin-dependent diabetes (type I or II), peripheral vascular disease or peripheral neuropathy

• Undergoing systemic chemotherapy for the treatment of cancer

• Systemic use of isotretinoin (Accutane®) within 6 months of study participation

• Any use of gold therapy for disorders such as rheumatologic disease or lupus

• 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 three months prior to enrollment or during the study

• As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Main Line Center for Laser Surgery	Ardmore	Pennsylvania	United States	19003

Sponsors and Collaborators

• Cutera Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cutera Inc.
• ClinicalTrials.gov Identifier: NCT01362192
• Other Study ID Numbers: C-11-XLV01
• First Posted: May 30, 2011
• Last Update Posted: Jan 29, 2015
• Last Verified: Jan 1, 2015

• Keywords provided by Cutera Inc.: Telangiectasis; Spider Veins; Excel V; Cutera; Laser; Leg Veins; Venulectasia; Lower Extremity veins; Laser light; KTP; 532nm
• Additional relevant MeSH terms: Telangiectasis; Chlorhexidine; Chlorhexidine gluconate

Study Results

Participant Flow

Arm/Group Title	532 nm KTP Laser Treatment
Arm/Group Description	Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
Period Title: Overall Study
STARTED	20
COMPLETED	16
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	532 nm KTP Laser Treatment
Arm/Group Description	Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	19 95%
>=65 years	1 5%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	48
Sex: Female, Male (Count of Participants)
Female	20 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	20 100%
Fitzpatrick Skin Type (participants) [Number]
I	1 5%
II	15 75%
III	4 20%

Outcome Measures

1. Primary Outcome

Title	Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments
Description	A panel of independent physicians will assess before and after digital photographs of each treated area. The physicians will be blinded to the treatment parameters and to the temporal order of the before and after photographs. Each independent physician will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale: 0 = No Improvement (0%) 1 = Mild Improvement (< 25%) 2 = Moderate Improvement (26 to 50%) 3 = Significant Improvement (51 to 75%) 4 = Very Significant Improvement (76 to 100%)
Time Frame	24 weeks (12 weeks post-final laser treatment)

Outcome Measure Data

Analysis Population Description

per protocol

Arm/Group Title	532 nm KTP Laser Treatment
Arm/Group Description	Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
Measure Participants	16
Mean (95% Confidence Interval) [points on Improvement scale]	2.5

2. Secondary Outcome

Title	Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments
Description	The panel of independent physicians will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale: 0 = No Improvement (0%) 1 = Mild Improvement (< 25%) 2 = Moderate Improvement (26 to 50%) 3 = Significant Improvement (51 to 75%) 4 = Very Significant Improvement (76 to 100%)
Time Frame	12 weeks (post-1st laser treatment)

Outcome Measure Data

Analysis Population Description

per protocol

Arm/Group Title	532 nm KTP Laser Treatment
Arm/Group Description	Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
Measure Participants	16
Mean (95% Confidence Interval) [points on Improvement scale]	1.8

3. Secondary Outcome

Title	Percent of Subjects With "Significant" or "Very Significant" Improvement in Lower Extremity Spider Veins, as Assessed by the Treating Investigator.
Description	The Investigator will perform the Physician's Global Assessment of the degree of improvement for each treated area of the subject's lower extremity spider veins using the following scale: 0 = No Improvement (0%) 1 = Mild Improvement (< 25%) 2 = Moderate Improvement (26 to 50%) 3 = Significant Improvement (51 to 75%) 4 = Very Significant Improvement (76 to 100%)
Time Frame	24 weeks (12 weeks post-final laser treatment)

Outcome Measure Data

Analysis Population Description

per protocol

Arm/Group Title	532 nm KTP Laser Treatment
Arm/Group Description	Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
Measure Participants	16
Number [percent of participants]	69 345%

4. Secondary Outcome

Title	Percent of Subjects With "Significant" to "Very Significant" Improvement of Lower Extremity Spider Veins, as Assessed by Subject.
Description	Subjects will be asked to rate the improvement of each treated area of their lower extremity spider veins as compared to baseline using the following scale: 0 = No Improvement (0%) 1 = Mild Improvement (< 25%) 2 = Moderate Improvement (26 to 50%) 3 = Significant Improvement (51 to 75%) 4 = Very Significant Improvement (76 to 100%)
Time Frame	24 weeks (12 weeks post-final laser treatment)

Outcome Measure Data

Analysis Population Description

per protocol

Arm/Group Title	532 nm KTP Laser Treatment
Arm/Group Description	Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
Measure Participants	16
Number [percent of participants]	75 375%

5. Secondary Outcome

Title	Percent of Subjects Satisfied With Improvement of Treated Spider Veins.
Description	Subjects will assess their satisfaction with the procedure and with the improvement in lower extremity spider veins at twelve weeks post final laser treatment based using the following scale: 1 = Very Much Not Satisfied 2 = Not Satisfied 3 = Somewhat Satisfied 4 = Satisfied 5 = Very Much Satisfied
Time Frame	24 weeks (12 weeks post-final laser treatment)

Outcome Measure Data

Analysis Population Description

per protocol

Arm/Group Title	532 nm KTP Laser Treatment
Arm/Group Description	Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
Measure Participants	16
Number [percent of participants]	100 500%

6. Secondary Outcome

Title	Mean Pain Score Associated With Laser Treatment.
Description	Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain).
Time Frame	Day 0 (1st laser treatment)

Outcome Measure Data

Analysis Population Description

intent-to-treat

Arm/Group Title	532 nm KTP Laser Treatment
Arm/Group Description	Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
Measure Participants	20
Mean (Standard Deviation) [Numeric Pain Rating Score]	3.2 (1.0)

7. Secondary Outcome

Title	Mean Pain Score Associated With Laser Treatment
Description	Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain).
Time Frame	12 weeks (2nd laser treatment)

Outcome Measure Data

Analysis Population Description

intent-to-treat

Arm/Group Title	532 nm KTP Laser Treatment
Arm/Group Description	Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
Measure Participants	20
Mean (Standard Deviation) [Numeric Pain Rating Score]	2.5 (0.9)

Adverse Events

Time Frame	24 weeks
Arm/Group Title	532 nm KTP Laser Treatment
Arm/Group Description	Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
All Cause Mortality
	532 nm KTP Laser Treatment
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	532 nm KTP Laser Treatment
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	532 nm KTP Laser Treatment
	Affected / at Risk (%)	# Events
Total	20/20 (100%)
Skin and subcutaneous tissue disorders
Post-Inflammatory Hyperpigmentation at 24 weeks	1/20 (5%)	1
Mild Edema Immediate Post-TX #1	7/20 (35%)	7
Mild Erythema Immediate Post-TX#1	11/20 (55%)	11
Moderate Erythema Post-TX#1	8/20 (40%)	8
Mild Edema Immediate Post-TX#2	8/20 (40%)	8
Moderate Edema Immediate Post-TX#2	1/20 (5%)	1
Mild Erythema Post-TX#2	13/20 (65%)	13
Moderate Erythema Post-TX#2	1/20 (5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.