Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-24 @ 3:40 PM
NCT ID:
NCT01362192
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT01362192
Study Brief:
Protocol Section:
NCT01362192